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Congress Directly Provides $10 Million for Arthritis Research for First Time
Congress provided $10 million to fund arthritis research in the recently passed federal fiscal year 2024 budget.
The new arthritis program is part of the Department of Defense’s (DOD’s) Congressionally Directed Medical Research Programs (CDMRP), which provides dedicated funding to study certain diseases and health conditions.
This is the first stand-alone research program for arthritis of the CDMRP, though the organization had previously funded arthritis-related research through their other programs, including chronic pain management, joint warfighter medical, peer-reviewed orthopedic, peer-reviewed medical, and tick-borne disease programs.
It is not yet known what specific aspects of arthritis this funding will go toward. The standard process for new programs involves speaking with researchers, clinicians, and individuals with these targeted health conditions to better understand research gaps and narrow focus, Akua Roach, PhD, the program manager for this new CDMRP arthritis research program, told this news organization.
“We’re not going to be able to solve every question,” she said, though the allocated $10 million is “a great number to do a lot of great work.”
While the CDMRP is under the DOD, research funding can go to studying patient populations outside of military personnel or veterans, she added.
“I think that is perhaps a common misconception that if you are getting funding from the DOD, that you have to have a DOD population, and that is not true,” she said.
Another misconception is that CDMRP funding only goes to military treatment facilities. In fact, on average, 92% of CDMRP funding goes to academia, industry, and other nonmilitary recipients, noted CDMRP Director Colonel Sarah Goldman.
“Anyone around the world can apply for funding,” she told this news organization. “We want to fund the best research.”
Because the funding is provided under the defense bill, there will be discussions around the military relevance of research, she added, which not only includes service members but also their families.
CDMRP anticipates that funding opportunities through this new arthritis research program will be available by July or August 2024.
A version of this article appeared on Medscape.com.
Congress provided $10 million to fund arthritis research in the recently passed federal fiscal year 2024 budget.
The new arthritis program is part of the Department of Defense’s (DOD’s) Congressionally Directed Medical Research Programs (CDMRP), which provides dedicated funding to study certain diseases and health conditions.
This is the first stand-alone research program for arthritis of the CDMRP, though the organization had previously funded arthritis-related research through their other programs, including chronic pain management, joint warfighter medical, peer-reviewed orthopedic, peer-reviewed medical, and tick-borne disease programs.
It is not yet known what specific aspects of arthritis this funding will go toward. The standard process for new programs involves speaking with researchers, clinicians, and individuals with these targeted health conditions to better understand research gaps and narrow focus, Akua Roach, PhD, the program manager for this new CDMRP arthritis research program, told this news organization.
“We’re not going to be able to solve every question,” she said, though the allocated $10 million is “a great number to do a lot of great work.”
While the CDMRP is under the DOD, research funding can go to studying patient populations outside of military personnel or veterans, she added.
“I think that is perhaps a common misconception that if you are getting funding from the DOD, that you have to have a DOD population, and that is not true,” she said.
Another misconception is that CDMRP funding only goes to military treatment facilities. In fact, on average, 92% of CDMRP funding goes to academia, industry, and other nonmilitary recipients, noted CDMRP Director Colonel Sarah Goldman.
“Anyone around the world can apply for funding,” she told this news organization. “We want to fund the best research.”
Because the funding is provided under the defense bill, there will be discussions around the military relevance of research, she added, which not only includes service members but also their families.
CDMRP anticipates that funding opportunities through this new arthritis research program will be available by July or August 2024.
A version of this article appeared on Medscape.com.
Congress provided $10 million to fund arthritis research in the recently passed federal fiscal year 2024 budget.
The new arthritis program is part of the Department of Defense’s (DOD’s) Congressionally Directed Medical Research Programs (CDMRP), which provides dedicated funding to study certain diseases and health conditions.
This is the first stand-alone research program for arthritis of the CDMRP, though the organization had previously funded arthritis-related research through their other programs, including chronic pain management, joint warfighter medical, peer-reviewed orthopedic, peer-reviewed medical, and tick-borne disease programs.
It is not yet known what specific aspects of arthritis this funding will go toward. The standard process for new programs involves speaking with researchers, clinicians, and individuals with these targeted health conditions to better understand research gaps and narrow focus, Akua Roach, PhD, the program manager for this new CDMRP arthritis research program, told this news organization.
“We’re not going to be able to solve every question,” she said, though the allocated $10 million is “a great number to do a lot of great work.”
While the CDMRP is under the DOD, research funding can go to studying patient populations outside of military personnel or veterans, she added.
“I think that is perhaps a common misconception that if you are getting funding from the DOD, that you have to have a DOD population, and that is not true,” she said.
Another misconception is that CDMRP funding only goes to military treatment facilities. In fact, on average, 92% of CDMRP funding goes to academia, industry, and other nonmilitary recipients, noted CDMRP Director Colonel Sarah Goldman.
“Anyone around the world can apply for funding,” she told this news organization. “We want to fund the best research.”
Because the funding is provided under the defense bill, there will be discussions around the military relevance of research, she added, which not only includes service members but also their families.
CDMRP anticipates that funding opportunities through this new arthritis research program will be available by July or August 2024.
A version of this article appeared on Medscape.com.
Tuberculosis Screening Gaps Persist in New DMARD Users
TOPLINE:
The rates of screening for latent tuberculosis remain suboptimal among new users of biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), with notable variations by medication type and demographic characteristics.
METHODOLOGY:
- Professional society guidelines recommend screening for tuberculosis before starting treatment with most b/tsDMARDs.
- In an attempt to estimate the extent of latent tuberculosis screening, researchers combined claims and electronic health record datasets to evaluate 2853 new b/tsDMARD users (mean age, 73 years; 72% women; and 73% non-Hispanic White).
- The primary analysis focused on assessing the proportion of patients screened for latent tuberculosis in the year before starting a new b/tsDMARD.
- A sensitivity analysis evaluated the extent of screening within the 3 years preceding the initiation of a new b/tsDMARD.
- A total of 65.6% of patients received screening for latent tuberculosis in the year before initiating a new b/tsDMARD.
- Screening rates improved only slightly on expanding the window to 3 years, with 72.9% of patients receiving any tuberculosis screening.
- When stratified by drug type, over half of new users of Janus kinase inhibitors and nearly 90% of new users of interleukin-17 inhibitors had not received screening.
- Hispanic patients had lower odds of tuberculosis screening within 1 year than White patients (odds ratio [OR], 0.64; 95% CI, 0.46-0.90), as did those in the highest socioeconomic quartile, compared with the lowest (OR, 0.61; 95% CI, 0.40-0.94).
IN PRACTICE:
“Educational initiatives, team-based care delivery, task shifting, and technological interventions to address observed gaps in patient safety procedures are needed,” the authors wrote.
SOURCE:
The study was led by Eric T. Roberts, PhD, University of California, San Francisco, and published online in Arthritis Care & Research
LIMITATIONS:
The study lacked access to scanned documents or clinical notes, which may have resulted in the omission of a small number of tests that had no Medicare billing. Moreover, the study was restricted to a 3-year lookback period, potentially missing some remote screenings. The findings may have limited generalizability to younger patients or those not dually eligible for Medicare and Medicaid.
DISCLOSURES:
This study was funded by grants from the Agency for Healthcare Research and Quality and the National Institute for Arthritis and Musculoskeletal and Skin Diseases. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
The rates of screening for latent tuberculosis remain suboptimal among new users of biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), with notable variations by medication type and demographic characteristics.
METHODOLOGY:
- Professional society guidelines recommend screening for tuberculosis before starting treatment with most b/tsDMARDs.
- In an attempt to estimate the extent of latent tuberculosis screening, researchers combined claims and electronic health record datasets to evaluate 2853 new b/tsDMARD users (mean age, 73 years; 72% women; and 73% non-Hispanic White).
- The primary analysis focused on assessing the proportion of patients screened for latent tuberculosis in the year before starting a new b/tsDMARD.
- A sensitivity analysis evaluated the extent of screening within the 3 years preceding the initiation of a new b/tsDMARD.
- A total of 65.6% of patients received screening for latent tuberculosis in the year before initiating a new b/tsDMARD.
- Screening rates improved only slightly on expanding the window to 3 years, with 72.9% of patients receiving any tuberculosis screening.
- When stratified by drug type, over half of new users of Janus kinase inhibitors and nearly 90% of new users of interleukin-17 inhibitors had not received screening.
- Hispanic patients had lower odds of tuberculosis screening within 1 year than White patients (odds ratio [OR], 0.64; 95% CI, 0.46-0.90), as did those in the highest socioeconomic quartile, compared with the lowest (OR, 0.61; 95% CI, 0.40-0.94).
IN PRACTICE:
“Educational initiatives, team-based care delivery, task shifting, and technological interventions to address observed gaps in patient safety procedures are needed,” the authors wrote.
SOURCE:
The study was led by Eric T. Roberts, PhD, University of California, San Francisco, and published online in Arthritis Care & Research
LIMITATIONS:
The study lacked access to scanned documents or clinical notes, which may have resulted in the omission of a small number of tests that had no Medicare billing. Moreover, the study was restricted to a 3-year lookback period, potentially missing some remote screenings. The findings may have limited generalizability to younger patients or those not dually eligible for Medicare and Medicaid.
DISCLOSURES:
This study was funded by grants from the Agency for Healthcare Research and Quality and the National Institute for Arthritis and Musculoskeletal and Skin Diseases. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
The rates of screening for latent tuberculosis remain suboptimal among new users of biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), with notable variations by medication type and demographic characteristics.
METHODOLOGY:
- Professional society guidelines recommend screening for tuberculosis before starting treatment with most b/tsDMARDs.
- In an attempt to estimate the extent of latent tuberculosis screening, researchers combined claims and electronic health record datasets to evaluate 2853 new b/tsDMARD users (mean age, 73 years; 72% women; and 73% non-Hispanic White).
- The primary analysis focused on assessing the proportion of patients screened for latent tuberculosis in the year before starting a new b/tsDMARD.
- A sensitivity analysis evaluated the extent of screening within the 3 years preceding the initiation of a new b/tsDMARD.
- A total of 65.6% of patients received screening for latent tuberculosis in the year before initiating a new b/tsDMARD.
- Screening rates improved only slightly on expanding the window to 3 years, with 72.9% of patients receiving any tuberculosis screening.
- When stratified by drug type, over half of new users of Janus kinase inhibitors and nearly 90% of new users of interleukin-17 inhibitors had not received screening.
- Hispanic patients had lower odds of tuberculosis screening within 1 year than White patients (odds ratio [OR], 0.64; 95% CI, 0.46-0.90), as did those in the highest socioeconomic quartile, compared with the lowest (OR, 0.61; 95% CI, 0.40-0.94).
IN PRACTICE:
“Educational initiatives, team-based care delivery, task shifting, and technological interventions to address observed gaps in patient safety procedures are needed,” the authors wrote.
SOURCE:
The study was led by Eric T. Roberts, PhD, University of California, San Francisco, and published online in Arthritis Care & Research
LIMITATIONS:
The study lacked access to scanned documents or clinical notes, which may have resulted in the omission of a small number of tests that had no Medicare billing. Moreover, the study was restricted to a 3-year lookback period, potentially missing some remote screenings. The findings may have limited generalizability to younger patients or those not dually eligible for Medicare and Medicaid.
DISCLOSURES:
This study was funded by grants from the Agency for Healthcare Research and Quality and the National Institute for Arthritis and Musculoskeletal and Skin Diseases. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
Commentary: Gut Dysbiosis, DMARD, Joint Involvement, and MACE in PsA, April 2024
After PsA onset, early diagnosis and management leads to better long-term outcomes. These prior observations were confirmed in a study by Snoeck Henkemans and colleagues that included 708 newly diagnosed patients with PsA naive to disease-modifying antirheumatic drugs (DMARD) who were followed up for 3 years or more. Patients with a short (<12 weeks) vs long delay (>1 year) in PsA diagnosis after symptom onset were more likely to achieve minimum disease activity (OR 2.55; 95% CI 1.37-4.76). Thus, longer delay in diagnosing PsA is associated with worse clinical outcomes.
