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Direct-to-Consumer Testing’s Expansion to Rheumatology Has Benefits but Potential Risks
When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.
Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.
“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”
She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.
“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.
But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.
At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
A Growing Market
Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.
Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.
But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.
The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.
Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
Oversight and Quality Control
Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.
“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”
Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”
At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.
“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.
“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
The DTC Landscape in Rheumatology
Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.
“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”
Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.
“I’m a big fan of patient empowerment, and I do think that medicine serves a gatekeeper role that sometimes can be a little too far,” Dr. Putman said. “I think there is value to patients being able to get more information and try to understand what is happening in their bodies. I have a lot of compassion for someone who would try to find testing outside of the normal channels.”
Indeed, bringing these test results to a visit could be informative in some scenarios. A negative ANA test, for example, pretty much excludes lupus 100%, Dr. Kim said. But a positive ANA doesn’t tell him much, and if his clinical suspicion for a condition is high, he likely would order that test anyway, even if the patient came in with their own results. Dr. Putman also pointed out that the vast majority of tests used in rheumatology have a high rate of false positives.
“I think that will be the major area where this causes quite a lot of grief to patients and some frustration to some providers,” he said. A rheumatoid factor test like the one Ms. Welsh ordered, for example, might test positive in 10 out of 100 people randomly gathered in a room, but the majority of those individuals would not have RA, he said.
That test is another popular rheumatology one, according to Timothy Niewold, MD, vice chair for research in the Hospital for Special Surgery Department of Medicine in New York City. Among the possible reasons people might order these tests are the delay in diagnosis that can often occur with a lot of rheumatologic conditions and that “it can take a while to see a rheumatologist, depending on what part of the country you’re in and what the availability is,” he said. He’s not surprised to see tests for Sjögren disease among the offerings, for example, because it’s a condition that’s difficult to diagnose but reasonably common within autoimmune diseases.
Risks vs Benefits
DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.
“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”
Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.
The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.
“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”
Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”
Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”
It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.
“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”
Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
Patient-Provider Relationship Friction
Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.
But physicians know that’s not the case for many conditions, particularly those in rheumatology.
“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”
But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”
Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.
“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”
Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
Responding to Patients
Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.
“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.
While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.
“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”
That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.
“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”
Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.
Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”
It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.
“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”
Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
A version of this article first appeared on Medscape.com.
When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.
Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.
“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”
She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.
“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.
But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.
At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
A Growing Market
Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.
Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.
But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.
The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.
Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
Oversight and Quality Control
Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.
“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”
Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”
At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.
“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.
“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
The DTC Landscape in Rheumatology
Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.
“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”
Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.
“I’m a big fan of patient empowerment, and I do think that medicine serves a gatekeeper role that sometimes can be a little too far,” Dr. Putman said. “I think there is value to patients being able to get more information and try to understand what is happening in their bodies. I have a lot of compassion for someone who would try to find testing outside of the normal channels.”
Indeed, bringing these test results to a visit could be informative in some scenarios. A negative ANA test, for example, pretty much excludes lupus 100%, Dr. Kim said. But a positive ANA doesn’t tell him much, and if his clinical suspicion for a condition is high, he likely would order that test anyway, even if the patient came in with their own results. Dr. Putman also pointed out that the vast majority of tests used in rheumatology have a high rate of false positives.
“I think that will be the major area where this causes quite a lot of grief to patients and some frustration to some providers,” he said. A rheumatoid factor test like the one Ms. Welsh ordered, for example, might test positive in 10 out of 100 people randomly gathered in a room, but the majority of those individuals would not have RA, he said.
That test is another popular rheumatology one, according to Timothy Niewold, MD, vice chair for research in the Hospital for Special Surgery Department of Medicine in New York City. Among the possible reasons people might order these tests are the delay in diagnosis that can often occur with a lot of rheumatologic conditions and that “it can take a while to see a rheumatologist, depending on what part of the country you’re in and what the availability is,” he said. He’s not surprised to see tests for Sjögren disease among the offerings, for example, because it’s a condition that’s difficult to diagnose but reasonably common within autoimmune diseases.
Risks vs Benefits
DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.
“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”
Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.
The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.
“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”
Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”
Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”
It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.
“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”
Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
Patient-Provider Relationship Friction
Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.
But physicians know that’s not the case for many conditions, particularly those in rheumatology.
“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”
But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”
Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.
“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”
Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
Responding to Patients
Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.
“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.
While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.
“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”
That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.
“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”
Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.
Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”
It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.
“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”
Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
A version of this article first appeared on Medscape.com.
When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.
Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.
“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”
She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.
“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.
But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.
At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
A Growing Market
Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.
Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.
But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.
The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.
Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
Oversight and Quality Control
Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.
“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”
Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”
At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.
“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.
“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
The DTC Landscape in Rheumatology
Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.
“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”
Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.
“I’m a big fan of patient empowerment, and I do think that medicine serves a gatekeeper role that sometimes can be a little too far,” Dr. Putman said. “I think there is value to patients being able to get more information and try to understand what is happening in their bodies. I have a lot of compassion for someone who would try to find testing outside of the normal channels.”
Indeed, bringing these test results to a visit could be informative in some scenarios. A negative ANA test, for example, pretty much excludes lupus 100%, Dr. Kim said. But a positive ANA doesn’t tell him much, and if his clinical suspicion for a condition is high, he likely would order that test anyway, even if the patient came in with their own results. Dr. Putman also pointed out that the vast majority of tests used in rheumatology have a high rate of false positives.
“I think that will be the major area where this causes quite a lot of grief to patients and some frustration to some providers,” he said. A rheumatoid factor test like the one Ms. Welsh ordered, for example, might test positive in 10 out of 100 people randomly gathered in a room, but the majority of those individuals would not have RA, he said.
That test is another popular rheumatology one, according to Timothy Niewold, MD, vice chair for research in the Hospital for Special Surgery Department of Medicine in New York City. Among the possible reasons people might order these tests are the delay in diagnosis that can often occur with a lot of rheumatologic conditions and that “it can take a while to see a rheumatologist, depending on what part of the country you’re in and what the availability is,” he said. He’s not surprised to see tests for Sjögren disease among the offerings, for example, because it’s a condition that’s difficult to diagnose but reasonably common within autoimmune diseases.
Risks vs Benefits
DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.
“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”
Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.
The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.
“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”
Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”
Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”
It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.
“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”
Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
Patient-Provider Relationship Friction
Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.
But physicians know that’s not the case for many conditions, particularly those in rheumatology.
“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”
But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”
Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.
“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”
Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
Responding to Patients
Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.
“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.
While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.
“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”
That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.
“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”
Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.
Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”
It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.
“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”
Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
A version of this article first appeared on Medscape.com.
Patient Navigators in Rheumatology Set to Expand in Importance, Scope With New Medicare Codes
When a large rheumatology clinic in Richmond, Virginia, heard that Medicare would be reimbursing patient navigators, they decided to launch their own virtual navigator program.
“We read about it and felt like it was the perfect representation of what we were already trying to do,” said Blake Wehman, founder and CEO of Remission Medical, which offers virtual diagnosis and longitudinal care in rheumatology.
Mr. Wehman has plans to start submitting for these principal illness navigation (PIN) codes in 2025.
The Centers for Medicare & Medicaid Services (CMS) in 2024 began paying navigators who assist Medicare patients with high-risk conditions, which could include rheumatologic diseases. “The codes are not limited to a specific set of diagnoses; rather, the definition of a serious, high-risk condition is dependent on clinical judgment,” the agency clarified.
CMS established this provision in the CY 2024 Physician Fee Schedule final rule.
Reimbursing patient navigators is long overdue, noted Edith Williams, PhD, MS, director of the Center for Community Health and Prevention and founding director of the Office of Health Equity Research at the University of Rochester in New York. “It’s something our patients need. It’s something that the science is telling us can impact outcomes as an adjunct to clinical care,” she said. 
Dr. Williams said the new CMS codes “got our departments talking about what this policy is and how it would translate into patient care.”
The codes apply when navigators are assigned to support patients with high-risk conditions who need assistance connecting with clinical and other resources, including any unmet social determinants of health needs, or in diagnosis or treatment of their medical problems.
“Having a navigator by their side to help get through all the clinical and administrative challenges gives people an advocate and a partner who is with them and their families every step of the way to help make the journey easier,” said a CMS spokesperson.
Not all navigator programs may qualify for the new codes. Some are supported by grants and don’t bill patient insurance. However, they all share a common goal: to guide patients through the healthcare continuum and assist with appointments and medication adherence.
Identifying ‘Root Causes’ of Barriers
Navigators represent a wide variety of backgrounds, ranging from healthcare professionals to students or even patients themselves. They generally don’t provide medical advice. “However, we are responsible for making sure our patients and their families are educated and aware, then assist with guidance on their path,” said Katie Costillo, BSW, CPPN, patient navigator and program manager with the Lupus Foundation of America, Heartland Region.
“Training and experience in engaging and building rapport is essential to assisting patients overcome obstacles that limit their access to healthcare,” she said. Narrowing down with patients the root causes of their barriers and then identifying appropriate and available community resources is key.
Studies have demonstrated the effectiveness of adding a navigator to a rheumatology patient’s care plan. In one study, a group of Boston researchers determined that navigators played a useful role in reducing adherence barriers to oral disease-modifying antirheumatic drugs. The navigators uncovered several concerns among 107 rheumatology patients, including fear of adverse events and medication effectiveness.
They also helped to facilitate patient-physician communication, developed strategies to improve medication adherence, and provided medication and diagnosis education. Patients reported satisfaction with the navigator experience.
A study Dr. Williams coauthored that examined behavioral interventions to support African American women with systemic lupus erythematosus found that patient navigator participants had superior coping scores, compared with those engaged in peer-to-peer methodology and patient support groups.
“We had a lot of success with the mentorship program, too,” Dr. Williams said. Navigator services, however, offer more one-on-one attention, “and it’s more tailored to what the person needs rather than the set curriculum that the mentors delivered to their mentees.”
Supporting Patients With Lupus
Ideally, navigators should be able to relate to patients and know what they’re going through, Dr. Williams said. This is someone whom the patient can trust and depend on. “That’s where the benefit of having someone who is also a patient lies because they’re ultimately relatable to other patients. But different institutions have taken different approaches to this.”
Some programs focus on specific rheumatologic conditions. The Lupus Foundation of America, for example, established patient navigator programs to assist patients with lupus in four markets across the country.
The Heartland patient navigator program is available for all patients with lupus within its region, which includes Kansas, Missouri, and central and southern Illinois. As a navigator, Ms. Costillo has been assisting patients since 2022. In 2023, she began meeting with patients at the Washington University Lupus Clinic (WULC) in St. Louis, Missouri.
Navigators work directly with patients before and after their appointment to ensure follow-up and reduce missed appointments. “They help lupus patients connect with community services and overcoming barriers to access and care. The goal of this position is to improve overall disease management, which results in better health outcomes,” Ms. Costillo said.
Since its inception, the patient navigator program at WULC has shown a decrease in patient no-call no-shows and an increase in requests to reschedule as opposed to not showing up for their scheduled appointment, based on history.
Patients have reported fewer barriers to transportation and improvement in access to resources, support, and disease education. “Our patients have also stated [that] meeting with the navigator during their appointments has helped them to feel heard, understood, and supported,” Ms. Costillo said.
Navigator Work Is Not Without Challenges
A total of 90% of patients with lupus are women, and women of color are two to three times more likely to develop lupus in their lifetime.
“Based on socioeconomic statistics, lupus patients are in a demographic that is commonly underserved, underfunded, and often overlooked. Finding appropriate local community resources for a patient who must choose between feeding her family or paying for transportation to multiple physician appointments is a common problem,” Ms. Costillo said.
Much of the assistance that became available during the COVID pandemic is starting to disappear. “With the rising costs of daily living, we are having to find creative and alternative ways to break down barriers and find support to fill those gaps,” she continued.
Getting insurance coverage of patients is another challenge. Many patients with lupus will be prescribed a treatment that insurance refuses to cover even after the physician disputes it.
Additionally, many patients with lupus are unable to work to support their family. A majority who apply for Social Security Disability Insurance are denied on their first and second attempts, “requiring multiple hearings and pages of documentation from their physicians,” Ms. Costillo said.
Students Serve as Navigators
One inner-city program is seeking to increase access to healthcare services to patients with lupus and lupus nephritis in underserved communities. In 2021, SUNY Downstate Health Sciences University in New York City, in partnership with the Brooklyn Free Clinic and Brooklyn Health Disparities Center, launched a program to teach navigator skills to second-year medical students.
The students assist patients at the Arthritis Clinic at University Hospital at Downstate. “Many of our patients have either low medical literacy or difficulty with English. Many of them are immigrants,” said Ellen M. Ginzler, MD, MPH, SUNY Downstate’s professor emerita and former vice-chair for research and rheumatology division chief.
Dr. Ginzler sought out navigator candidates who showed a strong interest in working with underserved patients with complicated, severe disease who struggled with keeping appointments or adhering to medication regimens. The program also gave preference to students fluent in other languages such as Spanish.
All these efforts have generated improvements in care.
Assessing the program’s effectiveness in a cross-sectional study, Dr. Ginzler and colleagues reported that 94% of navigators were able to schedule appointments and 87% assisted with prescriptions. Navigators also had high success rates in answering medical questions, getting in touch with a patient’s doctor, and reminding patients of medical appointments.
Medical student Jeremy Wilson, a coauthor of the study, served as a navigator for a woman with lupus and scleroderma for many years, along with other comorbidities.