Bimekizumab is a novel biologic therapy that inhibits interleukins (IL)-17A and -17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. However, the effectiveness in PsA vis-à-vis other IL-17A inhibitors is not known. In the absence of a formal head-to-head study, matching-adjusted indirect comparisons is a method to evaluate comparative effectiveness. Such a study by Mease and colleagues included the data of patients with PsA who were biological DMARD–naive or who had an inadequate response to tumor necrosis factor inhibitors (TNFi-IR), and who received bimekizumab from the BE OPTIMAL (n = 236) and BE COMPLETE (n = 146) trials and secukinumab from the FUTURE 2 trial (n = 200). They demonstrated that, in the biological DMARD–naive subgroup, the probability of achieving at least 70% improvement in American College of Rheumatology (ACR) response was two times higher with bimekizumab (160 mg every 4 weeks) vs secukinumab (150 mg or 300 mg every 4 weeks) at week 52. In the TNFi-IR subgroup, bimekizumab had a greater likelihood of response compared with 150 mg secukinumab for ACR20, ACR70, and minimal disease activity outcomes and a greater likelihood of response compared with 300 mg secukinumab for ACR50 and minimal disease activity. Thus, bimekizumab is at least as effective as secukinumab in PsA. Formal head-to-head studies comparing bimekizumab with other IL-17A inhibitors are required.
Distal interphalangeal (DIP) joint involvement is an important manifestation of PsA and is closely related to nail dystrophy in the adjacent nail. Ixekizumab is another biologic that targets IL-17A. In a post hoc analysis of the SPIRIT-H2H study, McGonagle and colleagues confirmed that over 96% of patients with PsA and simultaneous DIP joint involvement reported adjacent nail psoriasis. When compared with adalimumab, ixekizumab led to greater improvements in DIP involvement and adjacent nail psoriasis as early as week 12 (38.8% vs 28.4%; P < .0001), with improvements sustained up to week 52 (64.9% vs 57.5%; P = .0055). This probably reflects a greater effectiveness of IL-17A inhibition in treating skin and nail psoriasis compared with TNFi.
Finally, in a population-based retrospective cohort study that included 13,905 patients with PsA (n = 1672) or rheumatoid arthritis (n = 12,233) who did not have any previous history of major adverse cardiovascular events (MACE), Meng and colleagues showed that the incidence rates of MACE were similar in patients with PsA and rheumatoid arthritis. Thus, cardiovascular risk management should be similarly aggressive in patients with PsA and rheumatoid arthritis.
After PsA onset, early diagnosis and management leads to better long-term outcomes. These prior observations were confirmed in a study by Snoeck Henkemans and colleagues that included 708 newly diagnosed patients with PsA naive to disease-modifying antirheumatic drugs (DMARD) who were followed up for 3 years or more. Patients with a short (<12 weeks) vs long delay (>1 year) in PsA diagnosis after symptom onset were more likely to achieve minimum disease activity (OR 2.55; 95% CI 1.37-4.76). Thus, longer delay in diagnosing PsA is associated with worse clinical outcomes.
Bimekizumab is a novel biologic therapy that inhibits interleukins (IL)-17A and -17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. However, the effectiveness in PsA vis-à-vis other IL-17A inhibitors is not known. In the absence of a formal head-to-head study, matching-adjusted indirect comparisons is a method to evaluate comparative effectiveness. Such a study by Mease and colleagues included the data of patients with PsA who were biological DMARD–naive or who had an inadequate response to tumor necrosis factor inhibitors (TNFi-IR), and who received bimekizumab from the BE OPTIMAL (n = 236) and BE COMPLETE (n = 146) trials and secukinumab from the FUTURE 2 trial (n = 200). They demonstrated that, in the biological DMARD–naive subgroup, the probability of achieving at least 70% improvement in American College of Rheumatology (ACR) response was two times higher with bimekizumab (160 mg every 4 weeks) vs secukinumab (150 mg or 300 mg every 4 weeks) at week 52. In the TNFi-IR subgroup, bimekizumab had a greater likelihood of response compared with 150 mg secukinumab for ACR20, ACR70, and minimal disease activity outcomes and a greater likelihood of response compared with 300 mg secukinumab for ACR50 and minimal disease activity. Thus, bimekizumab is at least as effective as secukinumab in PsA. Formal head-to-head studies comparing bimekizumab with other IL-17A inhibitors are required.
Distal interphalangeal (DIP) joint involvement is an important manifestation of PsA and is closely related to nail dystrophy in the adjacent nail. Ixekizumab is another biologic that targets IL-17A. In a post hoc analysis of the SPIRIT-H2H study, McGonagle and colleagues confirmed that over 96% of patients with PsA and simultaneous DIP joint involvement reported adjacent nail psoriasis. When compared with adalimumab, ixekizumab led to greater improvements in DIP involvement and adjacent nail psoriasis as early as week 12 (38.8% vs 28.4%; P < .0001), with improvements sustained up to week 52 (64.9% vs 57.5%; P = .0055). This probably reflects a greater effectiveness of IL-17A inhibition in treating skin and nail psoriasis compared with TNFi.
Finally, in a population-based retrospective cohort study that included 13,905 patients with PsA (n = 1672) or rheumatoid arthritis (n = 12,233) who did not have any previous history of major adverse cardiovascular events (MACE), Meng and colleagues showed that the incidence rates of MACE were similar in patients with PsA and rheumatoid arthritis. Thus, cardiovascular risk management should be similarly aggressive in patients with PsA and rheumatoid arthritis.
After PsA onset, early diagnosis and management leads to better long-term outcomes. These prior observations were confirmed in a study by Snoeck Henkemans and colleagues that included 708 newly diagnosed patients with PsA naive to disease-modifying antirheumatic drugs (DMARD) who were followed up for 3 years or more. Patients with a short (<12 weeks) vs long delay (>1 year) in PsA diagnosis after symptom onset were more likely to achieve minimum disease activity (OR 2.55; 95% CI 1.37-4.76). Thus, longer delay in diagnosing PsA is associated with worse clinical outcomes.
Bimekizumab is a novel biologic therapy that inhibits interleukins (IL)-17A and -17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. However, the effectiveness in PsA vis-à-vis other IL-17A inhibitors is not known. In the absence of a formal head-to-head study, matching-adjusted indirect comparisons is a method to evaluate comparative effectiveness. Such a study by Mease and colleagues included the data of patients with PsA who were biological DMARD–naive or who had an inadequate response to tumor necrosis factor inhibitors (TNFi-IR), and who received bimekizumab from the BE OPTIMAL (n = 236) and BE COMPLETE (n = 146) trials and secukinumab from the FUTURE 2 trial (n = 200). They demonstrated that, in the biological DMARD–naive subgroup, the probability of achieving at least 70% improvement in American College of Rheumatology (ACR) response was two times higher with bimekizumab (160 mg every 4 weeks) vs secukinumab (150 mg or 300 mg every 4 weeks) at week 52. In the TNFi-IR subgroup, bimekizumab had a greater likelihood of response compared with 150 mg secukinumab for ACR20, ACR70, and minimal disease activity outcomes and a greater likelihood of response compared with 300 mg secukinumab for ACR50 and minimal disease activity. Thus, bimekizumab is at least as effective as secukinumab in PsA. Formal head-to-head studies comparing bimekizumab with other IL-17A inhibitors are required.
Distal interphalangeal (DIP) joint involvement is an important manifestation of PsA and is closely related to nail dystrophy in the adjacent nail. Ixekizumab is another biologic that targets IL-17A. In a post hoc analysis of the SPIRIT-H2H study, McGonagle and colleagues confirmed that over 96% of patients with PsA and simultaneous DIP joint involvement reported adjacent nail psoriasis. When compared with adalimumab, ixekizumab led to greater improvements in DIP involvement and adjacent nail psoriasis as early as week 12 (38.8% vs 28.4%; P < .0001), with improvements sustained up to week 52 (64.9% vs 57.5%; P = .0055). This probably reflects a greater effectiveness of IL-17A inhibition in treating skin and nail psoriasis compared with TNFi.
Finally, in a population-based retrospective cohort study that included 13,905 patients with PsA (n = 1672) or rheumatoid arthritis (n = 12,233) who did not have any previous history of major adverse cardiovascular events (MACE), Meng and colleagues showed that the incidence rates of MACE were similar in patients with PsA and rheumatoid arthritis. Thus, cardiovascular risk management should be similarly aggressive in patients with PsA and rheumatoid arthritis.
Europe’s Quest for Earlier Diagnosis of Psoriatic Arthritis
An estimated 3% of the world’s population have psoriasis, with approximately 6.4 million people across Europe affected. Almost one third of people with psoriasis will develop psoriatic arthritis (PsA), a disease that can be severe and debilitating and lead to irreversible degeneration of bone and tissue, typically affecting the joints of hands and feet.
As inflammatory autoimmune diseases, psoriasis and PsA also increase the risk for further comorbidities, such as cardiovascular diseases and obesity, with higher rates of depression among those affected.
“Another key unmet need relates to whether we can reliably identify risk factors for which a person with psoriasis will develop PsA. We know that 30% will develop PsA, but we cannot identify which person with psoriasis is at risk,” said Professor Oliver FitzGerald of University College Dublin (UCD), Dublin, Ireland, an international opinion leader in rheumatology. A clearer understanding of PsA could lead to development of tools for its early diagnosis and identification of disease prevention strategies, he explained.
Thus, HIPPOCRATES (Health Initiatives in Psoriasis and Psoriatic Arthritis Consortium European States ) was created. This ambitious research consortium was conceived by Dr. FitzGerald and his colleague Stephen Pennington, professor of proteomics at UCD, together with a number of likeminded colleagues in the fields of rheumatology and dermatology and at organizations such as GRAPPA, HUPO, EULAR, and EUROPSO.
The collaboration has brought together world-leading clinicians, researchers, and people living with psoriasis and PsA to address the main challenges in its early identification and management.
HIPPOCRATES received €23.5 million in funding from the EU Innovative Medicines Initiative public-private partnership in 2021 and is now half way through its 5-year plan.
Key Goals
HIPPOCRATES involves 27 partners, including from industry, in 11 countries.
Its four key goals are:
- Identifying specific PsA disease markers to develop accurate diagnostic tools;
- Developing prediction strategies to identify which person with psoriasis will develop PsA;
- Monitoring and prevention of PsA disease progression to irreversible joint damage; and
- Identifying personalized treatment options, so that patients are treated with the right medicines for their specific disease.
“The pharmaceutical companies have come up with a veritable armory of potential treatments, but rheumatologists still don’t know which one to use for a particular patient at a particular time,” Dr. Pennington explained to this news organization. “So the reality is they tend to cycle through treatments until they find one that is effective.” This is not very efficient or desirable for patients, he added.
Multidisciplinary Approach
A key advantage of HIPPOCRATES is that it brings several medical disciplines together. The current approach of clinicians working in silos is a key barrier to earlier diagnosis of PsA.
“The reality is that a patient with psoriasis will see a dermatologist, and dermatologists don’t necessarily have the skills or training to identify the very early stages of psoriatic arthritis, so they will only refer a patient of theirs to a rheumatologist at a very late stage,” said Dr. Pennington.
Dermatologists need better tools to be able to recognize when they should refer their psoriasis patients to rheumatologists, so that patients developing PsA are diagnosed and treated earlier, he explained.
GPs will also be an important component of the project because they are the first point of healthcare contact for people with PsA or psoriasis.
“[I]t is about helping GPs diagnose earlier and raise awareness among patients. Historically, there has been a bit of a lag between people having their first symptoms and getting a diagnosis,” explained HIPPOCRATES collaborator Frances Mair, the Norie Miller Professor of General Practice and head of general practice and primary care at the University of Glasgow, Glasgow, Scotland.
Dr. Mair said that diagnosis isn't always straightforward, and the hope is that the study will identify more specific risk factors that will help GPs flag PsA earlier.
Patient Involvement and Data Sharing
The HIPPOCRATES consortium involves patients in all stages of the project.
“In HIPPOCRATES, patient and public involvement is really a central feature, which is quite unusual at the more experimental side of healthcare and research. In HIPPOCRATES, the patient research partners have a leading role, making a real difference…” said Dr. Mair.
To facilitate its goals, the consortium partners are sharing data and samples from previously conducted studies on psoriasis and PsA populations. This will facilitate extensive omics-based analyses to establish and validate robust biomarkers across datasets, using the latest cutting-edge techniques, including machine learning and artificial intelligence.
In addition, the HIPPOCRATES Prospective Observational Study (HPOS) was launched last year. This web-based study aims to recruit 25,000 adults (≥ 18 years of age) with skin psoriasis across Europe. They will collect their clinical data every 6 months, including emerging musculoskeletal symptoms. Blood samples will also be collected remotely from a subset of 3000 participants using a finger-prick kit that will be posted to their homes.
HPOS has already commenced recruitment in the UK, Ireland and, most recently, Greece and Portugal, with nearly 2300 participants enrolled to date. HPOS also plans to launch in France, Italy, Spain, Denmark, Germany, Belgium, the Netherlands, and Sweden.
“This ambitious study will give us the statistical power to identify clinical/molecular risk factors for progression from psoriasis to PsA. We anticipate that 675 participants per year will develop PsA in our studied population. Participants will receive regular feedback to help monitor their condition, and we will help them to get the medical care that they need,” said Dr. FitzGerald.
Dr. Pennington added that the consortium believes it is a “realistic goal” that the resulting molecular risk prediction tools could eventually enable clinicians to intervene to prevent PsA.
From Research to Practice
The HIPPOCRATES projects are making good progress, with several early publications, and further publications being drafted.
“One of the biggest achievements so far has been to assemble this massive resource of patient samples — tens of thousands in total in a single integrated database, which is the foundation of the project,” said Dr. Pennington. He explained that it took a significant amount of work to secure the necessary agreements from all 27 partners to share the patient data securely, appropriately, and anonymously within the consortium.
Creating successful biomarkers, algorithms, and other tools is one thing, but disseminating the knowledge learned and rolling out the final agreed guidelines will be just as important as the research work, said Dr. Pennington.
Dr. Mair, who is responsible for promoting communication, dissemination, and maximizing the impact of the research undertaken by the HIPPOCRATES consortium, said: “We see so often in healthcare that people come with great ideas or tools, yet they don’t become part of everyday practice. Hence, I am working on the implementation side of HIPPOCRATES, to make sure its findings will be embedded and routinely used in practice,” she said.
A version of this article appeared on Medscape.com.
An estimated 3% of the world’s population have psoriasis, with approximately 6.4 million people across Europe affected. Almost one third of people with psoriasis will develop psoriatic arthritis (PsA), a disease that can be severe and debilitating and lead to irreversible degeneration of bone and tissue, typically affecting the joints of hands and feet.
As inflammatory autoimmune diseases, psoriasis and PsA also increase the risk for further comorbidities, such as cardiovascular diseases and obesity, with higher rates of depression among those affected.
“Another key unmet need relates to whether we can reliably identify risk factors for which a person with psoriasis will develop PsA. We know that 30% will develop PsA, but we cannot identify which person with psoriasis is at risk,” said Professor Oliver FitzGerald of University College Dublin (UCD), Dublin, Ireland, an international opinion leader in rheumatology. A clearer understanding of PsA could lead to development of tools for its early diagnosis and identification of disease prevention strategies, he explained.
Thus, HIPPOCRATES (Health Initiatives in Psoriasis and Psoriatic Arthritis Consortium European States ) was created. This ambitious research consortium was conceived by Dr. FitzGerald and his colleague Stephen Pennington, professor of proteomics at UCD, together with a number of likeminded colleagues in the fields of rheumatology and dermatology and at organizations such as GRAPPA, HUPO, EULAR, and EUROPSO.
The collaboration has brought together world-leading clinicians, researchers, and people living with psoriasis and PsA to address the main challenges in its early identification and management.
HIPPOCRATES received €23.5 million in funding from the EU Innovative Medicines Initiative public-private partnership in 2021 and is now half way through its 5-year plan.
Key Goals
HIPPOCRATES involves 27 partners, including from industry, in 11 countries.
Its four key goals are:
- Identifying specific PsA disease markers to develop accurate diagnostic tools;
- Developing prediction strategies to identify which person with psoriasis will develop PsA;
- Monitoring and prevention of PsA disease progression to irreversible joint damage; and
- Identifying personalized treatment options, so that patients are treated with the right medicines for their specific disease.
“The pharmaceutical companies have come up with a veritable armory of potential treatments, but rheumatologists still don’t know which one to use for a particular patient at a particular time,” Dr. Pennington explained to this news organization. “So the reality is they tend to cycle through treatments until they find one that is effective.” This is not very efficient or desirable for patients, he added.
Multidisciplinary Approach
A key advantage of HIPPOCRATES is that it brings several medical disciplines together. The current approach of clinicians working in silos is a key barrier to earlier diagnosis of PsA.
“The reality is that a patient with psoriasis will see a dermatologist, and dermatologists don’t necessarily have the skills or training to identify the very early stages of psoriatic arthritis, so they will only refer a patient of theirs to a rheumatologist at a very late stage,” said Dr. Pennington.
Dermatologists need better tools to be able to recognize when they should refer their psoriasis patients to rheumatologists, so that patients developing PsA are diagnosed and treated earlier, he explained.
GPs will also be an important component of the project because they are the first point of healthcare contact for people with PsA or psoriasis.
“[I]t is about helping GPs diagnose earlier and raise awareness among patients. Historically, there has been a bit of a lag between people having their first symptoms and getting a diagnosis,” explained HIPPOCRATES collaborator Frances Mair, the Norie Miller Professor of General Practice and head of general practice and primary care at the University of Glasgow, Glasgow, Scotland.
Dr. Mair said that diagnosis isn't always straightforward, and the hope is that the study will identify more specific risk factors that will help GPs flag PsA earlier.
Patient Involvement and Data Sharing
The HIPPOCRATES consortium involves patients in all stages of the project.
“In HIPPOCRATES, patient and public involvement is really a central feature, which is quite unusual at the more experimental side of healthcare and research. In HIPPOCRATES, the patient research partners have a leading role, making a real difference…” said Dr. Mair.
To facilitate its goals, the consortium partners are sharing data and samples from previously conducted studies on psoriasis and PsA populations. This will facilitate extensive omics-based analyses to establish and validate robust biomarkers across datasets, using the latest cutting-edge techniques, including machine learning and artificial intelligence.
In addition, the HIPPOCRATES Prospective Observational Study (HPOS) was launched last year. This web-based study aims to recruit 25,000 adults (≥ 18 years of age) with skin psoriasis across Europe. They will collect their clinical data every 6 months, including emerging musculoskeletal symptoms. Blood samples will also be collected remotely from a subset of 3000 participants using a finger-prick kit that will be posted to their homes.
HPOS has already commenced recruitment in the UK, Ireland and, most recently, Greece and Portugal, with nearly 2300 participants enrolled to date. HPOS also plans to launch in France, Italy, Spain, Denmark, Germany, Belgium, the Netherlands, and Sweden.
“This ambitious study will give us the statistical power to identify clinical/molecular risk factors for progression from psoriasis to PsA. We anticipate that 675 participants per year will develop PsA in our studied population. Participants will receive regular feedback to help monitor their condition, and we will help them to get the medical care that they need,” said Dr. FitzGerald.
Dr. Pennington added that the consortium believes it is a “realistic goal” that the resulting molecular risk prediction tools could eventually enable clinicians to intervene to prevent PsA.
From Research to Practice
The HIPPOCRATES projects are making good progress, with several early publications, and further publications being drafted.
“One of the biggest achievements so far has been to assemble this massive resource of patient samples — tens of thousands in total in a single integrated database, which is the foundation of the project,” said Dr. Pennington. He explained that it took a significant amount of work to secure the necessary agreements from all 27 partners to share the patient data securely, appropriately, and anonymously within the consortium.
Creating successful biomarkers, algorithms, and other tools is one thing, but disseminating the knowledge learned and rolling out the final agreed guidelines will be just as important as the research work, said Dr. Pennington.
Dr. Mair, who is responsible for promoting communication, dissemination, and maximizing the impact of the research undertaken by the HIPPOCRATES consortium, said: “We see so often in healthcare that people come with great ideas or tools, yet they don’t become part of everyday practice. Hence, I am working on the implementation side of HIPPOCRATES, to make sure its findings will be embedded and routinely used in practice,” she said.
A version of this article appeared on Medscape.com.
An estimated 3% of the world’s population have psoriasis, with approximately 6.4 million people across Europe affected. Almost one third of people with psoriasis will develop psoriatic arthritis (PsA), a disease that can be severe and debilitating and lead to irreversible degeneration of bone and tissue, typically affecting the joints of hands and feet.
As inflammatory autoimmune diseases, psoriasis and PsA also increase the risk for further comorbidities, such as cardiovascular diseases and obesity, with higher rates of depression among those affected.
“Another key unmet need relates to whether we can reliably identify risk factors for which a person with psoriasis will develop PsA. We know that 30% will develop PsA, but we cannot identify which person with psoriasis is at risk,” said Professor Oliver FitzGerald of University College Dublin (UCD), Dublin, Ireland, an international opinion leader in rheumatology. A clearer understanding of PsA could lead to development of tools for its early diagnosis and identification of disease prevention strategies, he explained.
Thus, HIPPOCRATES (Health Initiatives in Psoriasis and Psoriatic Arthritis Consortium European States ) was created. This ambitious research consortium was conceived by Dr. FitzGerald and his colleague Stephen Pennington, professor of proteomics at UCD, together with a number of likeminded colleagues in the fields of rheumatology and dermatology and at organizations such as GRAPPA, HUPO, EULAR, and EUROPSO.
The collaboration has brought together world-leading clinicians, researchers, and people living with psoriasis and PsA to address the main challenges in its early identification and management.
HIPPOCRATES received €23.5 million in funding from the EU Innovative Medicines Initiative public-private partnership in 2021 and is now half way through its 5-year plan.
Key Goals
HIPPOCRATES involves 27 partners, including from industry, in 11 countries.
Its four key goals are:
- Identifying specific PsA disease markers to develop accurate diagnostic tools;
- Developing prediction strategies to identify which person with psoriasis will develop PsA;
- Monitoring and prevention of PsA disease progression to irreversible joint damage; and
- Identifying personalized treatment options, so that patients are treated with the right medicines for their specific disease.
“The pharmaceutical companies have come up with a veritable armory of potential treatments, but rheumatologists still don’t know which one to use for a particular patient at a particular time,” Dr. Pennington explained to this news organization. “So the reality is they tend to cycle through treatments until they find one that is effective.” This is not very efficient or desirable for patients, he added.
Multidisciplinary Approach
A key advantage of HIPPOCRATES is that it brings several medical disciplines together. The current approach of clinicians working in silos is a key barrier to earlier diagnosis of PsA.
“The reality is that a patient with psoriasis will see a dermatologist, and dermatologists don’t necessarily have the skills or training to identify the very early stages of psoriatic arthritis, so they will only refer a patient of theirs to a rheumatologist at a very late stage,” said Dr. Pennington.
Dermatologists need better tools to be able to recognize when they should refer their psoriasis patients to rheumatologists, so that patients developing PsA are diagnosed and treated earlier, he explained.
GPs will also be an important component of the project because they are the first point of healthcare contact for people with PsA or psoriasis.
“[I]t is about helping GPs diagnose earlier and raise awareness among patients. Historically, there has been a bit of a lag between people having their first symptoms and getting a diagnosis,” explained HIPPOCRATES collaborator Frances Mair, the Norie Miller Professor of General Practice and head of general practice and primary care at the University of Glasgow, Glasgow, Scotland.
Dr. Mair said that diagnosis isn't always straightforward, and the hope is that the study will identify more specific risk factors that will help GPs flag PsA earlier.
Patient Involvement and Data Sharing
The HIPPOCRATES consortium involves patients in all stages of the project.
“In HIPPOCRATES, patient and public involvement is really a central feature, which is quite unusual at the more experimental side of healthcare and research. In HIPPOCRATES, the patient research partners have a leading role, making a real difference…” said Dr. Mair.