Mr. Wilson went above and beyond for this patient, helping to secure social services supports that included accompanying her to clinic visits and serving as her advocate. “She found an enormous difference in how she was treated when she went to these clinics because the doctors in those clinics took her much more seriously,” Dr. Ginzler said. Mr. Wilson ran interference to secure clinic appointments and worked with the patient’s rheumatology fellow in the clinic to get approval for medications.
Mr. Wilson and the patient formed a great bond. “It not only helped the patient, but it helped Jeremy tremendously in terms of how he felt about his medical career,” Dr. Ginzler said.
The program has since expanded to include patients with other rheumatic diseases, such as rheumatoid arthritis and psoriatic arthritis, and also offers navigator services in dermatology.
A total of 21 students to date have completed the second year of the program. “We’ve just selected eight more,” Dr. Ginzler said. Some of the students continue to do the program in their third or even fourth year as they’re applying for residencies.
A student-run, unpublished survey of nine students in the SUNY program found that all nine reported high confidence in identifying social factors that impact patient health and well-being, compared with four who reported high confidence prior to starting the program. “Additionally, students reported increased confidence in providing comprehensive care in rheumatology and dermatology, and interdisciplinary collaboration,” study author Alejandra K. Moncayo, MPH, and colleagues wrote.
When Navigators Go Virtual
Remission Medical offers its navigator service through its own standalone virtual clinic.
Pain associated with rheumatologic conditions increases the urgency to see a doctor. The goal of the virtual RemissionNavigator program is to meet rheumatology patients where they live, to bridge care gaps and reduce wait times, said Mr. Wehman.
RemissionNavigator accomplishes this through video visits and unlimited texting to its network of board-certified rheumatologists or rheumatology-focused advanced practice providers. Experts can answer questions about why labs are ordered, why a patient may have received a certain diagnosis, or provide detailed explanations of a rheumatic condition.
“There are instances where improvement for the patient means waiting a couple days for us versus 45 days for their brick-and-mortar choice,” Mr. Wehman said.
The program currently has 36 subscribers to Remission’s services, which include navigation. “We have 15 providers in a blend of employed and contracted relationships with Remission,” Mr. Wehman said.
Even in its infancy, the navigator program has produced some success stories. “We had a patient tell us that thanks to us, he was seen faster, found relief immediately through our diagnosis and prescription of methotrexate, felt better at work, lost weight, and was happier in general,” Mr. Wehman said.
Another patient was making monthly, 90-minute trips to Richmond for infusion services. Through the virtual program’s assistance, she is now receiving care from home and can get her monthly infusions at a local clinic.
Ultimately, the goal is to help rheumatology move into an era of value-based care where the transition from fee-for-service to per patient will enable optimized care models and better accessibility, Mr. Wehman said. “It will not happen overnight, but every day we work toward this future.”
VA Targets Rheumatology Care
The Department of Veterans Affairs (VA) has also explored the use of navigator services in rheumatology, including virtual services.
VA uses an integrated, interdisciplinary model that manages each veteran’s individual healthcare needs through a coordinated effort among providers, nurses, social workers, pharmacists, and other health professionals, according to VA press secretary Terrence Hayes.
Care coordination may include supporting scheduling appointments, managing chronic conditions, and coordinating care across different medical departments. “This coordination is particularly important in managing complex rheumatologic conditions, where multiple providers may be involved,” Mr. Hayes said.
Additionally, VA has launched a national telerheumatology initiative to improve access to rheumatology providers in rural areas. The initiative will assist veterans in understanding the telehealth system, navigating appointments, and ensuring they have the necessary technology for virtual consultations.
“It will also facilitate communication between rheumatologists, primary care providers, and other specialists, ensuring that all team members are aligned in their approach to the veteran’s care,” Mr. Hayes said.
Who Will Take Advantage of New Codes?
Currently, Remission Medical operates on a cash-pay model, but the company intends to transition to insurance-based coverage in 2025.
Remission Medical also partners directly with preexisting healthcare systems and clinics such as Sentara Health and OrthoVirginia, where a PIN program, powered by Remission Medical’s virtual rheumatology network, may be explored as well.
The company offers its partners synchronous virtual visits and e-consults. It’s likely that these larger organizations will explore coverage for navigator services for Medicare and private insurance. “We can be there to support them as they decide to implement this,” Mr. Wehman said.
Taking advantage of CMS’s navigator PIN codes is an eventual goal. Remission Medical has not submitted the codes yet, “but we do intend to as we continue to grow our membership count,” Mr. Wehman said. “We hope to provide coverage for most of the US and submit the codes to reimbursement by early to mid-2025.”
In terms of reimbursement, the VA operates under a different payment model than Medicare or private insurance, focusing on providing integrated care within the VA system rather than reimbursing for specific services such as patient navigation.
While the SUNY clinic takes care of Medicare patients, it’s unlikely that the new CMS codes for navigators would apply to medical students. Students get paid a monthly stipend for doing navigator work. “There’s a policy about what students can get paid, and how many hours they can work,” Dr. Ginzler clarified.
The SUNY Downstate and Lupus Foundation navigator programs rely on grants to sustain their services. Aurinia Pharmaceuticals has funded both programs, and the SUNY program received an additional grant from Janssen to expand its offerings.
Because it’s grant funded, the navigator position at the Lupus Foundation does not bill patient insurance, Ms. Costillo explained.
Navigator Work Requires Training
Before they start working with patients, navigators often go through a vetting or training process. At Remission Medical, a clinical leadership team does a synchronous interview, background check, and CV review of its potential navigators.
Even before she became a navigator, Ms. Costillo had a strong baseline education in this work. She has a bachelor’s degree in social work and 15 years of experience in social services working with disabled, vulnerable, and underserved populations. Some of her fellow navigators at the Lupus Foundation of America also have degrees in social work.
Ms. Costillo underwent training with the Patient-Centered Education & Research Institute to become a certified professional patient navigator. Her name is on the national registry. The curriculum covered various aspects of medical care such as patient and care team interactions and communications, health and clinical knowledge, patient care coordination and resources, and using evidence-based approaches.
“For our lupus patients, it is essential that navigators understand the disease and the impact on patients and families, treatments available and those in the pipelines, and also the ins and outs of various insurance options,” Ms. Costillo said.
Mr. Wehman, Dr. Williams, and Ms. Costillo reported no disclosures. Dr. Ginzler has been a consultant for Aurinia Pharmaceuticals.
A version of this article first appeared on Medscape.com.
When a large rheumatology clinic in Richmond, Virginia, heard that Medicare would be reimbursing patient navigators, they decided to launch their own virtual navigator program.
“We read about it and felt like it was the perfect representation of what we were already trying to do,” said Blake Wehman, founder and CEO of Remission Medical, which offers virtual diagnosis and longitudinal care in rheumatology.
Mr. Wehman has plans to start submitting for these principal illness navigation (PIN) codes in 2025.
The Centers for Medicare & Medicaid Services (CMS) in 2024 began paying navigators who assist Medicare patients with high-risk conditions, which could include rheumatologic diseases. “The codes are not limited to a specific set of diagnoses; rather, the definition of a serious, high-risk condition is dependent on clinical judgment,” the agency clarified.
CMS established this provision in the CY 2024 Physician Fee Schedule final rule.
Reimbursing patient navigators is long overdue, noted Edith Williams, PhD, MS, director of the Center for Community Health and Prevention and founding director of the Office of Health Equity Research at the University of Rochester in New York. “It’s something our patients need. It’s something that the science is telling us can impact outcomes as an adjunct to clinical care,” she said.
Dr. Williams said the new CMS codes “got our departments talking about what this policy is and how it would translate into patient care.”
The codes apply when navigators are assigned to support patients with high-risk conditions who need assistance connecting with clinical and other resources, including any unmet social determinants of health needs, or in diagnosis or treatment of their medical problems.
“Having a navigator by their side to help get through all the clinical and administrative challenges gives people an advocate and a partner who is with them and their families every step of the way to help make the journey easier,” said a CMS spokesperson.
Not all navigator programs may qualify for the new codes. Some are supported by grants and don’t bill patient insurance. However, they all share a common goal: to guide patients through the healthcare continuum and assist with appointments and medication adherence.
Identifying ‘Root Causes’ of Barriers
Navigators represent a wide variety of backgrounds, ranging from healthcare professionals to students or even patients themselves. They generally don’t provide medical advice. “However, we are responsible for making sure our patients and their families are educated and aware, then assist with guidance on their path,” said Katie Costillo, BSW, CPPN, patient navigator and program manager with the Lupus Foundation of America, Heartland Region.
“Training and experience in engaging and building rapport is essential to assisting patients overcome obstacles that limit their access to healthcare,” she said. Narrowing down with patients the root causes of their barriers and then identifying appropriate and available community resources is key.
Studies have demonstrated the effectiveness of adding a navigator to a rheumatology patient’s care plan. In one study, a group of Boston researchers determined that navigators played a useful role in reducing adherence barriers to oral disease-modifying antirheumatic drugs. The navigators uncovered several concerns among 107 rheumatology patients, including fear of adverse events and medication effectiveness.
They also helped to facilitate patient-physician communication, developed strategies to improve medication adherence, and provided medication and diagnosis education. Patients reported satisfaction with the navigator experience.
A study Dr. Williams coauthored that examined behavioral interventions to support African American women with systemic lupus erythematosus found that patient navigator participants had superior coping scores, compared with those engaged in peer-to-peer methodology and patient support groups.
“We had a lot of success with the mentorship program, too,” Dr. Williams said. Navigator services, however, offer more one-on-one attention, “and it’s more tailored to what the person needs rather than the set curriculum that the mentors delivered to their mentees.”
Supporting Patients With Lupus
Ideally, navigators should be able to relate to patients and know what they’re going through, Dr. Williams said. This is someone whom the patient can trust and depend on. “That’s where the benefit of having someone who is also a patient lies because they’re ultimately relatable to other patients. But different institutions have taken different approaches to this.”
Some programs focus on specific rheumatologic conditions. The Lupus Foundation of America, for example, established patient navigator programs to assist patients with lupus in four markets across the country.
The Heartland patient navigator program is available for all patients with lupus within its region, which includes Kansas, Missouri, and central and southern Illinois. As a navigator, Ms. Costillo has been assisting patients since 2022. In 2023, she began meeting with patients at the Washington University Lupus Clinic (WULC) in St. Louis, Missouri.
Navigators work directly with patients before and after their appointment to ensure follow-up and reduce missed appointments. “They help lupus patients connect with community services and overcoming barriers to access and care. The goal of this position is to improve overall disease management, which results in better health outcomes,” Ms. Costillo said.
Since its inception, the patient navigator program at WULC has shown a decrease in patient no-call no-shows and an increase in requests to reschedule as opposed to not showing up for their scheduled appointment, based on history.
Patients have reported fewer barriers to transportation and improvement in access to resources, support, and disease education. “Our patients have also stated [that] meeting with the navigator during their appointments has helped them to feel heard, understood, and supported,” Ms. Costillo said.
Navigator Work Is Not Without Challenges
A total of 90% of patients with lupus are women, and women of color are two to three times more likely to develop lupus in their lifetime.
“Based on socioeconomic statistics, lupus patients are in a demographic that is commonly underserved, underfunded, and often overlooked. Finding appropriate local community resources for a patient who must choose between feeding her family or paying for transportation to multiple physician appointments is a common problem,” Ms. Costillo said.
Much of the assistance that became available during the COVID pandemic is starting to disappear. “With the rising costs of daily living, we are having to find creative and alternative ways to break down barriers and find support to fill those gaps,” she continued.
Getting insurance coverage of patients is another challenge. Many patients with lupus will be prescribed a treatment that insurance refuses to cover even after the physician disputes it.
Additionally, many patients with lupus are unable to work to support their family. A majority who apply for Social Security Disability Insurance are denied on their first and second attempts, “requiring multiple hearings and pages of documentation from their physicians,” Ms. Costillo said.
Students Serve as Navigators
One inner-city program is seeking to increase access to healthcare services to patients with lupus and lupus nephritis in underserved communities. In 2021, SUNY Downstate Health Sciences University in New York City, in partnership with the Brooklyn Free Clinic and Brooklyn Health Disparities Center, launched a program to teach navigator skills to second-year medical students.
The students assist patients at the Arthritis Clinic at University Hospital at Downstate. “Many of our patients have either low medical literacy or difficulty with English. Many of them are immigrants,” said Ellen M. Ginzler, MD, MPH, SUNY Downstate’s professor emerita and former vice-chair for research and rheumatology division chief.
Dr. Ginzler sought out navigator candidates who showed a strong interest in working with underserved patients with complicated, severe disease who struggled with keeping appointments or adhering to medication regimens. The program also gave preference to students fluent in other languages such as Spanish.
All these efforts have generated improvements in care.
Assessing the program’s effectiveness in a cross-sectional study, Dr. Ginzler and colleagues reported that 94% of navigators were able to schedule appointments and 87% assisted with prescriptions. Navigators also had high success rates in answering medical questions, getting in touch with a patient’s doctor, and reminding patients of medical appointments.
Medical student Jeremy Wilson, a coauthor of the study, served as a navigator for a woman with lupus and scleroderma for many years, along with other comorbidities.
Mr. Wilson went above and beyond for this patient, helping to secure social services supports that included accompanying her to clinic visits and serving as her advocate. “She found an enormous difference in how she was treated when she went to these clinics because the doctors in those clinics took her much more seriously,” Dr. Ginzler said. Mr. Wilson ran interference to secure clinic appointments and worked with the patient’s rheumatology fellow in the clinic to get approval for medications.