To facilitate its goals, the consortium partners are sharing data and samples from previously conducted studies on psoriasis and PsA populations. This will facilitate extensive omics-based analyses to establish and validate robust biomarkers across datasets, using the latest cutting-edge techniques, including machine learning and artificial intelligence.
In addition, the HIPPOCRATES Prospective Observational Study (HPOS) was launched last year. This web-based study aims to recruit 25,000 adults (≥ 18 years of age) with skin psoriasis across Europe. They will collect their clinical data every 6 months, including emerging musculoskeletal symptoms. Blood samples will also be collected remotely from a subset of 3000 participants using a finger-prick kit that will be posted to their homes.
HPOS has already commenced recruitment in the UK, Ireland and, most recently, Greece and Portugal, with nearly 2300 participants enrolled to date. HPOS also plans to launch in France, Italy, Spain, Denmark, Germany, Belgium, the Netherlands, and Sweden.
“This ambitious study will give us the statistical power to identify clinical/molecular risk factors for progression from psoriasis to PsA. We anticipate that 675 participants per year will develop PsA in our studied population. Participants will receive regular feedback to help monitor their condition, and we will help them to get the medical care that they need,” said Dr. FitzGerald.
Dr. Pennington added that the consortium believes it is a “realistic goal” that the resulting molecular risk prediction tools could eventually enable clinicians to intervene to prevent PsA.
From Research to Practice
The HIPPOCRATES projects are making good progress, with several early publications, and further publications being drafted.
“One of the biggest achievements so far has been to assemble this massive resource of patient samples — tens of thousands in total in a single integrated database, which is the foundation of the project,” said Dr. Pennington. He explained that it took a significant amount of work to secure the necessary agreements from all 27 partners to share the patient data securely, appropriately, and anonymously within the consortium.
Creating successful biomarkers, algorithms, and other tools is one thing, but disseminating the knowledge learned and rolling out the final agreed guidelines will be just as important as the research work, said Dr. Pennington.
Dr. Mair, who is responsible for promoting communication, dissemination, and maximizing the impact of the research undertaken by the HIPPOCRATES consortium, said: “We see so often in healthcare that people come with great ideas or tools, yet they don’t become part of everyday practice. Hence, I am working on the implementation side of HIPPOCRATES, to make sure its findings will be embedded and routinely used in practice,” she said.
A version of this article appeared on Medscape.com.
Multiple Social Disadvantages Linked to Progressively Worse JIA and Pediatric Lupus
The accumulation of multiple adverse social determinants of health is linked to worse disease at initial presentation and worse disease activity over time in children with rheumatologic conditions, according to findings presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance.
One study revealed that cumulative factors conferring social disadvantage progressively increased the odds of active disease and functional disability in children with juvenile idiopathic arthritis (JIA). Another study similarly found that children with lupus living in neighborhoods with comparatively fewer resources for childhood opportunity had worse disease at presentation and greater disease activity over follow-up.
, William Daniel Soulsby, MD, of the University of California San Francisco, told attendees in his presentation of data from the JIA study.
“Most prior studies have analyzed such determinants as independent risk factors,” Dr. Soulsby said. “However, individuals experiencing social disadvantage often face multiple social hardships that rarely act in isolation; studying these factors independently may miss underlying disparities.”
Stacy P. Ardoin, MD, MSc, professor of pediatric and adult rheumatology at Nationwide Children’s Hospital and The Ohio State University in Columbus, and vice president of CARRA, did not find the results of Soulsby’s study surprising, but she said they do “provide important confirmation of our growing understanding of the impact of social determinants of health on the outcomes of children and adolescents with chronic disease like juvenile idiopathic arthritis.” She added: “In medicine, we often think about the bench, the bedside, and the clinic, but this study tells us that if we want to improve outcomes for our patients, we also need to think about the ‘backyard,’ too.”
Social Disadvantage With JIA
Dr. Soulsby’s team adopted an approach similar to that of a recent National Survey of Children’s Health analysis that used a combined scoring system to calculate cumulative social disadvantage. The researchers used income level, insurance status, and education level to capture individual factors related to disadvantage and then an area deprivation index (ADI) to capture community factors. While they were unable to use any variables specific to societal factors, they included race, which is relevant at all three levels.
The cohort included 9612 patients in the CARRA Registry from July 2015 to January 2022. They included all patients who had a JIA diagnosis with onset before age 16 and at least one visit with a complete clinical Juvenile Arthritis Disease Activity Score (JADAS) score. Most of the patients (70%) were female, with an average age at enrollment of 11 and a mean time to diagnosis of 10.6 months.
Most of the patients had oligoarthritis (35.5%) or rheumatoid factor–negative polyarthritis (29.4%), followed by enthesitis-related arthritis (10.5%) and then other forms. A total of 4% of patients had a secondary rheumatologic condition. Most of the patients were White (74.9%), with 3.9% Black, 7.6% Hispanic, and 6.5% of more than one race. ADI data were missing for 17.2% of patients.
The researchers assigned a score to each patient that could add up to a maximum of 3. They received 1 point for an annual household income below $50,000, 1 point for having public insurance or no insurance, and 1 point for their guardian having no more than a high school education. Patients with a score of 0 comprised 60.9% of the patients, while 21.3% had a score of 1, 12.9% had a score of 2, and 4.9% had a score of 3.
Just over a quarter of the patients (26.3%) were underinsured, 19.1% were low income, and 16.4% had caregivers with a high school education or less. However, income level was unknown for 24.6% of patients, and guardians’ education level was unknown for 15.7% of patients.
The primary outcomes were the odds of active disease as based on clinical JADAS (at least a 1.1 score for oligoarticular JIA and more than 2.5 for all other subtypes) and odds of functional disability based on the Childhood Health Assessment Questionnaire (CHAQ). Adjustments were made for sex, race/ethnicity, age at enrollment, time to diagnosis, ADI, JIA category, presence of secondary rheumatologic disease, and medication (use of a conventional synthetic disease-modifying antirheumatic drug [DMARD], biologic DMARD, or small molecule drug).
Nearly half (48%) of patients had active disease during follow-up, with an average clinical JADAS score of 4 from the whole cohort. Compared with children with a cumulative disadvantage score of 0, each additional point on the clinical JADAS resulted in significantly increased odds of active disease. Those with the highest score of 3 were twice as likely to have active disease (adjusted odds ratio [aOR], 2.05; P < .001) as those with a score of 0, but those with a score of 1 (aOR, 1.36; P < .001) or 2 (aOR, 1.86; P < .001) were also more likely to have active disease. Other significant independent predictors of active arthritis included being of Black race (aOR, 1.55) or more than one race (aOR, 1.31).
Each of the scored factors also independently increased the likelihood of active disease by similar amounts: 1.69 higher odds for low household income on its own, 1.6 higher odds for public or no insurance, and 1.45 higher odds for high school education or less (all P < .001).
Similarly, odds of functional disability based on CHAQ increased significantly with each additional point. The mean CHAQ score was 0.31, and 46% of patients had functional disability during follow-up. Those with a cumulative social disadvantage score of 3 were three times as likely to have functional disability (aOR, 3.09; P < .001) as those with a score of 0. Those with a score of 1 (aOR, 1.82) or 2 (aOR, 2.81) were also more likely to have functional disability (P < .001). Again, Black individuals (aOR, 2.09) or those of mixed race (aOR, 1.78) had greater odds of functional disability (P < .001).
The independent factor most associated with increased odds of functional disability was a household income below $50,000 a year (OR, 3.03; P < .001), followed by having public or no insurance (OR, 2.57) or a caregiver with no more than a high school education (OR, 1.98). Dr. Soulsby noted that their study was limited by the missing data and may oversimplify the relationships between social determinants of health.
Overall, however, the findings revealed both the importance of social risk screening in the pediatric rheumatology clinic and the coupling of that screening with individual level support for patients, Dr. Soulsby said.
“This study did a great job of harnessing the power of the CARRA Registry,” said Dr. Ardoin, who was not involved in the research. “These findings underscore how important it is for all clinicians, including pediatric rheumatologists, to evaluate every child for social risks of poor outcomes,” she said.
One take-home message from the findings is that once pediatric rheumatologists identify social risks for poor outcomes in their patients, they can “consult with social workers and connect families with community resources in an effort to ameliorate social deprivation.”
Childhood Lupus and Reduced Childhood Opportunity
In a similar study looking at children with childhood-onset lupus, researchers similarly identified the way that compounding social determinants of health were linked to greater disease activity.
“We know that structural racism segregates children from historically marginalized groups into different neighborhoods with lower childhood opportunity,” Joyce C. Chang, MD, of Boston Children’s Hospital, told attendees. “When we talk about child opportunity, we’re really describing all of the resources and conditions that helped to promote healthy childhood development,” including factors related to education, physical health, the built environment, and social and economic security, she said.
Dr. Chang and her colleagues therefore assessed the relationship between a 29-indicator Child Opportunity Index for patients with childhood-onset lupus and the severity of their disease presentation and activity over time. They determined the Child Opportunity Index for different neighborhoods and assessed the amount of racial residential segregation around the three institutions involved in the study. Severity of lupus presentation was based on the need for intensive care unit admission or dialysis or a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 10 or higher. Disease activity over time was based on the SLEDAI-2K score.
The patient population included 553 patients with childhood-onset lupus from three institutions: Boston Children’s Hospital, Lurie Children’s Hospital of Chicago, and Children’s of Alabama in Birmingham, Alabama. Across the full population, 30% of the patients were Black and 30% were Hispanic, but the distribution of race and ethnicity varied by institution. Most of the Black patients, for example, were at Children’s of Alabama (59%), while 43% of the Hispanic patients were at Lurie. Across all the sites, 14% of the patients’ families preferred a non-English language as their first language, and just over half the patients (52%) had public insurance.
Dr. Chang did not have data yet from the Lurie and Alabama cohorts, so she presented preliminary data from the Boston Children’s cohort of 148 patients. In those results, children living in neighborhoods of low childhood opportunity had four times higher odds of presenting with severe disease than children living in neighborhoods of very high opportunity. Then the researchers factored in the location quotient that represented the magnitude of racial segregation in a residential area. In areas with high levels of Black vs White segregation, children were 2.5 times more likely to have a more severe initial disease presentation. However, there was not a significant difference in areas highly segregated between Hispanic and non-Hispanic residents.
After initial presentation, the data revealed a dose-dependent relationship between childhood opportunity and severity of disease activity based on SLEDAI-2K. After adjustment for insurance status, race, preferred language, age at disease onset, sex, major organ involvement, initial SLEDAI-2K score at presentation, and follow-up time, disease activity incrementally increased as childhood opportunity decreased (P < .001 for the trend).
The findings suggested that even in regions like Boston, where overall childhood opportunity is higher than the national average, “poor relative neighborhood opportunity is still associated with more severe lupus presentation, as well as higher lupus disease activity during follow-up,” Dr. Chang said. “Area-level conditions may drive inequitable outcomes at numerous points,” including initial access to subspecialty care and after establishing that care, she said.
Dr. Soulsby, Dr. Chang, and Dr. Ardoin reported having no disclosures. Dr. Soulsby’s research was funded by CARRA and the Arthritis Foundation, and Dr. Chang’s research was funded by CARRA.
A version of this article appeared on Medscape.com.
The accumulation of multiple adverse social determinants of health is linked to worse disease at initial presentation and worse disease activity over time in children with rheumatologic conditions, according to findings presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance.
One study revealed that cumulative factors conferring social disadvantage progressively increased the odds of active disease and functional disability in children with juvenile idiopathic arthritis (JIA). Another study similarly found that children with lupus living in neighborhoods with comparatively fewer resources for childhood opportunity had worse disease at presentation and greater disease activity over follow-up.
, William Daniel Soulsby, MD, of the University of California San Francisco, told attendees in his presentation of data from the JIA study.
“Most prior studies have analyzed such determinants as independent risk factors,” Dr. Soulsby said. “However, individuals experiencing social disadvantage often face multiple social hardships that rarely act in isolation; studying these factors independently may miss underlying disparities.”
Stacy P. Ardoin, MD, MSc, professor of pediatric and adult rheumatology at Nationwide Children’s Hospital and The Ohio State University in Columbus, and vice president of CARRA, did not find the results of Soulsby’s study surprising, but she said they do “provide important confirmation of our growing understanding of the impact of social determinants of health on the outcomes of children and adolescents with chronic disease like juvenile idiopathic arthritis.” She added: “In medicine, we often think about the bench, the bedside, and the clinic, but this study tells us that if we want to improve outcomes for our patients, we also need to think about the ‘backyard,’ too.”
Social Disadvantage With JIA
Dr. Soulsby’s team adopted an approach similar to that of a recent National Survey of Children’s Health analysis that used a combined scoring system to calculate cumulative social disadvantage. The researchers used income level, insurance status, and education level to capture individual factors related to disadvantage and then an area deprivation index (ADI) to capture community factors. While they were unable to use any variables specific to societal factors, they included race, which is relevant at all three levels.
The cohort included 9612 patients in the CARRA Registry from July 2015 to January 2022. They included all patients who had a JIA diagnosis with onset before age 16 and at least one visit with a complete clinical Juvenile Arthritis Disease Activity Score (JADAS) score. Most of the patients (70%) were female, with an average age at enrollment of 11 and a mean time to diagnosis of 10.6 months.
Most of the patients had oligoarthritis (35.5%) or rheumatoid factor–negative polyarthritis (29.4%), followed by enthesitis-related arthritis (10.5%) and then other forms. A total of 4% of patients had a secondary rheumatologic condition. Most of the patients were White (74.9%), with 3.9% Black, 7.6% Hispanic, and 6.5% of more than one race. ADI data were missing for 17.2% of patients.
The researchers assigned a score to each patient that could add up to a maximum of 3. They received 1 point for an annual household income below $50,000, 1 point for having public insurance or no insurance, and 1 point for their guardian having no more than a high school education. Patients with a score of 0 comprised 60.9% of the patients, while 21.3% had a score of 1, 12.9% had a score of 2, and 4.9% had a score of 3.
Just over a quarter of the patients (26.3%) were underinsured, 19.1% were low income, and 16.4% had caregivers with a high school education or less. However, income level was unknown for 24.6% of patients, and guardians’ education level was unknown for 15.7% of patients.
The primary outcomes were the odds of active disease as based on clinical JADAS (at least a 1.1 score for oligoarticular JIA and more than 2.5 for all other subtypes) and odds of functional disability based on the Childhood Health Assessment Questionnaire (CHAQ). Adjustments were made for sex, race/ethnicity, age at enrollment, time to diagnosis, ADI, JIA category, presence of secondary rheumatologic disease, and medication (use of a conventional synthetic disease-modifying antirheumatic drug [DMARD], biologic DMARD, or small molecule drug).
Nearly half (48%) of patients had active disease during follow-up, with an average clinical JADAS score of 4 from the whole cohort. Compared with children with a cumulative disadvantage score of 0, each additional point on the clinical JADAS resulted in significantly increased odds of active disease. Those with the highest score of 3 were twice as likely to have active disease (adjusted odds ratio [aOR], 2.05; P < .001) as those with a score of 0, but those with a score of 1 (aOR, 1.36; P < .001) or 2 (aOR, 1.86; P < .001) were also more likely to have active disease. Other significant independent predictors of active arthritis included being of Black race (aOR, 1.55) or more than one race (aOR, 1.31).
Each of the scored factors also independently increased the likelihood of active disease by similar amounts: 1.69 higher odds for low household income on its own, 1.6 higher odds for public or no insurance, and 1.45 higher odds for high school education or less (all P < .001).
Similarly, odds of functional disability based on CHAQ increased significantly with each additional point. The mean CHAQ score was 0.31, and 46% of patients had functional disability during follow-up. Those with a cumulative social disadvantage score of 3 were three times as likely to have functional disability (aOR, 3.09; P < .001) as those with a score of 0. Those with a score of 1 (aOR, 1.82) or 2 (aOR, 2.81) were also more likely to have functional disability (P < .001). Again, Black individuals (aOR, 2.09) or those of mixed race (aOR, 1.78) had greater odds of functional disability (P < .001).
The independent factor most associated with increased odds of functional disability was a household income below $50,000 a year (OR, 3.03; P < .001), followed by having public or no insurance (OR, 2.57) or a caregiver with no more than a high school education (OR, 1.98). Dr. Soulsby noted that their study was limited by the missing data and may oversimplify the relationships between social determinants of health.
Overall, however, the findings revealed both the importance of social risk screening in the pediatric rheumatology clinic and the coupling of that screening with individual level support for patients, Dr. Soulsby said.
“This study did a great job of harnessing the power of the CARRA Registry,” said Dr. Ardoin, who was not involved in the research. “These findings underscore how important it is for all clinicians, including pediatric rheumatologists, to evaluate every child for social risks of poor outcomes,” she said.
One take-home message from the findings is that once pediatric rheumatologists identify social risks for poor outcomes in their patients, they can “consult with social workers and connect families with community resources in an effort to ameliorate social deprivation.”
Childhood Lupus and Reduced Childhood Opportunity
In a similar study looking at children with childhood-onset lupus, researchers similarly identified the way that compounding social determinants of health were linked to greater disease activity.
“We know that structural racism segregates children from historically marginalized groups into different neighborhoods with lower childhood opportunity,” Joyce C. Chang, MD, of Boston Children’s Hospital, told attendees. “When we talk about child opportunity, we’re really describing all of the resources and conditions that helped to promote healthy childhood development,” including factors related to education, physical health, the built environment, and social and economic security, she said.
Dr. Chang and her colleagues therefore assessed the relationship between a 29-indicator Child Opportunity Index for patients with childhood-onset lupus and the severity of their disease presentation and activity over time. They determined the Child Opportunity Index for different neighborhoods and assessed the amount of racial residential segregation around the three institutions involved in the study. Severity of lupus presentation was based on the need for intensive care unit admission or dialysis or a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 10 or higher. Disease activity over time was based on the SLEDAI-2K score.
The patient population included 553 patients with childhood-onset lupus from three institutions: Boston Children’s Hospital, Lurie Children’s Hospital of Chicago, and Children’s of Alabama in Birmingham, Alabama. Across the full population, 30% of the patients were Black and 30% were Hispanic, but the distribution of race and ethnicity varied by institution. Most of the Black patients, for example, were at Children’s of Alabama (59%), while 43% of the Hispanic patients were at Lurie. Across all the sites, 14% of the patients’ families preferred a non-English language as their first language, and just over half the patients (52%) had public insurance.
Dr. Chang did not have data yet from the Lurie and Alabama cohorts, so she presented preliminary data from the Boston Children’s cohort of 148 patients. In those results, children living in neighborhoods of low childhood opportunity had four times higher odds of presenting with severe disease than children living in neighborhoods of very high opportunity. Then the researchers factored in the location quotient that represented the magnitude of racial segregation in a residential area. In areas with high levels of Black vs White segregation, children were 2.5 times more likely to have a more severe initial disease presentation. However, there was not a significant difference in areas highly segregated between Hispanic and non-Hispanic residents.
After initial presentation, the data revealed a dose-dependent relationship between childhood opportunity and severity of disease activity based on SLEDAI-2K. After adjustment for insurance status, race, preferred language, age at disease onset, sex, major organ involvement, initial SLEDAI-2K score at presentation, and follow-up time, disease activity incrementally increased as childhood opportunity decreased (P < .001 for the trend).
The findings suggested that even in regions like Boston, where overall childhood opportunity is higher than the national average, “poor relative neighborhood opportunity is still associated with more severe lupus presentation, as well as higher lupus disease activity during follow-up,” Dr. Chang said. “Area-level conditions may drive inequitable outcomes at numerous points,” including initial access to subspecialty care and after establishing that care, she said.
Dr. Soulsby, Dr. Chang, and Dr. Ardoin reported having no disclosures. Dr. Soulsby’s research was funded by CARRA and the Arthritis Foundation, and Dr. Chang’s research was funded by CARRA.
A version of this article appeared on Medscape.com.
The accumulation of multiple adverse social determinants of health is linked to worse disease at initial presentation and worse disease activity over time in children with rheumatologic conditions, according to findings presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance.
One study revealed that cumulative factors conferring social disadvantage progressively increased the odds of active disease and functional disability in children with juvenile idiopathic arthritis (JIA). Another study similarly found that children with lupus living in neighborhoods with comparatively fewer resources for childhood opportunity had worse disease at presentation and greater disease activity over follow-up.
, William Daniel Soulsby, MD, of the University of California San Francisco, told attendees in his presentation of data from the JIA study.
“Most prior studies have analyzed such determinants as independent risk factors,” Dr. Soulsby said. “However, individuals experiencing social disadvantage often face multiple social hardships that rarely act in isolation; studying these factors independently may miss underlying disparities.”
Stacy P. Ardoin, MD, MSc, professor of pediatric and adult rheumatology at Nationwide Children’s Hospital and The Ohio State University in Columbus, and vice president of CARRA, did not find the results of Soulsby’s study surprising, but she said they do “provide important confirmation of our growing understanding of the impact of social determinants of health on the outcomes of children and adolescents with chronic disease like juvenile idiopathic arthritis.” She added: “In medicine, we often think about the bench, the bedside, and the clinic, but this study tells us that if we want to improve outcomes for our patients, we also need to think about the ‘backyard,’ too.”
Social Disadvantage With JIA
Dr. Soulsby’s team adopted an approach similar to that of a recent National Survey of Children’s Health analysis that used a combined scoring system to calculate cumulative social disadvantage. The researchers used income level, insurance status, and education level to capture individual factors related to disadvantage and then an area deprivation index (ADI) to capture community factors. While they were unable to use any variables specific to societal factors, they included race, which is relevant at all three levels.
The cohort included 9612 patients in the CARRA Registry from July 2015 to January 2022. They included all patients who had a JIA diagnosis with onset before age 16 and at least one visit with a complete clinical Juvenile Arthritis Disease Activity Score (JADAS) score. Most of the patients (70%) were female, with an average age at enrollment of 11 and a mean time to diagnosis of 10.6 months.
Most of the patients had oligoarthritis (35.5%) or rheumatoid factor–negative polyarthritis (29.4%), followed by enthesitis-related arthritis (10.5%) and then other forms. A total of 4% of patients had a secondary rheumatologic condition. Most of the patients were White (74.9%), with 3.9% Black, 7.6% Hispanic, and 6.5% of more than one race. ADI data were missing for 17.2% of patients.
The researchers assigned a score to each patient that could add up to a maximum of 3. They received 1 point for an annual household income below $50,000, 1 point for having public insurance or no insurance, and 1 point for their guardian having no more than a high school education. Patients with a score of 0 comprised 60.9% of the patients, while 21.3% had a score of 1, 12.9% had a score of 2, and 4.9% had a score of 3.
Just over a quarter of the patients (26.3%) were underinsured, 19.1% were low income, and 16.4% had caregivers with a high school education or less. However, income level was unknown for 24.6% of patients, and guardians’ education level was unknown for 15.7% of patients.
The primary outcomes were the odds of active disease as based on clinical JADAS (at least a 1.1 score for oligoarticular JIA and more than 2.5 for all other subtypes) and odds of functional disability based on the Childhood Health Assessment Questionnaire (CHAQ). Adjustments were made for sex, race/ethnicity, age at enrollment, time to diagnosis, ADI, JIA category, presence of secondary rheumatologic disease, and medication (use of a conventional synthetic disease-modifying antirheumatic drug [DMARD], biologic DMARD, or small molecule drug).
Nearly half (48%) of patients had active disease during follow-up, with an average clinical JADAS score of 4 from the whole cohort. Compared with children with a cumulative disadvantage score of 0, each additional point on the clinical JADAS resulted in significantly increased odds of active disease. Those with the highest score of 3 were twice as likely to have active disease (adjusted odds ratio [aOR], 2.05; P < .001) as those with a score of 0, but those with a score of 1 (aOR, 1.36; P < .001) or 2 (aOR, 1.86; P < .001) were also more likely to have active disease. Other significant independent predictors of active arthritis included being of Black race (aOR, 1.55) or more than one race (aOR, 1.31).