Mr. Wilson and the patient formed a great bond. “It not only helped the patient, but it helped Jeremy tremendously in terms of how he felt about his medical career,” Dr. Ginzler said.
The program has since expanded to include patients with other rheumatic diseases, such as rheumatoid arthritis and psoriatic arthritis, and also offers navigator services in dermatology.
A total of 21 students to date have completed the second year of the program. “We’ve just selected eight more,” Dr. Ginzler said. Some of the students continue to do the program in their third or even fourth year as they’re applying for residencies.
A student-run, unpublished survey of nine students in the SUNY program found that all nine reported high confidence in identifying social factors that impact patient health and well-being, compared with four who reported high confidence prior to starting the program. “Additionally, students reported increased confidence in providing comprehensive care in rheumatology and dermatology, and interdisciplinary collaboration,” study author Alejandra K. Moncayo, MPH, and colleagues wrote.
When Navigators Go Virtual
Remission Medical offers its navigator service through its own standalone virtual clinic.
Pain associated with rheumatologic conditions increases the urgency to see a doctor. The goal of the virtual RemissionNavigator program is to meet rheumatology patients where they live, to bridge care gaps and reduce wait times, said Mr. Wehman.
RemissionNavigator accomplishes this through video visits and unlimited texting to its network of board-certified rheumatologists or rheumatology-focused advanced practice providers. Experts can answer questions about why labs are ordered, why a patient may have received a certain diagnosis, or provide detailed explanations of a rheumatic condition.
“There are instances where improvement for the patient means waiting a couple days for us versus 45 days for their brick-and-mortar choice,” Mr. Wehman said.
The program currently has 36 subscribers to Remission’s services, which include navigation. “We have 15 providers in a blend of employed and contracted relationships with Remission,” Mr. Wehman said.
Even in its infancy, the navigator program has produced some success stories. “We had a patient tell us that thanks to us, he was seen faster, found relief immediately through our diagnosis and prescription of methotrexate, felt better at work, lost weight, and was happier in general,” Mr. Wehman said.
Another patient was making monthly, 90-minute trips to Richmond for infusion services. Through the virtual program’s assistance, she is now receiving care from home and can get her monthly infusions at a local clinic.
Ultimately, the goal is to help rheumatology move into an era of value-based care where the transition from fee-for-service to per patient will enable optimized care models and better accessibility, Mr. Wehman said. “It will not happen overnight, but every day we work toward this future.”
VA Targets Rheumatology Care
The Department of Veterans Affairs (VA) has also explored the use of navigator services in rheumatology, including virtual services.
VA uses an integrated, interdisciplinary model that manages each veteran’s individual healthcare needs through a coordinated effort among providers, nurses, social workers, pharmacists, and other health professionals, according to VA press secretary Terrence Hayes.
Care coordination may include supporting scheduling appointments, managing chronic conditions, and coordinating care across different medical departments. “This coordination is particularly important in managing complex rheumatologic conditions, where multiple providers may be involved,” Mr. Hayes said.
Additionally, VA has launched a national telerheumatology initiative to improve access to rheumatology providers in rural areas. The initiative will assist veterans in understanding the telehealth system, navigating appointments, and ensuring they have the necessary technology for virtual consultations.
“It will also facilitate communication between rheumatologists, primary care providers, and other specialists, ensuring that all team members are aligned in their approach to the veteran’s care,” Mr. Hayes said.
Who Will Take Advantage of New Codes?
Currently, Remission Medical operates on a cash-pay model, but the company intends to transition to insurance-based coverage in 2025.
Remission Medical also partners directly with preexisting healthcare systems and clinics such as Sentara Health and OrthoVirginia, where a PIN program, powered by Remission Medical’s virtual rheumatology network, may be explored as well.
The company offers its partners synchronous virtual visits and e-consults. It’s likely that these larger organizations will explore coverage for navigator services for Medicare and private insurance. “We can be there to support them as they decide to implement this,” Mr. Wehman said.
Taking advantage of CMS’s navigator PIN codes is an eventual goal. Remission Medical has not submitted the codes yet, “but we do intend to as we continue to grow our membership count,” Mr. Wehman said. “We hope to provide coverage for most of the US and submit the codes to reimbursement by early to mid-2025.”
In terms of reimbursement, the VA operates under a different payment model than Medicare or private insurance, focusing on providing integrated care within the VA system rather than reimbursing for specific services such as patient navigation.
While the SUNY clinic takes care of Medicare patients, it’s unlikely that the new CMS codes for navigators would apply to medical students. Students get paid a monthly stipend for doing navigator work. “There’s a policy about what students can get paid, and how many hours they can work,” Dr. Ginzler clarified.
The SUNY Downstate and Lupus Foundation navigator programs rely on grants to sustain their services. Aurinia Pharmaceuticals has funded both programs, and the SUNY program received an additional grant from Janssen to expand its offerings.
Because it’s grant funded, the navigator position at the Lupus Foundation does not bill patient insurance, Ms. Costillo explained.
Navigator Work Requires Training
Before they start working with patients, navigators often go through a vetting or training process. At Remission Medical, a clinical leadership team does a synchronous interview, background check, and CV review of its potential navigators.
Even before she became a navigator, Ms. Costillo had a strong baseline education in this work. She has a bachelor’s degree in social work and 15 years of experience in social services working with disabled, vulnerable, and underserved populations. Some of her fellow navigators at the Lupus Foundation of America also have degrees in social work.
Ms. Costillo underwent training with the Patient-Centered Education & Research Institute to become a certified professional patient navigator. Her name is on the national registry. The curriculum covered various aspects of medical care such as patient and care team interactions and communications, health and clinical knowledge, patient care coordination and resources, and using evidence-based approaches.
“For our lupus patients, it is essential that navigators understand the disease and the impact on patients and families, treatments available and those in the pipelines, and also the ins and outs of various insurance options,” Ms. Costillo said.
Mr. Wehman, Dr. Williams, and Ms. Costillo reported no disclosures. Dr. Ginzler has been a consultant for Aurinia Pharmaceuticals.
A version of this article first appeared on Medscape.com.
When a large rheumatology clinic in Richmond, Virginia, heard that Medicare would be reimbursing patient navigators, they decided to launch their own virtual navigator program.
“We read about it and felt like it was the perfect representation of what we were already trying to do,” said Blake Wehman, founder and CEO of Remission Medical, which offers virtual diagnosis and longitudinal care in rheumatology.
Mr. Wehman has plans to start submitting for these principal illness navigation (PIN) codes in 2025.
The Centers for Medicare & Medicaid Services (CMS) in 2024 began paying navigators who assist Medicare patients with high-risk conditions, which could include rheumatologic diseases. “The codes are not limited to a specific set of diagnoses; rather, the definition of a serious, high-risk condition is dependent on clinical judgment,” the agency clarified.
CMS established this provision in the CY 2024 Physician Fee Schedule final rule.
Reimbursing patient navigators is long overdue, noted Edith Williams, PhD, MS, director of the Center for Community Health and Prevention and founding director of the Office of Health Equity Research at the University of Rochester in New York. “It’s something our patients need. It’s something that the science is telling us can impact outcomes as an adjunct to clinical care,” she said.
Dr. Williams said the new CMS codes “got our departments talking about what this policy is and how it would translate into patient care.”
The codes apply when navigators are assigned to support patients with high-risk conditions who need assistance connecting with clinical and other resources, including any unmet social determinants of health needs, or in diagnosis or treatment of their medical problems.
“Having a navigator by their side to help get through all the clinical and administrative challenges gives people an advocate and a partner who is with them and their families every step of the way to help make the journey easier,” said a CMS spokesperson.
Not all navigator programs may qualify for the new codes. Some are supported by grants and don’t bill patient insurance. However, they all share a common goal: to guide patients through the healthcare continuum and assist with appointments and medication adherence.
Identifying ‘Root Causes’ of Barriers
Navigators represent a wide variety of backgrounds, ranging from healthcare professionals to students or even patients themselves. They generally don’t provide medical advice. “However, we are responsible for making sure our patients and their families are educated and aware, then assist with guidance on their path,” said Katie Costillo, BSW, CPPN, patient navigator and program manager with the Lupus Foundation of America, Heartland Region.
“Training and experience in engaging and building rapport is essential to assisting patients overcome obstacles that limit their access to healthcare,” she said. Narrowing down with patients the root causes of their barriers and then identifying appropriate and available community resources is key.
Studies have demonstrated the effectiveness of adding a navigator to a rheumatology patient’s care plan. In one study, a group of Boston researchers determined that navigators played a useful role in reducing adherence barriers to oral disease-modifying antirheumatic drugs. The navigators uncovered several concerns among 107 rheumatology patients, including fear of adverse events and medication effectiveness.
They also helped to facilitate patient-physician communication, developed strategies to improve medication adherence, and provided medication and diagnosis education. Patients reported satisfaction with the navigator experience.
A study Dr. Williams coauthored that examined behavioral interventions to support African American women with systemic lupus erythematosus found that patient navigator participants had superior coping scores, compared with those engaged in peer-to-peer methodology and patient support groups.
“We had a lot of success with the mentorship program, too,” Dr. Williams said. Navigator services, however, offer more one-on-one attention, “and it’s more tailored to what the person needs rather than the set curriculum that the mentors delivered to their mentees.”
Supporting Patients With Lupus
Ideally, navigators should be able to relate to patients and know what they’re going through, Dr. Williams said. This is someone whom the patient can trust and depend on. “That’s where the benefit of having someone who is also a patient lies because they’re ultimately relatable to other patients. But different institutions have taken different approaches to this.”
Some programs focus on specific rheumatologic conditions. The Lupus Foundation of America, for example, established patient navigator programs to assist patients with lupus in four markets across the country.
The Heartland patient navigator program is available for all patients with lupus within its region, which includes Kansas, Missouri, and central and southern Illinois. As a navigator, Ms. Costillo has been assisting patients since 2022. In 2023, she began meeting with patients at the Washington University Lupus Clinic (WULC) in St. Louis, Missouri.
Navigators work directly with patients before and after their appointment to ensure follow-up and reduce missed appointments. “They help lupus patients connect with community services and overcoming barriers to access and care. The goal of this position is to improve overall disease management, which results in better health outcomes,” Ms. Costillo said.
Since its inception, the patient navigator program at WULC has shown a decrease in patient no-call no-shows and an increase in requests to reschedule as opposed to not showing up for their scheduled appointment, based on history.
Patients have reported fewer barriers to transportation and improvement in access to resources, support, and disease education. “Our patients have also stated [that] meeting with the navigator during their appointments has helped them to feel heard, understood, and supported,” Ms. Costillo said.
Navigator Work Is Not Without Challenges
A total of 90% of patients with lupus are women, and women of color are two to three times more likely to develop lupus in their lifetime.
“Based on socioeconomic statistics, lupus patients are in a demographic that is commonly underserved, underfunded, and often overlooked. Finding appropriate local community resources for a patient who must choose between feeding her family or paying for transportation to multiple physician appointments is a common problem,” Ms. Costillo said.
Much of the assistance that became available during the COVID pandemic is starting to disappear. “With the rising costs of daily living, we are having to find creative and alternative ways to break down barriers and find support to fill those gaps,” she continued.
Getting insurance coverage of patients is another challenge. Many patients with lupus will be prescribed a treatment that insurance refuses to cover even after the physician disputes it.
Additionally, many patients with lupus are unable to work to support their family. A majority who apply for Social Security Disability Insurance are denied on their first and second attempts, “requiring multiple hearings and pages of documentation from their physicians,” Ms. Costillo said.
Students Serve as Navigators
One inner-city program is seeking to increase access to healthcare services to patients with lupus and lupus nephritis in underserved communities. In 2021, SUNY Downstate Health Sciences University in New York City, in partnership with the Brooklyn Free Clinic and Brooklyn Health Disparities Center, launched a program to teach navigator skills to second-year medical students.
The students assist patients at the Arthritis Clinic at University Hospital at Downstate. “Many of our patients have either low medical literacy or difficulty with English. Many of them are immigrants,” said Ellen M. Ginzler, MD, MPH, SUNY Downstate’s professor emerita and former vice-chair for research and rheumatology division chief.
Dr. Ginzler sought out navigator candidates who showed a strong interest in working with underserved patients with complicated, severe disease who struggled with keeping appointments or adhering to medication regimens. The program also gave preference to students fluent in other languages such as Spanish.
All these efforts have generated improvements in care.
Assessing the program’s effectiveness in a cross-sectional study, Dr. Ginzler and colleagues reported that 94% of navigators were able to schedule appointments and 87% assisted with prescriptions. Navigators also had high success rates in answering medical questions, getting in touch with a patient’s doctor, and reminding patients of medical appointments.
Medical student Jeremy Wilson, a coauthor of the study, served as a navigator for a woman with lupus and scleroderma for many years, along with other comorbidities.
Mr. Wilson went above and beyond for this patient, helping to secure social services supports that included accompanying her to clinic visits and serving as her advocate. “She found an enormous difference in how she was treated when she went to these clinics because the doctors in those clinics took her much more seriously,” Dr. Ginzler said. Mr. Wilson ran interference to secure clinic appointments and worked with the patient’s rheumatology fellow in the clinic to get approval for medications.
Mr. Wilson and the patient formed a great bond. “It not only helped the patient, but it helped Jeremy tremendously in terms of how he felt about his medical career,” Dr. Ginzler said.
The program has since expanded to include patients with other rheumatic diseases, such as rheumatoid arthritis and psoriatic arthritis, and also offers navigator services in dermatology.
A total of 21 students to date have completed the second year of the program. “We’ve just selected eight more,” Dr. Ginzler said. Some of the students continue to do the program in their third or even fourth year as they’re applying for residencies.
A student-run, unpublished survey of nine students in the SUNY program found that all nine reported high confidence in identifying social factors that impact patient health and well-being, compared with four who reported high confidence prior to starting the program. “Additionally, students reported increased confidence in providing comprehensive care in rheumatology and dermatology, and interdisciplinary collaboration,” study author Alejandra K. Moncayo, MPH, and colleagues wrote.
When Navigators Go Virtual
Remission Medical offers its navigator service through its own standalone virtual clinic.
Pain associated with rheumatologic conditions increases the urgency to see a doctor. The goal of the virtual RemissionNavigator program is to meet rheumatology patients where they live, to bridge care gaps and reduce wait times, said Mr. Wehman.
RemissionNavigator accomplishes this through video visits and unlimited texting to its network of board-certified rheumatologists or rheumatology-focused advanced practice providers. Experts can answer questions about why labs are ordered, why a patient may have received a certain diagnosis, or provide detailed explanations of a rheumatic condition.
“There are instances where improvement for the patient means waiting a couple days for us versus 45 days for their brick-and-mortar choice,” Mr. Wehman said.
The program currently has 36 subscribers to Remission’s services, which include navigation. “We have 15 providers in a blend of employed and contracted relationships with Remission,” Mr. Wehman said.
Even in its infancy, the navigator program has produced some success stories. “We had a patient tell us that thanks to us, he was seen faster, found relief immediately through our diagnosis and prescription of methotrexate, felt better at work, lost weight, and was happier in general,” Mr. Wehman said.
Another patient was making monthly, 90-minute trips to Richmond for infusion services. Through the virtual program’s assistance, she is now receiving care from home and can get her monthly infusions at a local clinic.
Ultimately, the goal is to help rheumatology move into an era of value-based care where the transition from fee-for-service to per patient will enable optimized care models and better accessibility, Mr. Wehman said. “It will not happen overnight, but every day we work toward this future.”
VA Targets Rheumatology Care
The Department of Veterans Affairs (VA) has also explored the use of navigator services in rheumatology, including virtual services.
VA uses an integrated, interdisciplinary model that manages each veteran’s individual healthcare needs through a coordinated effort among providers, nurses, social workers, pharmacists, and other health professionals, according to VA press secretary Terrence Hayes.
Care coordination may include supporting scheduling appointments, managing chronic conditions, and coordinating care across different medical departments. “This coordination is particularly important in managing complex rheumatologic conditions, where multiple providers may be involved,” Mr. Hayes said.
Additionally, VA has launched a national telerheumatology initiative to improve access to rheumatology providers in rural areas. The initiative will assist veterans in understanding the telehealth system, navigating appointments, and ensuring they have the necessary technology for virtual consultations.
“It will also facilitate communication between rheumatologists, primary care providers, and other specialists, ensuring that all team members are aligned in their approach to the veteran’s care,” Mr. Hayes said.
Who Will Take Advantage of New Codes?
Currently, Remission Medical operates on a cash-pay model, but the company intends to transition to insurance-based coverage in 2025.
Remission Medical also partners directly with preexisting healthcare systems and clinics such as Sentara Health and OrthoVirginia, where a PIN program, powered by Remission Medical’s virtual rheumatology network, may be explored as well.
The company offers its partners synchronous virtual visits and e-consults. It’s likely that these larger organizations will explore coverage for navigator services for Medicare and private insurance. “We can be there to support them as they decide to implement this,” Mr. Wehman said.
Taking advantage of CMS’s navigator PIN codes is an eventual goal. Remission Medical has not submitted the codes yet, “but we do intend to as we continue to grow our membership count,” Mr. Wehman said. “We hope to provide coverage for most of the US and submit the codes to reimbursement by early to mid-2025.”
In terms of reimbursement, the VA operates under a different payment model than Medicare or private insurance, focusing on providing integrated care within the VA system rather than reimbursing for specific services such as patient navigation.
While the SUNY clinic takes care of Medicare patients, it’s unlikely that the new CMS codes for navigators would apply to medical students. Students get paid a monthly stipend for doing navigator work. “There’s a policy about what students can get paid, and how many hours they can work,” Dr. Ginzler clarified.
The SUNY Downstate and Lupus Foundation navigator programs rely on grants to sustain their services. Aurinia Pharmaceuticals has funded both programs, and the SUNY program received an additional grant from Janssen to expand its offerings.
Because it’s grant funded, the navigator position at the Lupus Foundation does not bill patient insurance, Ms. Costillo explained.
Navigator Work Requires Training
Before they start working with patients, navigators often go through a vetting or training process. At Remission Medical, a clinical leadership team does a synchronous interview, background check, and CV review of its potential navigators.
Even before she became a navigator, Ms. Costillo had a strong baseline education in this work. She has a bachelor’s degree in social work and 15 years of experience in social services working with disabled, vulnerable, and underserved populations. Some of her fellow navigators at the Lupus Foundation of America also have degrees in social work.
Ms. Costillo underwent training with the Patient-Centered Education & Research Institute to become a certified professional patient navigator. Her name is on the national registry. The curriculum covered various aspects of medical care such as patient and care team interactions and communications, health and clinical knowledge, patient care coordination and resources, and using evidence-based approaches.
“For our lupus patients, it is essential that navigators understand the disease and the impact on patients and families, treatments available and those in the pipelines, and also the ins and outs of various insurance options,” Ms. Costillo said.
Mr. Wehman, Dr. Williams, and Ms. Costillo reported no disclosures. Dr. Ginzler has been a consultant for Aurinia Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Trial Looks at Early Use of Mycophenolate to Reduce Flares, Nephritis
Early use of mycophenolate mofetil (MMF), a drug used to dampen the immune system in organ transplant recipients, may reduce the risk for severe flares in patients with newly diagnosed systemic lupus erythematosus (SLE), according to results from a randomized, open-label, observer-blinded clinical trial.
In interviews, two SLE specialists who were not involved with the study said the research is preliminary but promising. However, another specialist criticized the paper’s reliance on unusual doses of prednisone and MMF, saying it “puts people on a treatment regimen that nobody ever uses.”
The Lupus Foundation of America estimates that about 16,000 people in the United States are diagnosed with lupus each year. “Our current treatment paradigm is to go pretty slowly and start treatment for new-onset, mild SLE with glucocorticoids, if necessary, and hydroxychloroquine,” said Karen H. Costenbader, MD, MPH, of Harvard Medical School and Harvard School of Public Health, Boston, Massachusetts.
Stronger immunosuppressive agents may be added as patients progress, she said.
Off-label use of MMF, which is approved by the Food and Drug Administration only for patients with certain organ transplants, may be appropriate in some cases, she said. “There is a big push to start immunosuppressives earlier, but we currently would reserve mycophenolate for those with severe manifestations — lupus nephritis; vasculitis; or lung, brain, or heart inflammation.”
In the trial, adult patients who received oral prednisone (starting at 0.5 mg/kg per day) and hydroxychloroquine sulfate (5 mg/kg per day) plus MMF (500 mg twice daily) for 96 weeks were less likely to develop severe flares than those who took the regimen without MMF (relative risk [RR], 0.39; 95% CI, 0.17-0.87; P = .01). Severe flares occurred in 10.8% of the MMF group (7 of 65 patients) and in 27.7% of the control group (18 of 65), Yijun You, MD, of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues reported in JAMA Network Open.
Patients in the MMF group also had 89% lower risk for lupus nephritis than those in the control group (RR, 0.11; 95% CI, 0.01-0.85; P = .008), with kidney involvement occurring in 1.5% (1 of 65) vs 13.8% (9 of 65).
During 2018-2021, researchers recruited 130 patients in China aged 18-65 years with newly diagnosed SLE, a high titer of anti–double-stranded DNA (dsDNA) antibodies, and no major organ involvement (mean age, 34.5 years; 86.2% women). Patients’ initial 0.5–mg/kg per day prednisone dose was maintained for 4 weeks, then tapered by 5.0 mg every 2 weeks, and when the dose had been reduced to 20.0 mg/day, it was tapered by 5 mg every month and then gradually to 0.1-0.2 mg/kg per day. If patients had severe flares, they stopped taking MMF. (The study authors did not respond to requests for comment on the study.)
‘A Treatment Regimen That Nobody Ever Uses’
While Dr. Costenbader called the study “very interesting” and said “every person diagnosing or taking care of patients with lupus should be familiar” with it, she noted that the prednisone doses were high. “I am wondering why they used quite so much glucocorticoid for everyone. This may have masked some of the MMF effect and biased toward the null. They also used a low dose of MMF and did not ramp it up as we would normally to a full dose. That being said, it is remarkable that it was well-tolerated and resulted in better outcomes over the period of the trial.”
Daniel J. Wallace, MD, of Cedars-Sinai Medical Center, Los Angeles, California, and the University of California, Los Angeles, also highlighted the high doses of prednisone and low doses of MMF. “It’s a useless paper that puts people on a treatment regimen that nobody ever uses,” he said.
The rates of mild to moderate flares were similar between the control and intervention groups (38.5% vs 36.9%, respectively; RR, 0.96; P = .90). This finding is surprising, said Judith A. James, MD, PhD, executive vice president, chief medical officer, and head of the rheumatology clinic and Arthritis and Clinical Immunology Research Program at the Oklahoma Medical Research Foundation in Oklahoma City and also the Associate Vice Provost of Clinical & Translational Science, professor of medicine, and George Lynn Cross Research Professor at the University of Oklahoma Health Sciences Center in Oklahoma City. “It may be that mild flares have a different mechanism or are caused by noninflammatory endotypes that don’t respond to MMF.”
Dr. Costenbader noted that a risk-benefit analysis will need to be done to take the risks of MMF into account. “However, every time that a person flares or is not in lupus low-disease activity state, potentially permanent organ damage is done and the patient suffers,” she said. “Preventing lupus nephritis de novo was also seen — nine cases potentially prevented — and that is also really interesting. It would be amazing if we could completely avoid that life-threatening complication.”
MMF can cause miscarriage and boost the risk for birth defects, and the manufacturer says it can lower the effectiveness of birth control pills. It can also boost the risk for some cancers such as lymphoma and increase the risk for infections.
Surprisingly, the number of adverse events in the control and intervention groups were similar (35.4% vs 46.2%, respectively; RR, 1.30; 95% CI, 0.86-1.99; P = .20). They included infection (30.8% vs 33.8%, respectively; P = .70) and gastrointestinal tract events (16.9% for both; P > .99).
“There were overall pretty similar rates of side effects, but maybe this was because MMF dose was pretty low in the treated group, or the glucocorticoid dose was not so low in both groups,” Dr. Costenbader said. She also noted that “the risk of malignancy with MMF is longer term than this study. It may not show up for 5-10 or even more years, but we know it exists. Infections are also increased with MMF — some of which can be avoided with vaccines for COVID, pneumonia, influenza, shingles, etc. MMF also causes gastrointestinal intolerance, and people often are not able to take it because of nausea, vomiting, diarrhea, and elevated liver function tests.”
Dr. James said the infection rates “may be due to the higher doses of steroids patients in both groups are on for several months at the beginning of the study.”
A total of 12 patients in the MMF group discontinued the intervention for various reasons, and 6 were lost to follow-up. In the control group, 20 discontinued the intervention and two were lost to follow-up. However, all 130 patients in the trial were included in the primary and secondary outcome analyses.
Should clinicians consider prescribing MMF to patients with new-onset SLE? “We usually wait until later when there are indications of more severe disease, but here they started it from the time of diagnosis if the patient was anti-dsDNA positive. Given insurance restrictions in this country, we would be unlikely to be able to do that for many patients,” Dr. Costenbader said. “They likely also overtreated a lot of patients who didn’t need it. Due to our lack of more specific biomarkers and precision medicine for lupus, we do currently undertreat a lot of patients, as this study highlights, as well as overtreat others.”
How Much Might Cost Factor Into Treatment Decisions?
The study did not examine cost. Prednisone and hydroxychloroquine sulfate are inexpensive, but Dr. James said MMF can cost about $450 a month at the study dosage. However, “the average hospitalization without an ICU [intensive care unit] visit for an SLE patient is about $15,000-$20,000. If you can avoid one hospitalization, you can pay for nearly 4 years of MMF. More importantly, from a financial perspective, if you can convert a severe lupus patient to a mild/moderate lupus patient, then the annual costs of lupus decrease nearly by half, from about $52,000 per year to $25,000 per year.”
The study authors noted various limitations such as the small number of subjects, the need for a longer trial “to determine the advantages and disadvantages of early application of MMF,” and the fact that all subjects were Asian. The authors also called for confirmation via a double-blind, placebo-controlled study.
The study was funded by grants to the authors by the National Natural Science Foundation of China, Shanghai Rising-Star Program, Natural Science Foundation of Shanghai, Five-Year National Key R&D Program, and Ruijin–Zhongmei Huadong Lupus Funding. The authors had no disclosures. Dr. Costenbader disclosed consulting/research collaboration relationships with AstraZeneca, Amgen, Biogen, Bristol-Myers Squibb, GSK, Merck, Gilead, and Cabaletta. Dr. James and Dr. Wallace had no disclosures.
A version of this article first appeared on Medscape.com.