Each of the scored factors also independently increased the likelihood of active disease by similar amounts: 1.69 higher odds for low household income on its own, 1.6 higher odds for public or no insurance, and 1.45 higher odds for high school education or less (all P < .001).
Similarly, odds of functional disability based on CHAQ increased significantly with each additional point. The mean CHAQ score was 0.31, and 46% of patients had functional disability during follow-up. Those with a cumulative social disadvantage score of 3 were three times as likely to have functional disability (aOR, 3.09; P < .001) as those with a score of 0. Those with a score of 1 (aOR, 1.82) or 2 (aOR, 2.81) were also more likely to have functional disability (P < .001). Again, Black individuals (aOR, 2.09) or those of mixed race (aOR, 1.78) had greater odds of functional disability (P < .001).
The independent factor most associated with increased odds of functional disability was a household income below $50,000 a year (OR, 3.03; P < .001), followed by having public or no insurance (OR, 2.57) or a caregiver with no more than a high school education (OR, 1.98). Dr. Soulsby noted that their study was limited by the missing data and may oversimplify the relationships between social determinants of health.
Overall, however, the findings revealed both the importance of social risk screening in the pediatric rheumatology clinic and the coupling of that screening with individual level support for patients, Dr. Soulsby said.
“This study did a great job of harnessing the power of the CARRA Registry,” said Dr. Ardoin, who was not involved in the research. “These findings underscore how important it is for all clinicians, including pediatric rheumatologists, to evaluate every child for social risks of poor outcomes,” she said.
One take-home message from the findings is that once pediatric rheumatologists identify social risks for poor outcomes in their patients, they can “consult with social workers and connect families with community resources in an effort to ameliorate social deprivation.”
Childhood Lupus and Reduced Childhood Opportunity
In a similar study looking at children with childhood-onset lupus, researchers similarly identified the way that compounding social determinants of health were linked to greater disease activity.
“We know that structural racism segregates children from historically marginalized groups into different neighborhoods with lower childhood opportunity,” Joyce C. Chang, MD, of Boston Children’s Hospital, told attendees. “When we talk about child opportunity, we’re really describing all of the resources and conditions that helped to promote healthy childhood development,” including factors related to education, physical health, the built environment, and social and economic security, she said.
Dr. Chang and her colleagues therefore assessed the relationship between a 29-indicator Child Opportunity Index for patients with childhood-onset lupus and the severity of their disease presentation and activity over time. They determined the Child Opportunity Index for different neighborhoods and assessed the amount of racial residential segregation around the three institutions involved in the study. Severity of lupus presentation was based on the need for intensive care unit admission or dialysis or a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 10 or higher. Disease activity over time was based on the SLEDAI-2K score.
The patient population included 553 patients with childhood-onset lupus from three institutions: Boston Children’s Hospital, Lurie Children’s Hospital of Chicago, and Children’s of Alabama in Birmingham, Alabama. Across the full population, 30% of the patients were Black and 30% were Hispanic, but the distribution of race and ethnicity varied by institution. Most of the Black patients, for example, were at Children’s of Alabama (59%), while 43% of the Hispanic patients were at Lurie. Across all the sites, 14% of the patients’ families preferred a non-English language as their first language, and just over half the patients (52%) had public insurance.
Dr. Chang did not have data yet from the Lurie and Alabama cohorts, so she presented preliminary data from the Boston Children’s cohort of 148 patients. In those results, children living in neighborhoods of low childhood opportunity had four times higher odds of presenting with severe disease than children living in neighborhoods of very high opportunity. Then the researchers factored in the location quotient that represented the magnitude of racial segregation in a residential area. In areas with high levels of Black vs White segregation, children were 2.5 times more likely to have a more severe initial disease presentation. However, there was not a significant difference in areas highly segregated between Hispanic and non-Hispanic residents.
After initial presentation, the data revealed a dose-dependent relationship between childhood opportunity and severity of disease activity based on SLEDAI-2K. After adjustment for insurance status, race, preferred language, age at disease onset, sex, major organ involvement, initial SLEDAI-2K score at presentation, and follow-up time, disease activity incrementally increased as childhood opportunity decreased (P < .001 for the trend).
The findings suggested that even in regions like Boston, where overall childhood opportunity is higher than the national average, “poor relative neighborhood opportunity is still associated with more severe lupus presentation, as well as higher lupus disease activity during follow-up,” Dr. Chang said. “Area-level conditions may drive inequitable outcomes at numerous points,” including initial access to subspecialty care and after establishing that care, she said.
Dr. Soulsby, Dr. Chang, and Dr. Ardoin reported having no disclosures. Dr. Soulsby’s research was funded by CARRA and the Arthritis Foundation, and Dr. Chang’s research was funded by CARRA.
A version of this article appeared on Medscape.com.
FROM CARRA 2024
Treating Active Psoriatic Arthritis When the First-Line Biologic Fails
Over the past two decades, the therapeutic landscape for psoriatic arthritis (PsA) has been transformed by the introduction of more than a dozen targeted therapies.
For most patients with active PsA, a tumor necrosis factor (TNF) inhibitor is recommended as the first-line biologic therapy. But some patients do not achieve an adequate response to TNF inhibitors or are intolerant to these therapies.
Choosing the right treatment after failure of the first biologic requires that clinicians consider several factors. Dr Atul Deodhar, of Oregon Health & Science University, discusses guidelines from the American College of Rheumatology/National Psoriasis Foundation and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) for appropriate treatment strategies.
He also discusses factors critical to the optimal choice of the next therapy, such as the domains of disease activity, patient comorbidities, and whether the biologic's failure was primary or secondary.
Aside from choosing a new biologic, Dr Deodhar notes that there are other options to intensify the effect of the initial biologic. He says the clinician and patient may consider increasing the dose and frequency of the initial biologic medication or moving to a combination therapy by adding another drug, such as methotrexate.
--
Atul A. Deodhar, MD, Professor of Medicine, Division of Arthritis and Rheumatic Diseases, School of Medicine, Oregon Health & Science University; Medical Director, Rheumatology Clinics, OHSU Hospital, Portland, Oregon
Atul A. Deodhar, MD, has disclosed the following relevant financial relationships:
Serve(d) as a consultant, for: Bristol Myers Squibb; Eli Lilly; Janssen; MoonLake; Novartis; Pfizer; UCB
Serve(d) as a speaker for: Eli Lilly; Novartis; Pfizer; UCB
Received research grant from: AbbVie; Bristol Myers Squibb; Celgene; Janssen; MoonLake; Novartis; Pfizer; UCB
Received income in an amount equal to or greater than $250 from: Bristol Myers Squibb; Eli Lilly; Janssen; Novartis; Pfizer; Samsung Bioepis; UCB
Over the past two decades, the therapeutic landscape for psoriatic arthritis (PsA) has been transformed by the introduction of more than a dozen targeted therapies.
For most patients with active PsA, a tumor necrosis factor (TNF) inhibitor is recommended as the first-line biologic therapy. But some patients do not achieve an adequate response to TNF inhibitors or are intolerant to these therapies.
Choosing the right treatment after failure of the first biologic requires that clinicians consider several factors. Dr Atul Deodhar, of Oregon Health & Science University, discusses guidelines from the American College of Rheumatology/National Psoriasis Foundation and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) for appropriate treatment strategies.
He also discusses factors critical to the optimal choice of the next therapy, such as the domains of disease activity, patient comorbidities, and whether the biologic's failure was primary or secondary.
Aside from choosing a new biologic, Dr Deodhar notes that there are other options to intensify the effect of the initial biologic. He says the clinician and patient may consider increasing the dose and frequency of the initial biologic medication or moving to a combination therapy by adding another drug, such as methotrexate.
--
Atul A. Deodhar, MD, Professor of Medicine, Division of Arthritis and Rheumatic Diseases, School of Medicine, Oregon Health & Science University; Medical Director, Rheumatology Clinics, OHSU Hospital, Portland, Oregon
Atul A. Deodhar, MD, has disclosed the following relevant financial relationships:
Serve(d) as a consultant, for: Bristol Myers Squibb; Eli Lilly; Janssen; MoonLake; Novartis; Pfizer; UCB
Serve(d) as a speaker for: Eli Lilly; Novartis; Pfizer; UCB
Received research grant from: AbbVie; Bristol Myers Squibb; Celgene; Janssen; MoonLake; Novartis; Pfizer; UCB
Received income in an amount equal to or greater than $250 from: Bristol Myers Squibb; Eli Lilly; Janssen; Novartis; Pfizer; Samsung Bioepis; UCB
Over the past two decades, the therapeutic landscape for psoriatic arthritis (PsA) has been transformed by the introduction of more than a dozen targeted therapies.
For most patients with active PsA, a tumor necrosis factor (TNF) inhibitor is recommended as the first-line biologic therapy. But some patients do not achieve an adequate response to TNF inhibitors or are intolerant to these therapies.
Choosing the right treatment after failure of the first biologic requires that clinicians consider several factors. Dr Atul Deodhar, of Oregon Health & Science University, discusses guidelines from the American College of Rheumatology/National Psoriasis Foundation and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) for appropriate treatment strategies.
He also discusses factors critical to the optimal choice of the next therapy, such as the domains of disease activity, patient comorbidities, and whether the biologic's failure was primary or secondary.
Aside from choosing a new biologic, Dr Deodhar notes that there are other options to intensify the effect of the initial biologic. He says the clinician and patient may consider increasing the dose and frequency of the initial biologic medication or moving to a combination therapy by adding another drug, such as methotrexate.
--
Atul A. Deodhar, MD, Professor of Medicine, Division of Arthritis and Rheumatic Diseases, School of Medicine, Oregon Health & Science University; Medical Director, Rheumatology Clinics, OHSU Hospital, Portland, Oregon
Atul A. Deodhar, MD, has disclosed the following relevant financial relationships:
Serve(d) as a consultant, for: Bristol Myers Squibb; Eli Lilly; Janssen; MoonLake; Novartis; Pfizer; UCB
Serve(d) as a speaker for: Eli Lilly; Novartis; Pfizer; UCB
Received research grant from: AbbVie; Bristol Myers Squibb; Celgene; Janssen; MoonLake; Novartis; Pfizer; UCB
Received income in an amount equal to or greater than $250 from: Bristol Myers Squibb; Eli Lilly; Janssen; Novartis; Pfizer; Samsung Bioepis; UCB
Approval of Spesolimab for Generalized Pustular Psoriasis Expanded
The in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer.
This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.
According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo.
Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.
A version of this article appeared on Medscape.com.
The in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer.
This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.
According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo.
Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.
A version of this article appeared on Medscape.com.
The in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer.
This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.
According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo.
Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.
A version of this article appeared on Medscape.com.
LITE Study Provides Encouraging Data on Home-Based Phototherapy for Psoriasis
SAN DIEGO — and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.
“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 
“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”
Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
LITE Study Data
In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a DLQI score of 5 or less (small, no effect on health-related quality of life).
Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.
The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks.
At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
An Improvement in Health Equity
Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).
In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.
Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.
“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”
The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.
“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”
LITE Study Described as “Groundbreaking”
One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”
Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”
This is important, he continued, “because it can inform payers to approve home phototherapy equipment for patients, because it’s much more convenient and it definitely works. The other strong point of the study is that it included patients of different skin types,” he said in an interview at the meeting.
The study was funded by the Patient-Centered Outcomes Research Institute. Research partners included the National Psoriasis Foundation and Daavlin, which provided the home phototherapy machines and covered the cost of shipping the devices. Dr. Gelfand reported no relevant financial relationships. Dr. Blauvelt disclosed conflicts of interest from many pharmaceutical companies. Dr. Lim disclosed conflicts of interest from many pharmaceutical companies.
A version of this article appeared on Medscape.com.
SAN DIEGO — and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.
“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.
“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”
Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
LITE Study Data
In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a DLQI score of 5 or less (small, no effect on health-related quality of life).
Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.
The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks.
At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
An Improvement in Health Equity
Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).
In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.
Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.
“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”
The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.
“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”
LITE Study Described as “Groundbreaking”
One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”
Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”
This is important, he continued, “because it can inform payers to approve home phototherapy equipment for patients, because it’s much more convenient and it definitely works. The other strong point of the study is that it included patients of different skin types,” he said in an interview at the meeting.