Early use of mycophenolate mofetil (MMF), a drug used to dampen the immune system in organ transplant recipients, may reduce the risk for severe flares in patients with newly diagnosed systemic lupus erythematosus (SLE), according to results from a randomized, open-label, observer-blinded clinical trial.
In interviews, two SLE specialists who were not involved with the study said the research is preliminary but promising. However, another specialist criticized the paper’s reliance on unusual doses of prednisone and MMF, saying it “puts people on a treatment regimen that nobody ever uses.”
The Lupus Foundation of America estimates that about 16,000 people in the United States are diagnosed with lupus each year. “Our current treatment paradigm is to go pretty slowly and start treatment for new-onset, mild SLE with glucocorticoids, if necessary, and hydroxychloroquine,” said Karen H. Costenbader, MD, MPH, of Harvard Medical School and Harvard School of Public Health, Boston, Massachusetts.
Stronger immunosuppressive agents may be added as patients progress, she said.
Off-label use of MMF, which is approved by the Food and Drug Administration only for patients with certain organ transplants, may be appropriate in some cases, she said. “There is a big push to start immunosuppressives earlier, but we currently would reserve mycophenolate for those with severe manifestations — lupus nephritis; vasculitis; or lung, brain, or heart inflammation.”
In the trial, adult patients who received oral prednisone (starting at 0.5 mg/kg per day) and hydroxychloroquine sulfate (5 mg/kg per day) plus MMF (500 mg twice daily) for 96 weeks were less likely to develop severe flares than those who took the regimen without MMF (relative risk [RR], 0.39; 95% CI, 0.17-0.87; P = .01). Severe flares occurred in 10.8% of the MMF group (7 of 65 patients) and in 27.7% of the control group (18 of 65), Yijun You, MD, of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues reported in JAMA Network Open.
Patients in the MMF group also had 89% lower risk for lupus nephritis than those in the control group (RR, 0.11; 95% CI, 0.01-0.85; P = .008), with kidney involvement occurring in 1.5% (1 of 65) vs 13.8% (9 of 65).
During 2018-2021, researchers recruited 130 patients in China aged 18-65 years with newly diagnosed SLE, a high titer of anti–double-stranded DNA (dsDNA) antibodies, and no major organ involvement (mean age, 34.5 years; 86.2% women). Patients’ initial 0.5–mg/kg per day prednisone dose was maintained for 4 weeks, then tapered by 5.0 mg every 2 weeks, and when the dose had been reduced to 20.0 mg/day, it was tapered by 5 mg every month and then gradually to 0.1-0.2 mg/kg per day. If patients had severe flares, they stopped taking MMF. (The study authors did not respond to requests for comment on the study.)
‘A Treatment Regimen That Nobody Ever Uses’
While Dr. Costenbader called the study “very interesting” and said “every person diagnosing or taking care of patients with lupus should be familiar” with it, she noted that the prednisone doses were high. “I am wondering why they used quite so much glucocorticoid for everyone. This may have masked some of the MMF effect and biased toward the null. They also used a low dose of MMF and did not ramp it up as we would normally to a full dose. That being said, it is remarkable that it was well-tolerated and resulted in better outcomes over the period of the trial.”
Daniel J. Wallace, MD, of Cedars-Sinai Medical Center, Los Angeles, California, and the University of California, Los Angeles, also highlighted the high doses of prednisone and low doses of MMF. “It’s a useless paper that puts people on a treatment regimen that nobody ever uses,” he said.
The rates of mild to moderate flares were similar between the control and intervention groups (38.5% vs 36.9%, respectively; RR, 0.96; P = .90). This finding is surprising, said Judith A. James, MD, PhD, executive vice president, chief medical officer, and head of the rheumatology clinic and Arthritis and Clinical Immunology Research Program at the Oklahoma Medical Research Foundation in Oklahoma City and also the Associate Vice Provost of Clinical & Translational Science, professor of medicine, and George Lynn Cross Research Professor at the University of Oklahoma Health Sciences Center in Oklahoma City. “It may be that mild flares have a different mechanism or are caused by noninflammatory endotypes that don’t respond to MMF.”
Dr. Costenbader noted that a risk-benefit analysis will need to be done to take the risks of MMF into account. “However, every time that a person flares or is not in lupus low-disease activity state, potentially permanent organ damage is done and the patient suffers,” she said. “Preventing lupus nephritis de novo was also seen — nine cases potentially prevented — and that is also really interesting. It would be amazing if we could completely avoid that life-threatening complication.”
MMF can cause miscarriage and boost the risk for birth defects, and the manufacturer says it can lower the effectiveness of birth control pills. It can also boost the risk for some cancers such as lymphoma and increase the risk for infections.
Surprisingly, the number of adverse events in the control and intervention groups were similar (35.4% vs 46.2%, respectively; RR, 1.30; 95% CI, 0.86-1.99; P = .20). They included infection (30.8% vs 33.8%, respectively; P = .70) and gastrointestinal tract events (16.9% for both; P > .99).
“There were overall pretty similar rates of side effects, but maybe this was because MMF dose was pretty low in the treated group, or the glucocorticoid dose was not so low in both groups,” Dr. Costenbader said. She also noted that “the risk of malignancy with MMF is longer term than this study. It may not show up for 5-10 or even more years, but we know it exists. Infections are also increased with MMF — some of which can be avoided with vaccines for COVID, pneumonia, influenza, shingles, etc. MMF also causes gastrointestinal intolerance, and people often are not able to take it because of nausea, vomiting, diarrhea, and elevated liver function tests.”
Dr. James said the infection rates “may be due to the higher doses of steroids patients in both groups are on for several months at the beginning of the study.”
A total of 12 patients in the MMF group discontinued the intervention for various reasons, and 6 were lost to follow-up. In the control group, 20 discontinued the intervention and two were lost to follow-up. However, all 130 patients in the trial were included in the primary and secondary outcome analyses.
Should clinicians consider prescribing MMF to patients with new-onset SLE? “We usually wait until later when there are indications of more severe disease, but here they started it from the time of diagnosis if the patient was anti-dsDNA positive. Given insurance restrictions in this country, we would be unlikely to be able to do that for many patients,” Dr. Costenbader said. “They likely also overtreated a lot of patients who didn’t need it. Due to our lack of more specific biomarkers and precision medicine for lupus, we do currently undertreat a lot of patients, as this study highlights, as well as overtreat others.”
How Much Might Cost Factor Into Treatment Decisions?
The study did not examine cost. Prednisone and hydroxychloroquine sulfate are inexpensive, but Dr. James said MMF can cost about $450 a month at the study dosage. However, “the average hospitalization without an ICU [intensive care unit] visit for an SLE patient is about $15,000-$20,000. If you can avoid one hospitalization, you can pay for nearly 4 years of MMF. More importantly, from a financial perspective, if you can convert a severe lupus patient to a mild/moderate lupus patient, then the annual costs of lupus decrease nearly by half, from about $52,000 per year to $25,000 per year.”
The study authors noted various limitations such as the small number of subjects, the need for a longer trial “to determine the advantages and disadvantages of early application of MMF,” and the fact that all subjects were Asian. The authors also called for confirmation via a double-blind, placebo-controlled study.
The study was funded by grants to the authors by the National Natural Science Foundation of China, Shanghai Rising-Star Program, Natural Science Foundation of Shanghai, Five-Year National Key R&D Program, and Ruijin–Zhongmei Huadong Lupus Funding. The authors had no disclosures. Dr. Costenbader disclosed consulting/research collaboration relationships with AstraZeneca, Amgen, Biogen, Bristol-Myers Squibb, GSK, Merck, Gilead, and Cabaletta. Dr. James and Dr. Wallace had no disclosures.
A version of this article first appeared on Medscape.com.
Early use of mycophenolate mofetil (MMF), a drug used to dampen the immune system in organ transplant recipients, may reduce the risk for severe flares in patients with newly diagnosed systemic lupus erythematosus (SLE), according to results from a randomized, open-label, observer-blinded clinical trial.
In interviews, two SLE specialists who were not involved with the study said the research is preliminary but promising. However, another specialist criticized the paper’s reliance on unusual doses of prednisone and MMF, saying it “puts people on a treatment regimen that nobody ever uses.”
The Lupus Foundation of America estimates that about 16,000 people in the United States are diagnosed with lupus each year. “Our current treatment paradigm is to go pretty slowly and start treatment for new-onset, mild SLE with glucocorticoids, if necessary, and hydroxychloroquine,” said Karen H. Costenbader, MD, MPH, of Harvard Medical School and Harvard School of Public Health, Boston, Massachusetts.
Stronger immunosuppressive agents may be added as patients progress, she said.
Off-label use of MMF, which is approved by the Food and Drug Administration only for patients with certain organ transplants, may be appropriate in some cases, she said. “There is a big push to start immunosuppressives earlier, but we currently would reserve mycophenolate for those with severe manifestations — lupus nephritis; vasculitis; or lung, brain, or heart inflammation.”
In the trial, adult patients who received oral prednisone (starting at 0.5 mg/kg per day) and hydroxychloroquine sulfate (5 mg/kg per day) plus MMF (500 mg twice daily) for 96 weeks were less likely to develop severe flares than those who took the regimen without MMF (relative risk [RR], 0.39; 95% CI, 0.17-0.87; P = .01). Severe flares occurred in 10.8% of the MMF group (7 of 65 patients) and in 27.7% of the control group (18 of 65), Yijun You, MD, of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues reported in JAMA Network Open.
Patients in the MMF group also had 89% lower risk for lupus nephritis than those in the control group (RR, 0.11; 95% CI, 0.01-0.85; P = .008), with kidney involvement occurring in 1.5% (1 of 65) vs 13.8% (9 of 65).
During 2018-2021, researchers recruited 130 patients in China aged 18-65 years with newly diagnosed SLE, a high titer of anti–double-stranded DNA (dsDNA) antibodies, and no major organ involvement (mean age, 34.5 years; 86.2% women). Patients’ initial 0.5–mg/kg per day prednisone dose was maintained for 4 weeks, then tapered by 5.0 mg every 2 weeks, and when the dose had been reduced to 20.0 mg/day, it was tapered by 5 mg every month and then gradually to 0.1-0.2 mg/kg per day. If patients had severe flares, they stopped taking MMF. (The study authors did not respond to requests for comment on the study.)
‘A Treatment Regimen That Nobody Ever Uses’
While Dr. Costenbader called the study “very interesting” and said “every person diagnosing or taking care of patients with lupus should be familiar” with it, she noted that the prednisone doses were high. “I am wondering why they used quite so much glucocorticoid for everyone. This may have masked some of the MMF effect and biased toward the null. They also used a low dose of MMF and did not ramp it up as we would normally to a full dose. That being said, it is remarkable that it was well-tolerated and resulted in better outcomes over the period of the trial.”
Daniel J. Wallace, MD, of Cedars-Sinai Medical Center, Los Angeles, California, and the University of California, Los Angeles, also highlighted the high doses of prednisone and low doses of MMF. “It’s a useless paper that puts people on a treatment regimen that nobody ever uses,” he said.
The rates of mild to moderate flares were similar between the control and intervention groups (38.5% vs 36.9%, respectively; RR, 0.96; P = .90). This finding is surprising, said Judith A. James, MD, PhD, executive vice president, chief medical officer, and head of the rheumatology clinic and Arthritis and Clinical Immunology Research Program at the Oklahoma Medical Research Foundation in Oklahoma City and also the Associate Vice Provost of Clinical & Translational Science, professor of medicine, and George Lynn Cross Research Professor at the University of Oklahoma Health Sciences Center in Oklahoma City. “It may be that mild flares have a different mechanism or are caused by noninflammatory endotypes that don’t respond to MMF.”
Dr. Costenbader noted that a risk-benefit analysis will need to be done to take the risks of MMF into account. “However, every time that a person flares or is not in lupus low-disease activity state, potentially permanent organ damage is done and the patient suffers,” she said. “Preventing lupus nephritis de novo was also seen — nine cases potentially prevented — and that is also really interesting. It would be amazing if we could completely avoid that life-threatening complication.”
MMF can cause miscarriage and boost the risk for birth defects, and the manufacturer says it can lower the effectiveness of birth control pills. It can also boost the risk for some cancers such as lymphoma and increase the risk for infections.
Surprisingly, the number of adverse events in the control and intervention groups were similar (35.4% vs 46.2%, respectively; RR, 1.30; 95% CI, 0.86-1.99; P = .20). They included infection (30.8% vs 33.8%, respectively; P = .70) and gastrointestinal tract events (16.9% for both; P > .99).
“There were overall pretty similar rates of side effects, but maybe this was because MMF dose was pretty low in the treated group, or the glucocorticoid dose was not so low in both groups,” Dr. Costenbader said. She also noted that “the risk of malignancy with MMF is longer term than this study. It may not show up for 5-10 or even more years, but we know it exists. Infections are also increased with MMF — some of which can be avoided with vaccines for COVID, pneumonia, influenza, shingles, etc. MMF also causes gastrointestinal intolerance, and people often are not able to take it because of nausea, vomiting, diarrhea, and elevated liver function tests.”
Dr. James said the infection rates “may be due to the higher doses of steroids patients in both groups are on for several months at the beginning of the study.”
A total of 12 patients in the MMF group discontinued the intervention for various reasons, and 6 were lost to follow-up. In the control group, 20 discontinued the intervention and two were lost to follow-up. However, all 130 patients in the trial were included in the primary and secondary outcome analyses.
Should clinicians consider prescribing MMF to patients with new-onset SLE? “We usually wait until later when there are indications of more severe disease, but here they started it from the time of diagnosis if the patient was anti-dsDNA positive. Given insurance restrictions in this country, we would be unlikely to be able to do that for many patients,” Dr. Costenbader said. “They likely also overtreated a lot of patients who didn’t need it. Due to our lack of more specific biomarkers and precision medicine for lupus, we do currently undertreat a lot of patients, as this study highlights, as well as overtreat others.”
How Much Might Cost Factor Into Treatment Decisions?
The study did not examine cost. Prednisone and hydroxychloroquine sulfate are inexpensive, but Dr. James said MMF can cost about $450 a month at the study dosage. However, “the average hospitalization without an ICU [intensive care unit] visit for an SLE patient is about $15,000-$20,000. If you can avoid one hospitalization, you can pay for nearly 4 years of MMF. More importantly, from a financial perspective, if you can convert a severe lupus patient to a mild/moderate lupus patient, then the annual costs of lupus decrease nearly by half, from about $52,000 per year to $25,000 per year.”
The study authors noted various limitations such as the small number of subjects, the need for a longer trial “to determine the advantages and disadvantages of early application of MMF,” and the fact that all subjects were Asian. The authors also called for confirmation via a double-blind, placebo-controlled study.
The study was funded by grants to the authors by the National Natural Science Foundation of China, Shanghai Rising-Star Program, Natural Science Foundation of Shanghai, Five-Year National Key R&D Program, and Ruijin–Zhongmei Huadong Lupus Funding. The authors had no disclosures. Dr. Costenbader disclosed consulting/research collaboration relationships with AstraZeneca, Amgen, Biogen, Bristol-Myers Squibb, GSK, Merck, Gilead, and Cabaletta. Dr. James and Dr. Wallace had no disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Hypnosis May Offer Relief During Sharp Debridement of Skin Ulcers
TOPLINE:
Hypnosis reduces pain during sharp debridement of skin ulcers in patients with immune-mediated inflammatory diseases, with most patients reporting decreased pain awareness and lasting pain relief for 2-3 days after the procedure.
METHODOLOGY:
- Researchers reported their experience with the anecdotal use of hypnosis for pain management in debridement of skin ulcers in immune-mediated inflammatory diseases.
- They studied 16 participants (14 women; mean age, 56 years; 14 with systemic sclerosis or morphea) with recurrent skin ulcerations requiring sharp debridement, who presented to a wound care clinic at the Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom. The participants had negative experiences with pharmacologic pain management.
- Participants consented to hypnosis during debridement as the only mode of analgesia, conducted by the same hypnosis-trained, experienced healthcare professional in charge of their ulcer care.
- Ulcer pain scores were recorded using a numerical rating pain scale before and immediately after debridement, with a score of 0 indicating no pain and 10 indicating worst pain.
TAKEAWAY:
- Hypnosis reduced the median pre-debridement ulcer pain score from 8 (interquartile range [IQR], 7-10) to 0.5 (IQR, 0-2) immediately after the procedure.
- Of 16 participants, 14 reported being aware of the procedure but not feeling the pain, with only two participants experiencing a brief spike in pain.
- The other two participants reported experiencing reduced awareness and being pain-free during the procedure.
- Five participants reported a lasting decrease in pain perception for 2-3 days after the procedure.
IN PRACTICE:
“These preliminary data underscore the potential for the integration of hypnosis into the management of intervention-related pain in clinical care,” the authors wrote.
SOURCE:
The study was led by Begonya Alcacer-Pitarch, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, the University of Leeds, and Chapel Allerton Hospital in Leeds, United Kingdom. It was published as a correspondence on September 10, 2024, in The Lancet Rheumatology.
LIMITATIONS:
The small sample size may limit the generalizability of the findings. The methods used for data collection were not standardized, and the individuals included in the study may have introduced selection bias.
DISCLOSURES:
The study did not have a funding source. The authors declared no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Hypnosis reduces pain during sharp debridement of skin ulcers in patients with immune-mediated inflammatory diseases, with most patients reporting decreased pain awareness and lasting pain relief for 2-3 days after the procedure.
METHODOLOGY:
- Researchers reported their experience with the anecdotal use of hypnosis for pain management in debridement of skin ulcers in immune-mediated inflammatory diseases.
- They studied 16 participants (14 women; mean age, 56 years; 14 with systemic sclerosis or morphea) with recurrent skin ulcerations requiring sharp debridement, who presented to a wound care clinic at the Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom. The participants had negative experiences with pharmacologic pain management.
- Participants consented to hypnosis during debridement as the only mode of analgesia, conducted by the same hypnosis-trained, experienced healthcare professional in charge of their ulcer care.
- Ulcer pain scores were recorded using a numerical rating pain scale before and immediately after debridement, with a score of 0 indicating no pain and 10 indicating worst pain.
TAKEAWAY:
- Hypnosis reduced the median pre-debridement ulcer pain score from 8 (interquartile range [IQR], 7-10) to 0.5 (IQR, 0-2) immediately after the procedure.
- Of 16 participants, 14 reported being aware of the procedure but not feeling the pain, with only two participants experiencing a brief spike in pain.
- The other two participants reported experiencing reduced awareness and being pain-free during the procedure.
- Five participants reported a lasting decrease in pain perception for 2-3 days after the procedure.
IN PRACTICE:
“These preliminary data underscore the potential for the integration of hypnosis into the management of intervention-related pain in clinical care,” the authors wrote.
SOURCE:
The study was led by Begonya Alcacer-Pitarch, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, the University of Leeds, and Chapel Allerton Hospital in Leeds, United Kingdom. It was published as a correspondence on September 10, 2024, in The Lancet Rheumatology.
LIMITATIONS:
The small sample size may limit the generalizability of the findings. The methods used for data collection were not standardized, and the individuals included in the study may have introduced selection bias.
DISCLOSURES:
The study did not have a funding source. The authors declared no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Hypnosis reduces pain during sharp debridement of skin ulcers in patients with immune-mediated inflammatory diseases, with most patients reporting decreased pain awareness and lasting pain relief for 2-3 days after the procedure.
METHODOLOGY:
- Researchers reported their experience with the anecdotal use of hypnosis for pain management in debridement of skin ulcers in immune-mediated inflammatory diseases.
- They studied 16 participants (14 women; mean age, 56 years; 14 with systemic sclerosis or morphea) with recurrent skin ulcerations requiring sharp debridement, who presented to a wound care clinic at the Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom. The participants had negative experiences with pharmacologic pain management.
- Participants consented to hypnosis during debridement as the only mode of analgesia, conducted by the same hypnosis-trained, experienced healthcare professional in charge of their ulcer care.
- Ulcer pain scores were recorded using a numerical rating pain scale before and immediately after debridement, with a score of 0 indicating no pain and 10 indicating worst pain.
TAKEAWAY:
- Hypnosis reduced the median pre-debridement ulcer pain score from 8 (interquartile range [IQR], 7-10) to 0.5 (IQR, 0-2) immediately after the procedure.
- Of 16 participants, 14 reported being aware of the procedure but not feeling the pain, with only two participants experiencing a brief spike in pain.
- The other two participants reported experiencing reduced awareness and being pain-free during the procedure.
- Five participants reported a lasting decrease in pain perception for 2-3 days after the procedure.
IN PRACTICE:
“These preliminary data underscore the potential for the integration of hypnosis into the management of intervention-related pain in clinical care,” the authors wrote.
SOURCE:
The study was led by Begonya Alcacer-Pitarch, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, the University of Leeds, and Chapel Allerton Hospital in Leeds, United Kingdom. It was published as a correspondence on September 10, 2024, in The Lancet Rheumatology.
LIMITATIONS:
The small sample size may limit the generalizability of the findings. The methods used for data collection were not standardized, and the individuals included in the study may have introduced selection bias.
DISCLOSURES:
The study did not have a funding source. The authors declared no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Benralizumab Now FDA Approved to Treat EGPA Vasculitis
The Food and Drug Administration (FDA) has approved benralizumab (Fasenra) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome.
The drug is the second approved biologic for the treatment of EGPA. The first, mepolizumab (Nucala), was approved in 2017.
“This disease has a devastating impact on patients and the quality of their life, and they need more treatment options. The approval of another treatment in EGPA is welcome news to the approximately 15,000 patients living in the US with this difficult-to-treat rare disease,” said Joyce Kullman, executive director of the Vasculitis Foundation, in a press release on September 18. 
Benralizumab, developed by AstraZeneca, is a monoclonal antibody against the interleukin-5 alpha receptor expressed on eosinophils. The drug was first approved in 2017 as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and is now approved for use in children aged 6 years and older.
The new indication was based on positive results from a noninferiority trial comparing benralizumab and mepolizumab. For the trial, published in the New England Journal of Medicine earlier in 2024, 140 adults with relapsing or refractory EGPA were randomized to a 30-mg subcutaneous injection of benralizumab or three separate 100-mg mepolizumab injections every 4 weeks for 1 year. At weeks 36 and 48, 59% of patients in the benralizumab group and 56% of patients in the mepolizumab group achieved remission (95% CI, –13 to 18; P = .73 for superiority). From week 42 to 52, 41% of patients who received benralizumab completely stopped taking oral glucocorticoids, compared with 26% of those who received mepolizumab.
“Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy,” Michael Wechsler, MD, director of The Asthma Institute at National Jewish Health in Denver, Colorado, and the international coordinating investigator for the clinical trial, said in the press release.
Benralizumab is administered via subcutaneous injection. In adults with EGPA, the recommended dosage is 30 mg every 4 weeks for the first three doses, then once every 8 weeks.
The most common adverse reactions include headache and pharyngitis, according to the prescribing information.
Benralizumab is also in development for the treatment of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved benralizumab (Fasenra) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome.
The drug is the second approved biologic for the treatment of EGPA. The first, mepolizumab (Nucala), was approved in 2017.
“This disease has a devastating impact on patients and the quality of their life, and they need more treatment options. The approval of another treatment in EGPA is welcome news to the approximately 15,000 patients living in the US with this difficult-to-treat rare disease,” said Joyce Kullman, executive director of the Vasculitis Foundation, in a press release on September 18.
Benralizumab, developed by AstraZeneca, is a monoclonal antibody against the interleukin-5 alpha receptor expressed on eosinophils. The drug was first approved in 2017 as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and is now approved for use in children aged 6 years and older.
The new indication was based on positive results from a noninferiority trial comparing benralizumab and mepolizumab. For the trial, published in the New England Journal of Medicine earlier in 2024, 140 adults with relapsing or refractory EGPA were randomized to a 30-mg subcutaneous injection of benralizumab or three separate 100-mg mepolizumab injections every 4 weeks for 1 year. At weeks 36 and 48, 59% of patients in the benralizumab group and 56% of patients in the mepolizumab group achieved remission (95% CI, –13 to 18; P = .73 for superiority). From week 42 to 52, 41% of patients who received benralizumab completely stopped taking oral glucocorticoids, compared with 26% of those who received mepolizumab.
“Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy,” Michael Wechsler, MD, director of The Asthma Institute at National Jewish Health in Denver, Colorado, and the international coordinating investigator for the clinical trial, said in the press release.
Benralizumab is administered via subcutaneous injection. In adults with EGPA, the recommended dosage is 30 mg every 4 weeks for the first three doses, then once every 8 weeks.
The most common adverse reactions include headache and pharyngitis, according to the prescribing information.
Benralizumab is also in development for the treatment of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved benralizumab (Fasenra) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome.
The drug is the second approved biologic for the treatment of EGPA. The first, mepolizumab (Nucala), was approved in 2017.
“This disease has a devastating impact on patients and the quality of their life, and they need more treatment options. The approval of another treatment in EGPA is welcome news to the approximately 15,000 patients living in the US with this difficult-to-treat rare disease,” said Joyce Kullman, executive director of the Vasculitis Foundation, in a press release on September 18.
Benralizumab, developed by AstraZeneca, is a monoclonal antibody against the interleukin-5 alpha receptor expressed on eosinophils. The drug was first approved in 2017 as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and is now approved for use in children aged 6 years and older.
The new indication was based on positive results from a noninferiority trial comparing benralizumab and mepolizumab. For the trial, published in the New England Journal of Medicine earlier in 2024, 140 adults with relapsing or refractory EGPA were randomized to a 30-mg subcutaneous injection of benralizumab or three separate 100-mg mepolizumab injections every 4 weeks for 1 year. At weeks 36 and 48, 59% of patients in the benralizumab group and 56% of patients in the mepolizumab group achieved remission (95% CI, –13 to 18; P = .73 for superiority). From week 42 to 52, 41% of patients who received benralizumab completely stopped taking oral glucocorticoids, compared with 26% of those who received mepolizumab.
“Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy,” Michael Wechsler, MD, director of The Asthma Institute at National Jewish Health in Denver, Colorado, and the international coordinating investigator for the clinical trial, said in the press release.
Benralizumab is administered via subcutaneous injection. In adults with EGPA, the recommended dosage is 30 mg every 4 weeks for the first three doses, then once every 8 weeks.
The most common adverse reactions include headache and pharyngitis, according to the prescribing information.
Benralizumab is also in development for the treatment of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.
A version of this article first appeared on Medscape.com.
Rheumatology Clinic Interventions for Smoking, Blood Pressure ‘Make a Big Difference’
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
ANCA-Associated Vasculitis Has Five Unique Patient Clusters
TOPLINE:
A data-driven subclassification of antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis has identified five distinct clusters with varying degrees of kidney involvement and systemic inflammation, offering insights into improved patient stratification and treatment approaches.