The study was funded by the Patient-Centered Outcomes Research Institute. Research partners included the National Psoriasis Foundation and Daavlin, which provided the home phototherapy machines and covered the cost of shipping the devices. Dr. Gelfand reported no relevant financial relationships. Dr. Blauvelt disclosed conflicts of interest from many pharmaceutical companies. Dr. Lim disclosed conflicts of interest from many pharmaceutical companies.
A version of this article appeared on Medscape.com.
SAN DIEGO — and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.
“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology.
“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”
Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
LITE Study Data
In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a DLQI score of 5 or less (small, no effect on health-related quality of life).
Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.
The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks.
At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
An Improvement in Health Equity
Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).
In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.
Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.
“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”
The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.
“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”
LITE Study Described as “Groundbreaking”
One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”
Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”
This is important, he continued, “because it can inform payers to approve home phototherapy equipment for patients, because it’s much more convenient and it definitely works. The other strong point of the study is that it included patients of different skin types,” he said in an interview at the meeting.
The study was funded by the Patient-Centered Outcomes Research Institute. Research partners included the National Psoriasis Foundation and Daavlin, which provided the home phototherapy machines and covered the cost of shipping the devices. Dr. Gelfand reported no relevant financial relationships. Dr. Blauvelt disclosed conflicts of interest from many pharmaceutical companies. Dr. Lim disclosed conflicts of interest from many pharmaceutical companies.
A version of this article appeared on Medscape.com.
FROM AAD 2024
Early Diagnosis Improves Clinical Outcomes in Psoriatic Arthritis
TOPLINE:
An earlier diagnosis of psoriatic arthritis (PsA) following symptom onset increases the likelihood of achieving improved clinical outcomes, highlighting the presence of a diagnostic window of opportunity in PsA.
METHODOLOGY:
- A diagnostic delay in PsA leads to increased joint erosions and functional impairment; however, whether a “window of opportunity” (< 12 weeks) exists in PsA requires further evaluation.
- Researchers assessed the impact of diagnostic delay on clinical outcomes in 708 newly diagnosed, disease-modifying antirheumatic drug-naive patients with PsA from the Dutch southwest Early PsA cohort.
- Total diagnostic delay was calculated as the time period between symptom onset and PsA diagnosis made by a rheumatologist.
- On the basis of the total diagnostic delay, patients were categorized into those with a short delay of < 12 weeks (n = 136), intermediate delay of 12 weeks to 1 year (n = 237), and a long delay of > 1 year (n = 335).
- The groups were compared for clinical (Minimal Disease Activity [MDA] and Disease Activity index for Psoriatic Arthritis [DAPSA] remission) and patient-reported outcomes during 3 years of follow-up.
TAKEAWAY:
- The probability of achieving MDA was higher in patients with a short vs long diagnostic delay (odds ratio [OR], 2.55; 95% CI, 1.37-4.76).
- Compared with patients in the long diagnostic delay group, those in the short (OR, 2.35; 95% CI, 1.32-4.19) and intermediate (OR, 1.94; 95% CI, 1.19-3.15) diagnostic delay groups were more likely to achieve DAPSA remission.
- Compared with patients in the long diagnostic delay group, those in the short (estimated mean difference [Δ], −1.09; 95% CI, −1.88 to −0.30) or intermediate (Δ, −0.85; 95% CI, −1.50 to −0.19) groups had slightly less tender joints.
IN PRACTICE:
“A delay of > 1 year is associated with worse clinical outcomes, which includes almost 50% of the PsA population” in this study, wrote the authors, adding that for better long-term outcomes, “it is important that PsA patients are diagnosed by a rheumatologist within 1 year after symptom onset.”
SOURCE:
This study, led by Selinde V.J. Snoeck Henkemans, MD, of the department of rheumatology at Erasmus University Medical Center, Rotterdam, the Netherlands, was published online February 27, 2024, in RMD Open.
LIMITATIONS:
The study’s dropout rates (25%-31% across groups) may have influenced the findings. Patients with a long diagnostic delay might have dropped out owing to treatment dissatisfaction, and those with a short or intermediate delay might have dropped out due to inactive disease.
DISCLOSURES:
This study did not declare any specific source of funding. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
An earlier diagnosis of psoriatic arthritis (PsA) following symptom onset increases the likelihood of achieving improved clinical outcomes, highlighting the presence of a diagnostic window of opportunity in PsA.
METHODOLOGY:
- A diagnostic delay in PsA leads to increased joint erosions and functional impairment; however, whether a “window of opportunity” (< 12 weeks) exists in PsA requires further evaluation.
- Researchers assessed the impact of diagnostic delay on clinical outcomes in 708 newly diagnosed, disease-modifying antirheumatic drug-naive patients with PsA from the Dutch southwest Early PsA cohort.
- Total diagnostic delay was calculated as the time period between symptom onset and PsA diagnosis made by a rheumatologist.
- On the basis of the total diagnostic delay, patients were categorized into those with a short delay of < 12 weeks (n = 136), intermediate delay of 12 weeks to 1 year (n = 237), and a long delay of > 1 year (n = 335).
- The groups were compared for clinical (Minimal Disease Activity [MDA] and Disease Activity index for Psoriatic Arthritis [DAPSA] remission) and patient-reported outcomes during 3 years of follow-up.
TAKEAWAY:
- The probability of achieving MDA was higher in patients with a short vs long diagnostic delay (odds ratio [OR], 2.55; 95% CI, 1.37-4.76).
- Compared with patients in the long diagnostic delay group, those in the short (OR, 2.35; 95% CI, 1.32-4.19) and intermediate (OR, 1.94; 95% CI, 1.19-3.15) diagnostic delay groups were more likely to achieve DAPSA remission.
- Compared with patients in the long diagnostic delay group, those in the short (estimated mean difference [Δ], −1.09; 95% CI, −1.88 to −0.30) or intermediate (Δ, −0.85; 95% CI, −1.50 to −0.19) groups had slightly less tender joints.
IN PRACTICE:
“A delay of > 1 year is associated with worse clinical outcomes, which includes almost 50% of the PsA population” in this study, wrote the authors, adding that for better long-term outcomes, “it is important that PsA patients are diagnosed by a rheumatologist within 1 year after symptom onset.”
SOURCE:
This study, led by Selinde V.J. Snoeck Henkemans, MD, of the department of rheumatology at Erasmus University Medical Center, Rotterdam, the Netherlands, was published online February 27, 2024, in RMD Open.
LIMITATIONS:
The study’s dropout rates (25%-31% across groups) may have influenced the findings. Patients with a long diagnostic delay might have dropped out owing to treatment dissatisfaction, and those with a short or intermediate delay might have dropped out due to inactive disease.
DISCLOSURES:
This study did not declare any specific source of funding. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
An earlier diagnosis of psoriatic arthritis (PsA) following symptom onset increases the likelihood of achieving improved clinical outcomes, highlighting the presence of a diagnostic window of opportunity in PsA.
METHODOLOGY:
- A diagnostic delay in PsA leads to increased joint erosions and functional impairment; however, whether a “window of opportunity” (< 12 weeks) exists in PsA requires further evaluation.
- Researchers assessed the impact of diagnostic delay on clinical outcomes in 708 newly diagnosed, disease-modifying antirheumatic drug-naive patients with PsA from the Dutch southwest Early PsA cohort.
- Total diagnostic delay was calculated as the time period between symptom onset and PsA diagnosis made by a rheumatologist.
- On the basis of the total diagnostic delay, patients were categorized into those with a short delay of < 12 weeks (n = 136), intermediate delay of 12 weeks to 1 year (n = 237), and a long delay of > 1 year (n = 335).
- The groups were compared for clinical (Minimal Disease Activity [MDA] and Disease Activity index for Psoriatic Arthritis [DAPSA] remission) and patient-reported outcomes during 3 years of follow-up.
TAKEAWAY:
- The probability of achieving MDA was higher in patients with a short vs long diagnostic delay (odds ratio [OR], 2.55; 95% CI, 1.37-4.76).
- Compared with patients in the long diagnostic delay group, those in the short (OR, 2.35; 95% CI, 1.32-4.19) and intermediate (OR, 1.94; 95% CI, 1.19-3.15) diagnostic delay groups were more likely to achieve DAPSA remission.
- Compared with patients in the long diagnostic delay group, those in the short (estimated mean difference [Δ], −1.09; 95% CI, −1.88 to −0.30) or intermediate (Δ, −0.85; 95% CI, −1.50 to −0.19) groups had slightly less tender joints.
IN PRACTICE:
“A delay of > 1 year is associated with worse clinical outcomes, which includes almost 50% of the PsA population” in this study, wrote the authors, adding that for better long-term outcomes, “it is important that PsA patients are diagnosed by a rheumatologist within 1 year after symptom onset.”
SOURCE:
This study, led by Selinde V.J. Snoeck Henkemans, MD, of the department of rheumatology at Erasmus University Medical Center, Rotterdam, the Netherlands, was published online February 27, 2024, in RMD Open.
LIMITATIONS:
The study’s dropout rates (25%-31% across groups) may have influenced the findings. Patients with a long diagnostic delay might have dropped out owing to treatment dissatisfaction, and those with a short or intermediate delay might have dropped out due to inactive disease.
DISCLOSURES:
This study did not declare any specific source of funding. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
Sustained Control Reported for Anti–IL-17, Anti–IL-23 Psoriasis Treatments
SAN DIEGO — , but late-breaker data presented at the annual meeting of the American Academy of Dermatology show that these types of responses are sustained for as long as patients have remained on therapy.
Of the two, the longer follow up is with the IL-17 inhibitor bimekizumab (Bimzelx). In a 4-year open-label extension study, the Psoriasis Area and Severity Index (PASI) 90 rate was approximately 85% in treated patients, according to Mark Lebwohl, MD, professor and chairman emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York City
A PASI 90 score signifies that 90% of skin surface area is cleared. The proportion of patients who achieved a PASI 100 score, signifying total clearance, approached 70% at 4 years in the group with the greatest response. PASI 90 and PASI 100 rates at this point were only modestly lower than those reported at the end of the double-blind phase 3 trial when evaluated 3 years earlier.
Follow-up with a novel oral anti-IL-23 inhibitor JNJ-2113 (JNJ-77242113) was only 52 weeks, far shorter. But again, the response for the most effective dose at the end of this period was essentially unchanged from that at 16 weeks. Among those on the highest and most effective test dose of once-daily 100 mg, the PASI 90 at 1 year was 64.3%, a rate that was essentially unchanged from week 16.
No Apparent Loss of Benefit Over Time
“We can really look at those dose-response curves and see that there is, overall, a maintenance of response,” reported Laura K. Ferris, MD, PhD, professor and director of clinical trials, Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. In her presentation of the data, she showed similar sustained control for the most effective doses of JNJ-2113 for multiple clinical outcomes, including an investigator’s global assessment (IGA) score of 0 or 1, also signifying clear or near clear skin.
Bimekizumab, a monoclonal antibody that inhibits both IL-17A and IL-17F, is already approved for the treatment of plaque psoriasis. The 52-week BE SURE trial, which provided the 478 patients who entered into the BE BRIGHT open label extension study, was published in The New England Journal of Medicine in July 2021.
In the 4-year data reported by Dr. Lebwohl, three groups were compared: Those initially randomized to an every-4-week dosing schedule of bimekizumab over the course of the 52-week BE SURE trial; those randomized to an every-4-week bimekizumab schedule who were then subsequently switched to an every-8-week schedule; and those initiated on the TNF-inhibitor adalimumab (Humira) and were then switched at week 24 to every-4-week bimekizumab.
The PASI 90 responses at 52 weeks in these three groups, respectively, were 91.2%, 89.3%, and 95.2%. At 4 years, this almost clear response was observed in 82.4%, 83.2%, and 87.6%, respectively. At 52 weeks, the PASI 100 responses in these three groups, respectively, were 75.3%, 74.2%, and 72.9%. At 4 years, 61.9%, 58.5%, and 69.5% still had complete skin clearance.
Bimekizumab was well tolerated during the randomized trial, reported Dr. Lebwohl. The rates of nasopharyngitis and oral candidiasis, which were observed in approximately 12% and 8%, respectively, of treated patients during the randomized phase remained at about the same level in the long-term follow up. There were no new safety signals, he said.