METHODOLOGY:
- ANCA-associated vasculitis is a rare and complex autoimmune disease that is traditionally classified into granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
- Researchers employed advanced artificial intelligence and big data techniques to identify phenotypically distinct subgroups of ANCA-associated vasculitis and developed a classification system using real-world patient data from the Federated Vasculitis Registry consortium.
- They included 3868 patients diagnosed with ANCA-associated vasculitis between November 1, 1966, and March 1, 2023 (mean age at diagnosis, 57.2 years; 51.9% men), across six European vasculitis registries; while a majority of patients (62.9%) were diagnosed with GPA, the remaining 37.1% were diagnosed with MPA.
- Overall, 17 clinical and demographic variables such as the age at diagnosis, gender, serum creatinine and C-reactive protein levels, the type of ANCA, and the involvement of various organ systems were used to create a model for categorizing patients into different clusters.
- The median follow-up duration was 4.2 years.
TAKEAWAY:
- Five distinct clusters were identified in ANCA-associated vasculitis; three had significant kidney involvement (the severe kidney cluster, myeloperoxidase-ANCA-positive kidney cluster, and proteinase 3-ANCA-positive kidney cluster) and two had minimal kidney involvement (young respiratory cluster and inflammatory multisystem cluster).
- The clusters with significant kidney involvement were associated with poorer outcomes, including a higher risk for kidney failure and death. The severe kidney cluster had the poorest prognosis, with mortality and the rate of end-stage kidney failure being 30.5% and 41.6%, respectively.
- The young respiratory cluster, characterized by predominant ear-nose-throat involvement and low systemic inflammation, showed the best prognostic outcomes.
- This cluster membership model showed a greater predictive accuracy for patient and kidney survival than traditional methods based on clinical diagnosis or ANCA specificity.
IN PRACTICE:
“These findings highlight the necessity of recognizing severe kidney disease at the time of diagnosis as an indicator of poor outcome, thereby necessitating intensified treatment approaches,” experts from the Department of Internal Medicine IV (Nephrology and Hypertension), Medical University of Innsbruck, Austria, wrote in an accompanying editorial published online on August 22, 2024, in The Lancet Rheumatology.
SOURCE:
This study was led by Karl Gisslander, Department of Clinical Sciences, Lund University, Lund, Sweden, and was published online on August 22, 2024, in The Lancet Rheumatology.
LIMITATIONS:
Data on estimated glomerular filtration rate recovery in clusters with kidney disease were lacking. Populations from East Asia, where myeloperoxidase-ANCA positivity is more prevalent, were not included.
DISCLOSURES:
This study received funding from the European Union’s Horizon 2020 research and innovation program under the European Joint Programme on Rare Diseases. Some authors declared serving on advisory boards or receiving grants, contracts, travel support, consulting fees, payments, or honoraria from various pharmaceutical companies and other institutions.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A data-driven subclassification of antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis has identified five distinct clusters with varying degrees of kidney involvement and systemic inflammation, offering insights into improved patient stratification and treatment approaches.
METHODOLOGY:
- ANCA-associated vasculitis is a rare and complex autoimmune disease that is traditionally classified into granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
- Researchers employed advanced artificial intelligence and big data techniques to identify phenotypically distinct subgroups of ANCA-associated vasculitis and developed a classification system using real-world patient data from the Federated Vasculitis Registry consortium.
- They included 3868 patients diagnosed with ANCA-associated vasculitis between November 1, 1966, and March 1, 2023 (mean age at diagnosis, 57.2 years; 51.9% men), across six European vasculitis registries; while a majority of patients (62.9%) were diagnosed with GPA, the remaining 37.1% were diagnosed with MPA.
- Overall, 17 clinical and demographic variables such as the age at diagnosis, gender, serum creatinine and C-reactive protein levels, the type of ANCA, and the involvement of various organ systems were used to create a model for categorizing patients into different clusters.
- The median follow-up duration was 4.2 years.
TAKEAWAY:
- Five distinct clusters were identified in ANCA-associated vasculitis; three had significant kidney involvement (the severe kidney cluster, myeloperoxidase-ANCA-positive kidney cluster, and proteinase 3-ANCA-positive kidney cluster) and two had minimal kidney involvement (young respiratory cluster and inflammatory multisystem cluster).
- The clusters with significant kidney involvement were associated with poorer outcomes, including a higher risk for kidney failure and death. The severe kidney cluster had the poorest prognosis, with mortality and the rate of end-stage kidney failure being 30.5% and 41.6%, respectively.
- The young respiratory cluster, characterized by predominant ear-nose-throat involvement and low systemic inflammation, showed the best prognostic outcomes.
- This cluster membership model showed a greater predictive accuracy for patient and kidney survival than traditional methods based on clinical diagnosis or ANCA specificity.
IN PRACTICE:
“These findings highlight the necessity of recognizing severe kidney disease at the time of diagnosis as an indicator of poor outcome, thereby necessitating intensified treatment approaches,” experts from the Department of Internal Medicine IV (Nephrology and Hypertension), Medical University of Innsbruck, Austria, wrote in an accompanying editorial published online on August 22, 2024, in The Lancet Rheumatology.
SOURCE:
This study was led by Karl Gisslander, Department of Clinical Sciences, Lund University, Lund, Sweden, and was published online on August 22, 2024, in The Lancet Rheumatology.
LIMITATIONS:
Data on estimated glomerular filtration rate recovery in clusters with kidney disease were lacking. Populations from East Asia, where myeloperoxidase-ANCA positivity is more prevalent, were not included.
DISCLOSURES:
This study received funding from the European Union’s Horizon 2020 research and innovation program under the European Joint Programme on Rare Diseases. Some authors declared serving on advisory boards or receiving grants, contracts, travel support, consulting fees, payments, or honoraria from various pharmaceutical companies and other institutions.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A data-driven subclassification of antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis has identified five distinct clusters with varying degrees of kidney involvement and systemic inflammation, offering insights into improved patient stratification and treatment approaches.
METHODOLOGY:
- ANCA-associated vasculitis is a rare and complex autoimmune disease that is traditionally classified into granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
- Researchers employed advanced artificial intelligence and big data techniques to identify phenotypically distinct subgroups of ANCA-associated vasculitis and developed a classification system using real-world patient data from the Federated Vasculitis Registry consortium.
- They included 3868 patients diagnosed with ANCA-associated vasculitis between November 1, 1966, and March 1, 2023 (mean age at diagnosis, 57.2 years; 51.9% men), across six European vasculitis registries; while a majority of patients (62.9%) were diagnosed with GPA, the remaining 37.1% were diagnosed with MPA.
- Overall, 17 clinical and demographic variables such as the age at diagnosis, gender, serum creatinine and C-reactive protein levels, the type of ANCA, and the involvement of various organ systems were used to create a model for categorizing patients into different clusters.
- The median follow-up duration was 4.2 years.
TAKEAWAY:
- Five distinct clusters were identified in ANCA-associated vasculitis; three had significant kidney involvement (the severe kidney cluster, myeloperoxidase-ANCA-positive kidney cluster, and proteinase 3-ANCA-positive kidney cluster) and two had minimal kidney involvement (young respiratory cluster and inflammatory multisystem cluster).
- The clusters with significant kidney involvement were associated with poorer outcomes, including a higher risk for kidney failure and death. The severe kidney cluster had the poorest prognosis, with mortality and the rate of end-stage kidney failure being 30.5% and 41.6%, respectively.
- The young respiratory cluster, characterized by predominant ear-nose-throat involvement and low systemic inflammation, showed the best prognostic outcomes.
- This cluster membership model showed a greater predictive accuracy for patient and kidney survival than traditional methods based on clinical diagnosis or ANCA specificity.
IN PRACTICE:
“These findings highlight the necessity of recognizing severe kidney disease at the time of diagnosis as an indicator of poor outcome, thereby necessitating intensified treatment approaches,” experts from the Department of Internal Medicine IV (Nephrology and Hypertension), Medical University of Innsbruck, Austria, wrote in an accompanying editorial published online on August 22, 2024, in The Lancet Rheumatology.
SOURCE:
This study was led by Karl Gisslander, Department of Clinical Sciences, Lund University, Lund, Sweden, and was published online on August 22, 2024, in The Lancet Rheumatology.
LIMITATIONS:
Data on estimated glomerular filtration rate recovery in clusters with kidney disease were lacking. Populations from East Asia, where myeloperoxidase-ANCA positivity is more prevalent, were not included.
DISCLOSURES:
This study received funding from the European Union’s Horizon 2020 research and innovation program under the European Joint Programme on Rare Diseases. Some authors declared serving on advisory boards or receiving grants, contracts, travel support, consulting fees, payments, or honoraria from various pharmaceutical companies and other institutions.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Belimumab Hits Newer Remission, Low Disease Activity Metrics
TOPLINE:
A greater proportion of patients with active systemic lupus erythematosus (SLE) treated with belimumab plus standard therapy achieved the newest definitions for remission and low disease activity compared with those treated with placebo plus standard therapy, with benefits observed as early as week 28 for remission and week 8 for disease activity, according to pooled results from five clinical trials.
METHODOLOGY:
- Researchers conducted an integrated post hoc analysis of five randomized phase 3 clinical trials to evaluate the attainment of remission and low disease activity in adult patients with active, autoantibody-positive SLE.
- A total of 3086 patients (median age, 36 years; 94% women) were randomly assigned to receive standard therapy with intravenous belimumab 10 mg/kg monthly or subcutaneous belimumab 200 mg weekly (n = 1869) or placebo (n = 1217).
- The proportion of patients who achieved definitions of remission in SLE (DORIS) remission and lupus low disease activity state (LLDAS) by visit up to week 52 was assessed.
- The analysis also evaluated the time taken to achieve sustained (at least two consecutive visits) and maintained (up to week 52) DORIS remission and LLDAS.
TAKEAWAY:
- At week 52, a higher proportion of patients receiving belimumab vs placebo achieved DORIS remission (8% vs 6%; risk ratio [RR], 1.51; P = .0055) and LLDAS (17% vs 10%; RR, 1.74; P < .0001).
- The earliest observed significant benefit of belimumab over placebo in patients with a higher baseline disease activity was at week 20 for DORIS remission (RR, 2.09; P = .043) and at week 16 for LLDAS (RR, 1.46; P = .034), with both maintained through week 52.
- The proportion of patients who attained DORIS remission and LLDAS as early as week 28 and week 8, respectively, was higher in the belimumab group than in the placebo group, with both maintained through week 52.
- Patients on belimumab were more likely to have a sustained and maintained DORIS remission (hazard ratio [HR], 1.53; P = .013) and LLDAS (HR, 1.79; P < .0001) at any timepoint.
IN PRACTICE:
“The data clearly support that belimumab is a valuable addition toward accomplishing and maintaining remission or LLDAS,” George Bertsias, MD, PhD, University of Crete Medical School, Heraklion, Greece, and Jinoos Yazdany, MD, University of California San Francisco, wrote in a related comment.
SOURCE:
This study, led by Ioannis Parodis, MD, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden, was published online on August 26, 2024, in The Lancet Rheumatology.
LIMITATIONS:
Due to the post hoc nature of the analysis, the trials were not specifically designed to have adequate statistical power to demonstrate the difference between patients who did or did not achieve DORIS remission or LLDAS. The analysis was limited to patients who met the eligibility criteria, and the outcomes are not generalizable to populations outside a clinical trial setting. The study population had high disease activity, which made it challenging to attain the treatment targets.
DISCLOSURES:
The five trials included in this analysis were funded by GSK. The study was supported by the Swedish Rheumatism Association, King Gustaf V’s 80-year Foundation, the Swedish Society of Medicine, Nyckelfonden, Professor Nanna Svartz Foundation, Ulla and Roland Gustafsson Foundation, Region Stockholm, and Karolinska Institutet. Some authors reported receiving grants, speaker honoraria, or consulting fees from various pharmaceutical companies. Some authors reported being employees and owning stocks and shares of GSK.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A greater proportion of patients with active systemic lupus erythematosus (SLE) treated with belimumab plus standard therapy achieved the newest definitions for remission and low disease activity compared with those treated with placebo plus standard therapy, with benefits observed as early as week 28 for remission and week 8 for disease activity, according to pooled results from five clinical trials.
METHODOLOGY:
- Researchers conducted an integrated post hoc analysis of five randomized phase 3 clinical trials to evaluate the attainment of remission and low disease activity in adult patients with active, autoantibody-positive SLE.
- A total of 3086 patients (median age, 36 years; 94% women) were randomly assigned to receive standard therapy with intravenous belimumab 10 mg/kg monthly or subcutaneous belimumab 200 mg weekly (n = 1869) or placebo (n = 1217).
- The proportion of patients who achieved definitions of remission in SLE (DORIS) remission and lupus low disease activity state (LLDAS) by visit up to week 52 was assessed.
- The analysis also evaluated the time taken to achieve sustained (at least two consecutive visits) and maintained (up to week 52) DORIS remission and LLDAS.
TAKEAWAY:
- At week 52, a higher proportion of patients receiving belimumab vs placebo achieved DORIS remission (8% vs 6%; risk ratio [RR], 1.51; P = .0055) and LLDAS (17% vs 10%; RR, 1.74; P < .0001).
- The earliest observed significant benefit of belimumab over placebo in patients with a higher baseline disease activity was at week 20 for DORIS remission (RR, 2.09; P = .043) and at week 16 for LLDAS (RR, 1.46; P = .034), with both maintained through week 52.