JNJ-2113 Is First Potential Oral IL-23 Inhibitor
JNJ-2113 is a first-in-class oral peptide that binds to the IL-23 receptor, blocking the IL-23 signaling pathway. If approved, it would be the first oral therapy targeting IL-23. The 16-week outcomes of the dose-finding FRONTIER 1 phase 2b trial were published in The New England Journal of Medicine earlier this year. The primary endpoint was PASI 75, achieved by 79% of those on the 100 mg twice daily dose at week 16, vs 9% on placebo, and at 52 weeks, was 76%.
“The proportion of patients achieving the FRONTIER 1 primary endpoint was maintained from week 16 to the end of week 52 in the extension study,” Dr. Ferris said, but further pointed out that rates of near or complete clearance achieved at week 16 were also essentially unchanged at week 52. This was true of PASI scores and IGA.
Clearance of psoriatic lesions on the scalp was particularly impressive. By scalp-specific IGA, rates of clear or near clear (0/1) were not just maintained but improved over the course of follow-up, reaching 75.1% at 52 weeks in the highest dose group, she said.
JNJ-2113 was well tolerated in FRONTIER 1 and remained so during long-term follow-up, in the FRONTIER 2 extension study, according to Dr. Ferris. The most common complaints with JNJ-2113, such as nasopharyngitis (18.1% vs 25.7% in placebo), did not appear to differ significantly from placebo and the treatment remained well tolerated over the course of the extended follow-up.
There are limited direct comparisons of different biologics active in the treatment of plaque psoriasis for efficacy and safety, but these data appear to show a depth and durability of benefit for psoriasis that is exceptional, Dr. Lebwohl told this news organization. “The PASI 100 scores achieved by bimekizumab exceed anything we have seen to date,” he said. “And the durability of those exceedingly high scores is remarkable.”
Dr. Lebwohl reports financial relationships with approximately 40 pharmaceutical companies, including UCB Pharma, which developed bimekizumab. Dr. Ferris reports financial relationships with more than 20 pharmaceutical companies, including Janssen, which is developing JNJ-2113.
A version of this article appeared on Medscape.com.
SAN DIEGO — , but late-breaker data presented at the annual meeting of the American Academy of Dermatology show that these types of responses are sustained for as long as patients have remained on therapy.
Of the two, the longer follow up is with the IL-17 inhibitor bimekizumab (Bimzelx). In a 4-year open-label extension study, the Psoriasis Area and Severity Index (PASI) 90 rate was approximately 85% in treated patients, according to Mark Lebwohl, MD, professor and chairman emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York City
A PASI 90 score signifies that 90% of skin surface area is cleared. The proportion of patients who achieved a PASI 100 score, signifying total clearance, approached 70% at 4 years in the group with the greatest response. PASI 90 and PASI 100 rates at this point were only modestly lower than those reported at the end of the double-blind phase 3 trial when evaluated 3 years earlier.
Follow-up with a novel oral anti-IL-23 inhibitor JNJ-2113 (JNJ-77242113) was only 52 weeks, far shorter. But again, the response for the most effective dose at the end of this period was essentially unchanged from that at 16 weeks. Among those on the highest and most effective test dose of once-daily 100 mg, the PASI 90 at 1 year was 64.3%, a rate that was essentially unchanged from week 16.
No Apparent Loss of Benefit Over Time
“We can really look at those dose-response curves and see that there is, overall, a maintenance of response,” reported Laura K. Ferris, MD, PhD, professor and director of clinical trials, Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. In her presentation of the data, she showed similar sustained control for the most effective doses of JNJ-2113 for multiple clinical outcomes, including an investigator’s global assessment (IGA) score of 0 or 1, also signifying clear or near clear skin.
Bimekizumab, a monoclonal antibody that inhibits both IL-17A and IL-17F, is already approved for the treatment of plaque psoriasis. The 52-week BE SURE trial, which provided the 478 patients who entered into the BE BRIGHT open label extension study, was published in The New England Journal of Medicine in July 2021.
In the 4-year data reported by Dr. Lebwohl, three groups were compared: Those initially randomized to an every-4-week dosing schedule of bimekizumab over the course of the 52-week BE SURE trial; those randomized to an every-4-week bimekizumab schedule who were then subsequently switched to an every-8-week schedule; and those initiated on the TNF-inhibitor adalimumab (Humira) and were then switched at week 24 to every-4-week bimekizumab.
The PASI 90 responses at 52 weeks in these three groups, respectively, were 91.2%, 89.3%, and 95.2%. At 4 years, this almost clear response was observed in 82.4%, 83.2%, and 87.6%, respectively. At 52 weeks, the PASI 100 responses in these three groups, respectively, were 75.3%, 74.2%, and 72.9%. At 4 years, 61.9%, 58.5%, and 69.5% still had complete skin clearance.
Bimekizumab was well tolerated during the randomized trial, reported Dr. Lebwohl. The rates of nasopharyngitis and oral candidiasis, which were observed in approximately 12% and 8%, respectively, of treated patients during the randomized phase remained at about the same level in the long-term follow up. There were no new safety signals, he said.
JNJ-2113 Is First Potential Oral IL-23 Inhibitor
JNJ-2113 is a first-in-class oral peptide that binds to the IL-23 receptor, blocking the IL-23 signaling pathway. If approved, it would be the first oral therapy targeting IL-23. The 16-week outcomes of the dose-finding FRONTIER 1 phase 2b trial were published in The New England Journal of Medicine earlier this year. The primary endpoint was PASI 75, achieved by 79% of those on the 100 mg twice daily dose at week 16, vs 9% on placebo, and at 52 weeks, was 76%.
“The proportion of patients achieving the FRONTIER 1 primary endpoint was maintained from week 16 to the end of week 52 in the extension study,” Dr. Ferris said, but further pointed out that rates of near or complete clearance achieved at week 16 were also essentially unchanged at week 52. This was true of PASI scores and IGA.
Clearance of psoriatic lesions on the scalp was particularly impressive. By scalp-specific IGA, rates of clear or near clear (0/1) were not just maintained but improved over the course of follow-up, reaching 75.1% at 52 weeks in the highest dose group, she said.
JNJ-2113 was well tolerated in FRONTIER 1 and remained so during long-term follow-up, in the FRONTIER 2 extension study, according to Dr. Ferris. The most common complaints with JNJ-2113, such as nasopharyngitis (18.1% vs 25.7% in placebo), did not appear to differ significantly from placebo and the treatment remained well tolerated over the course of the extended follow-up.
There are limited direct comparisons of different biologics active in the treatment of plaque psoriasis for efficacy and safety, but these data appear to show a depth and durability of benefit for psoriasis that is exceptional, Dr. Lebwohl told this news organization. “The PASI 100 scores achieved by bimekizumab exceed anything we have seen to date,” he said. “And the durability of those exceedingly high scores is remarkable.”
Dr. Lebwohl reports financial relationships with approximately 40 pharmaceutical companies, including UCB Pharma, which developed bimekizumab. Dr. Ferris reports financial relationships with more than 20 pharmaceutical companies, including Janssen, which is developing JNJ-2113.
A version of this article appeared on Medscape.com.
SAN DIEGO — , but late-breaker data presented at the annual meeting of the American Academy of Dermatology show that these types of responses are sustained for as long as patients have remained on therapy.
Of the two, the longer follow up is with the IL-17 inhibitor bimekizumab (Bimzelx). In a 4-year open-label extension study, the Psoriasis Area and Severity Index (PASI) 90 rate was approximately 85% in treated patients, according to Mark Lebwohl, MD, professor and chairman emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York City
A PASI 90 score signifies that 90% of skin surface area is cleared. The proportion of patients who achieved a PASI 100 score, signifying total clearance, approached 70% at 4 years in the group with the greatest response. PASI 90 and PASI 100 rates at this point were only modestly lower than those reported at the end of the double-blind phase 3 trial when evaluated 3 years earlier.
Follow-up with a novel oral anti-IL-23 inhibitor JNJ-2113 (JNJ-77242113) was only 52 weeks, far shorter. But again, the response for the most effective dose at the end of this period was essentially unchanged from that at 16 weeks. Among those on the highest and most effective test dose of once-daily 100 mg, the PASI 90 at 1 year was 64.3%, a rate that was essentially unchanged from week 16.
No Apparent Loss of Benefit Over Time
“We can really look at those dose-response curves and see that there is, overall, a maintenance of response,” reported Laura K. Ferris, MD, PhD, professor and director of clinical trials, Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. In her presentation of the data, she showed similar sustained control for the most effective doses of JNJ-2113 for multiple clinical outcomes, including an investigator’s global assessment (IGA) score of 0 or 1, also signifying clear or near clear skin.
Bimekizumab, a monoclonal antibody that inhibits both IL-17A and IL-17F, is already approved for the treatment of plaque psoriasis. The 52-week BE SURE trial, which provided the 478 patients who entered into the BE BRIGHT open label extension study, was published in The New England Journal of Medicine in July 2021.
In the 4-year data reported by Dr. Lebwohl, three groups were compared: Those initially randomized to an every-4-week dosing schedule of bimekizumab over the course of the 52-week BE SURE trial; those randomized to an every-4-week bimekizumab schedule who were then subsequently switched to an every-8-week schedule; and those initiated on the TNF-inhibitor adalimumab (Humira) and were then switched at week 24 to every-4-week bimekizumab.
The PASI 90 responses at 52 weeks in these three groups, respectively, were 91.2%, 89.3%, and 95.2%. At 4 years, this almost clear response was observed in 82.4%, 83.2%, and 87.6%, respectively. At 52 weeks, the PASI 100 responses in these three groups, respectively, were 75.3%, 74.2%, and 72.9%. At 4 years, 61.9%, 58.5%, and 69.5% still had complete skin clearance.
Bimekizumab was well tolerated during the randomized trial, reported Dr. Lebwohl. The rates of nasopharyngitis and oral candidiasis, which were observed in approximately 12% and 8%, respectively, of treated patients during the randomized phase remained at about the same level in the long-term follow up. There were no new safety signals, he said.
JNJ-2113 Is First Potential Oral IL-23 Inhibitor
JNJ-2113 is a first-in-class oral peptide that binds to the IL-23 receptor, blocking the IL-23 signaling pathway. If approved, it would be the first oral therapy targeting IL-23. The 16-week outcomes of the dose-finding FRONTIER 1 phase 2b trial were published in The New England Journal of Medicine earlier this year. The primary endpoint was PASI 75, achieved by 79% of those on the 100 mg twice daily dose at week 16, vs 9% on placebo, and at 52 weeks, was 76%.
“The proportion of patients achieving the FRONTIER 1 primary endpoint was maintained from week 16 to the end of week 52 in the extension study,” Dr. Ferris said, but further pointed out that rates of near or complete clearance achieved at week 16 were also essentially unchanged at week 52. This was true of PASI scores and IGA.
Clearance of psoriatic lesions on the scalp was particularly impressive. By scalp-specific IGA, rates of clear or near clear (0/1) were not just maintained but improved over the course of follow-up, reaching 75.1% at 52 weeks in the highest dose group, she said.
JNJ-2113 was well tolerated in FRONTIER 1 and remained so during long-term follow-up, in the FRONTIER 2 extension study, according to Dr. Ferris. The most common complaints with JNJ-2113, such as nasopharyngitis (18.1% vs 25.7% in placebo), did not appear to differ significantly from placebo and the treatment remained well tolerated over the course of the extended follow-up.
There are limited direct comparisons of different biologics active in the treatment of plaque psoriasis for efficacy and safety, but these data appear to show a depth and durability of benefit for psoriasis that is exceptional, Dr. Lebwohl told this news organization. “The PASI 100 scores achieved by bimekizumab exceed anything we have seen to date,” he said. “And the durability of those exceedingly high scores is remarkable.”
Dr. Lebwohl reports financial relationships with approximately 40 pharmaceutical companies, including UCB Pharma, which developed bimekizumab. Dr. Ferris reports financial relationships with more than 20 pharmaceutical companies, including Janssen, which is developing JNJ-2113.
A version of this article appeared on Medscape.com.
FROM AAD 2024