- The proportion of patients who attained DORIS remission and LLDAS as early as week 28 and week 8, respectively, was higher in the belimumab group than in the placebo group, with both maintained through week 52.
- Patients on belimumab were more likely to have a sustained and maintained DORIS remission (hazard ratio [HR], 1.53; P = .013) and LLDAS (HR, 1.79; P < .0001) at any timepoint.
IN PRACTICE:
“The data clearly support that belimumab is a valuable addition toward accomplishing and maintaining remission or LLDAS,” George Bertsias, MD, PhD, University of Crete Medical School, Heraklion, Greece, and Jinoos Yazdany, MD, University of California San Francisco, wrote in a related comment.
SOURCE:
This study, led by Ioannis Parodis, MD, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden, was published online on August 26, 2024, in The Lancet Rheumatology.
LIMITATIONS:
Due to the post hoc nature of the analysis, the trials were not specifically designed to have adequate statistical power to demonstrate the difference between patients who did or did not achieve DORIS remission or LLDAS. The analysis was limited to patients who met the eligibility criteria, and the outcomes are not generalizable to populations outside a clinical trial setting. The study population had high disease activity, which made it challenging to attain the treatment targets.
DISCLOSURES:
The five trials included in this analysis were funded by GSK. The study was supported by the Swedish Rheumatism Association, King Gustaf V’s 80-year Foundation, the Swedish Society of Medicine, Nyckelfonden, Professor Nanna Svartz Foundation, Ulla and Roland Gustafsson Foundation, Region Stockholm, and Karolinska Institutet. Some authors reported receiving grants, speaker honoraria, or consulting fees from various pharmaceutical companies. Some authors reported being employees and owning stocks and shares of GSK.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
A greater proportion of patients with active systemic lupus erythematosus (SLE) treated with belimumab plus standard therapy achieved the newest definitions for remission and low disease activity compared with those treated with placebo plus standard therapy, with benefits observed as early as week 28 for remission and week 8 for disease activity, according to pooled results from five clinical trials.
METHODOLOGY:
- Researchers conducted an integrated post hoc analysis of five randomized phase 3 clinical trials to evaluate the attainment of remission and low disease activity in adult patients with active, autoantibody-positive SLE.
- A total of 3086 patients (median age, 36 years; 94% women) were randomly assigned to receive standard therapy with intravenous belimumab 10 mg/kg monthly or subcutaneous belimumab 200 mg weekly (n = 1869) or placebo (n = 1217).
- The proportion of patients who achieved definitions of remission in SLE (DORIS) remission and lupus low disease activity state (LLDAS) by visit up to week 52 was assessed.
- The analysis also evaluated the time taken to achieve sustained (at least two consecutive visits) and maintained (up to week 52) DORIS remission and LLDAS.
TAKEAWAY:
- At week 52, a higher proportion of patients receiving belimumab vs placebo achieved DORIS remission (8% vs 6%; risk ratio [RR], 1.51; P = .0055) and LLDAS (17% vs 10%; RR, 1.74; P < .0001).
- The earliest observed significant benefit of belimumab over placebo in patients with a higher baseline disease activity was at week 20 for DORIS remission (RR, 2.09; P = .043) and at week 16 for LLDAS (RR, 1.46; P = .034), with both maintained through week 52.
- The proportion of patients who attained DORIS remission and LLDAS as early as week 28 and week 8, respectively, was higher in the belimumab group than in the placebo group, with both maintained through week 52.
- Patients on belimumab were more likely to have a sustained and maintained DORIS remission (hazard ratio [HR], 1.53; P = .013) and LLDAS (HR, 1.79; P < .0001) at any timepoint.
IN PRACTICE:
“The data clearly support that belimumab is a valuable addition toward accomplishing and maintaining remission or LLDAS,” George Bertsias, MD, PhD, University of Crete Medical School, Heraklion, Greece, and Jinoos Yazdany, MD, University of California San Francisco, wrote in a related comment.
SOURCE:
This study, led by Ioannis Parodis, MD, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden, was published online on August 26, 2024, in The Lancet Rheumatology.
LIMITATIONS:
Due to the post hoc nature of the analysis, the trials were not specifically designed to have adequate statistical power to demonstrate the difference between patients who did or did not achieve DORIS remission or LLDAS. The analysis was limited to patients who met the eligibility criteria, and the outcomes are not generalizable to populations outside a clinical trial setting. The study population had high disease activity, which made it challenging to attain the treatment targets.
DISCLOSURES:
The five trials included in this analysis were funded by GSK. The study was supported by the Swedish Rheumatism Association, King Gustaf V’s 80-year Foundation, the Swedish Society of Medicine, Nyckelfonden, Professor Nanna Svartz Foundation, Ulla and Roland Gustafsson Foundation, Region Stockholm, and Karolinska Institutet. Some authors reported receiving grants, speaker honoraria, or consulting fees from various pharmaceutical companies. Some authors reported being employees and owning stocks and shares of GSK.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
ANA Testing: When to Tap the Brakes
This transcript has been edited for clarity.
There are five reasons you do not want to order that notorious antinuclear antibody (ANA) test — when a patient comes into your office and you say, “Let’s just run a wellness check” and you order the ANA test, or the patient comes in and says, “Hey doc, order everything, okay?” — without really thinking these things through.
1. I’m sure you know that the ANA test, if positive, does not exclude other conditions. For instance, older women could have a positive ANA test; it’s very common in this group.
2. There’s a high false-positive rate for an ANA test. For instance, cancers and viral infections can cause an ANA test to be positive, and certain medications can cause a false-positive ANA test.
3. Context matters. If you have a patient that has particular symptoms, joint swelling, a strong family history of autoimmune disease, a luminal rash that you can’t understand, hair loss, those kind of things, then yes, when you order that ANA test, it’s going to be valuable. If the patient does not have those symptoms, you are just running down this rabbit hole that causes worry for you and your patient.
4. The ANA test on its own is not helpful until you order the subtypes. Double-stranded DNA and anti-SSA or anti-SSB antibodies are just a few examples of the subtypes of the ANA test that really help you understand what you ordered.
5. The elephant in the room: What is the pretest probability of your diagnostic test — all the symptoms, the hair loss, the malar rash, the sores in the mouth, the joint swelling, the blood in the urine? Fluid around the heart, pericarditis, pleurisy, those kinds of symptoms, right? When you have those symptoms and you order an ANA test, then you have basically put directions into your GPS. So now you know that if the test is positive, these are the things you’re going to do with the test going forward.
I hope that these five things have told you: Hey, before you order that ANA test, let’s make sure that we’re not causing unnecessary stress for our patients and also minimizing unnecessary testing.
Dr. Dada, CEO, Overlake Arthritis and Osteoporosis Center, Bellevue, Washington, disclosed ties with Horizon Pharmaceuticals.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
There are five reasons you do not want to order that notorious antinuclear antibody (ANA) test — when a patient comes into your office and you say, “Let’s just run a wellness check” and you order the ANA test, or the patient comes in and says, “Hey doc, order everything, okay?” — without really thinking these things through.
1. I’m sure you know that the ANA test, if positive, does not exclude other conditions. For instance, older women could have a positive ANA test; it’s very common in this group.
2. There’s a high false-positive rate for an ANA test. For instance, cancers and viral infections can cause an ANA test to be positive, and certain medications can cause a false-positive ANA test.
3. Context matters. If you have a patient that has particular symptoms, joint swelling, a strong family history of autoimmune disease, a luminal rash that you can’t understand, hair loss, those kind of things, then yes, when you order that ANA test, it’s going to be valuable. If the patient does not have those symptoms, you are just running down this rabbit hole that causes worry for you and your patient.
4. The ANA test on its own is not helpful until you order the subtypes. Double-stranded DNA and anti-SSA or anti-SSB antibodies are just a few examples of the subtypes of the ANA test that really help you understand what you ordered.
5. The elephant in the room: What is the pretest probability of your diagnostic test — all the symptoms, the hair loss, the malar rash, the sores in the mouth, the joint swelling, the blood in the urine? Fluid around the heart, pericarditis, pleurisy, those kinds of symptoms, right? When you have those symptoms and you order an ANA test, then you have basically put directions into your GPS. So now you know that if the test is positive, these are the things you’re going to do with the test going forward.
I hope that these five things have told you: Hey, before you order that ANA test, let’s make sure that we’re not causing unnecessary stress for our patients and also minimizing unnecessary testing.
Dr. Dada, CEO, Overlake Arthritis and Osteoporosis Center, Bellevue, Washington, disclosed ties with Horizon Pharmaceuticals.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
There are five reasons you do not want to order that notorious antinuclear antibody (ANA) test — when a patient comes into your office and you say, “Let’s just run a wellness check” and you order the ANA test, or the patient comes in and says, “Hey doc, order everything, okay?” — without really thinking these things through.
1. I’m sure you know that the ANA test, if positive, does not exclude other conditions. For instance, older women could have a positive ANA test; it’s very common in this group.
2. There’s a high false-positive rate for an ANA test. For instance, cancers and viral infections can cause an ANA test to be positive, and certain medications can cause a false-positive ANA test.
3. Context matters. If you have a patient that has particular symptoms, joint swelling, a strong family history of autoimmune disease, a luminal rash that you can’t understand, hair loss, those kind of things, then yes, when you order that ANA test, it’s going to be valuable. If the patient does not have those symptoms, you are just running down this rabbit hole that causes worry for you and your patient.
4. The ANA test on its own is not helpful until you order the subtypes. Double-stranded DNA and anti-SSA or anti-SSB antibodies are just a few examples of the subtypes of the ANA test that really help you understand what you ordered.
5. The elephant in the room: What is the pretest probability of your diagnostic test — all the symptoms, the hair loss, the malar rash, the sores in the mouth, the joint swelling, the blood in the urine? Fluid around the heart, pericarditis, pleurisy, those kinds of symptoms, right? When you have those symptoms and you order an ANA test, then you have basically put directions into your GPS. So now you know that if the test is positive, these are the things you’re going to do with the test going forward.
I hope that these five things have told you: Hey, before you order that ANA test, let’s make sure that we’re not causing unnecessary stress for our patients and also minimizing unnecessary testing.
Dr. Dada, CEO, Overlake Arthritis and Osteoporosis Center, Bellevue, Washington, disclosed ties with Horizon Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Current Hydroxychloroquine Use in Lupus May Provide Protection Against Cardiovascular Events
TOPLINE:
Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.
METHODOLOGY:
- Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
- They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
- Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
- Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
- The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.
TAKEAWAY:
- Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
- The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
- No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.
IN PRACTICE:
“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.
SOURCE:
The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.
LIMITATIONS:
The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.
DISCLOSURES:
This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.
METHODOLOGY:
- Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
- They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
- Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
- Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
- The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.
TAKEAWAY:
- Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
- The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
- No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.
IN PRACTICE:
“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.
SOURCE:
The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.
LIMITATIONS:
The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.
DISCLOSURES:
This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Current use of hydroxychloroquine is associated with a lower risk for myocardial infarction (MI), stroke, and other thromboembolic events in patients with systemic lupus erythematosus (SLE). This protective effect diminishes after discontinuation of hydroxychloroquine treatment.
METHODOLOGY:
- Researchers used a nested case-control design to evaluate the association between exposure to hydroxychloroquine and the risk for cardiovascular events in patients with SLE.
- They included 52,883 adults with SLE (mean age, 44.23 years; 86.6% women) identified from the National System of Health Databases, which includes 99% of the French population.
- Among these, 1981 individuals with composite cardiovascular conditions were matched with 16,892 control individuals without cardiovascular conditions.
- Patients were categorized on the basis of hydroxychloroquine exposure into current users (last exposure within 90 days before a cardiovascular event), remote users (91-365 days before), and nonusers (no exposure within 365 days).
- The study outcomes included a composite of cardiovascular events, including MI, stroke (including transient ischemic attack), and other thromboembolic events such as phlebitis, thrombophlebitis, venous thrombosis, venous thromboembolism, and pulmonary embolism.
TAKEAWAY:
- Current hydroxychloroquine users had lower odds of experiencing a composite cardiovascular outcome than nonusers (adjusted odds ratio [aOR], 0.63; 95% CI, 0.57-0.70).
- The odds of MI (aOR, 0.72; 95% CI, 0.60-0.87), stroke (aOR, 0.71; 95% CI, 0.61-0.83), and other thromboembolic events (aOR, 0.58; 95% CI, 0.48-0.69) were also lower among current users than among nonusers.
- No significant association was found for remote hydroxychloroquine exposure and the risk for composite cardiovascular events, MI, stroke, and other thromboembolic events.
IN PRACTICE:
“These findings support the protective association of hydroxychloroquine against CV [cardiovascular] events and underscore the importance of continuous hydroxychloroquine therapy for patients diagnosed with SLE,” the authors wrote.
SOURCE:
The study was led by Lamiae Grimaldi-Bensouda, PharmD, PhD, Department of Pharmacology, Hospital Group Paris-Saclay, Assistance Publique-Hôpitaux de Paris, France. It was published online on August 30, 2024, in JAMA Network Open.
LIMITATIONS:
The observational nature of the study may have introduced confounding. Current hydroxychloroquine users were younger than nonusers, with an average age difference of almost 5 years. Current hydroxychloroquine users had a twofold longer duration of onset of SLE and had a higher prevalence of chronic kidney disease compared with nonusers.
DISCLOSURES:
This study was funded by the Banque pour l’Investissement, Deeptech. Some authors declared having financial ties with various institutions and companies outside of the current study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.