TBD Meeting (3208-24)

WASHINGTON — After more than a decade, the American College of Rheumatology has developed new draft guidance for the use of musculoskeletal ultrasound (MSUS) to help with diagnosis, monitoring, and prognosis of rheumatoid arthritis (RA). Though not yet finalized, the statements that came out of a first round of committee voting were unveiled at the annual meeting of the American College of Rheumatology (ACR).

The committee was charged with updating the 2012 recommendations on using MSUS in rheumatology clinical practice, explained Veena K. Ranganath, MD, professor of clinical medicine at the University of California, Los Angeles, and director of their Rheumatology Fellowship Musculoskeletal Ultrasound Training Program. 

More than 30,000 articles on MSUS and any arthritis have been published since 2012, and there have been significant advances and improvements in technology as well as more widespread education and use in rheumatologic clinical practice, Ranganath said. 

“There’s also been advancements in therapeutic agents and therapeutic strategies in use of these medications in rheumatoid arthritis,” Ranganath said. “We all know that the patient of today is very different than the patient of 10 years ago or 20 years ago, so this really impacts the clinical questions we ask of how we need to incorporate musculoskeletal ultrasound into our rheumatology clinical practice.” 

The process of developing the guidance involved determining key domains and then relevant clinical questions for ultrasonography using the PICO model (patient/population, intervention, comparison, and outcomes). Evidence came from a review of relevant literature published since 1993 in PubMed, Embase, and the Cochrane Database. A panel of 11 experts voted on the quality of the evidence as being moderate or strong for 33 statements, rejecting three that had no consensus. The committee will hold another round of voting before the guidance is published.

Erin Arnold, MD, a rheumatologist at Arnold Arthritis & Rheumatology in Skokie, Illinois, said in an interview she believes the new guidance will be “tremendously helpful,” particularly in getting “everybody on the same page” with similar practices and helping enhance diagnosis and response to therapy. 

Having used MSUS for over 20 years, Arnold said watching it evolve and seeing “this type of manuscript being put together as a resource for physicians who are taking care of inflammatory arthritis is exciting.”

“There’s not a single way we really can assess disease activity in our patients, and so having a composite of things that you’re looking at really enhances our ability to understand people’s pain,” Arnold said. 

“When you have a patient in front of you that is in so much pain but doesn’t have any active inflammation, it’s hard to want to further put them at risk with more medication,” she said. “It’s so meaningful to be able to have a conversation about ... what are other complementary interventions? How are they sleeping? How are they eating? What are they taking as far as supplements? What are they doing to decrease that kind of fear and fight-or-flight response that often can drive some of our pain?” 

 

Use of MSUS for Diagnosis Confirmation and Treatment Decisions

Gurjit S. Kaeley, MBBS, professor of medicine, division chief of rheumatology and clinical immunology, and medical director of the Musculoskeletal Ultrasound Program at the University of Florida College of Medicine, Jacksonville, reviewed the final statements for MSUS use with RA.

He said there was strong consensus that adding MSUS to clinical examination can aid diagnosis of early RA in patients with suspected RA, particularly with detection of synovitis, tenosynovitis, and erosions. There was moderate consensus that MSUS detection of tenosynovitis could predict later development of RA. 

“Furthermore, erosions do have a predictive prognostic value in telling us that these patients need more attention and more urgent attention to getting urgent care with disease-modifying medications,” Kaeley said. “Ultrasound scanning for bone erosions on a few target joints was found to be feasible in literature and provides information not available with clinical examination. Furthermore, ultrasound is more sensitive than plain radiography for the detection of erosions.” 

Moderate consensus supported a cutoff of at least 2 mm for erosions when using MSUS for diagnostic purposes. 

Strong consensus supported using MSUS of the wrist, second and third metacarpophalangeal (MCP) joints, and second and third interphalangeal (PIP) joints to aid early RA diagnosis, with moderate consensus that cutoffs of least 2 grayscale (GS) or at least 1 GS with at least 1 power Doppler (PD) at the joint level supports both an RA diagnosis and, in patients already diagnosed with RA, a positive joint.

“Grayscale-only definitions were included since equipment may not have sensitive Doppler,” Kaeley said.

Strong consensus supported scanning only a reduced set of representative or symptomatic joints to monitor disease activity with MSUS. 

 

Inflammatory Signs, Disease Progression, and Flares

There was also strong consensus for using MSUS in patients with established RA and comorbidities to help distinguish between RA-related inflammation versus inflammation from other conditions, such as gout or calcium pyrophosphate deposition disease, or versus non–RA-related pain, such as that from fibromyalgia. 

Patients with fibromyalgia, for example, “tend to have more steroid exposure and a high prevalence of biologic use because the composite disease scores tend to overestimate disease activity, especially when compared to ultrasound assessment,” Kaeley said.

Moderate consensus supported using MSUS in patients with established RA to objectively evaluate inflammation so as to eliminate age-related bias.

While MSUS signs of synovitis had only moderate consensus to be associated with radiographic progression and decline in patient-reported outcomes for patients with early RA, consensus was strong for this association in patients with established RA.

In terms of predicting disease progression with MSUS monitoring of RA disease activity, moderate consensus supported scanning the wrists and MCPs and PIPs of the hands and using the dorsal view. Kaeley emphasized that ultrasound is a clinical tool that should be used to answer a clinical question, so the sonographer or clinician needs to provide guidance on the areas to be scanned. 

Multiple standardized scoring systems exist for predicting RA disease progression, but there is no consensus on which is the most effective, and there is only moderate consensus about the validity of using dichotomous scoring with an established cutoff for a positive joint.

The combination of MSUS with clinical examination appears to be more effective at confirming RA flares than using only clinical examination, and in certain patients with established RA, MSUS may provide insights into subclinical disease activity to help maintain remission and/or potentially guide treatment decisions, “especially when coming across de-escalation therapy decisions,” Kaeley said.

Despite the negative results of treat-to-target trials that tested MSUS as a routine tool in all patients, the committee achieved strong consensus on the potential value of using MSUS in early RA to clarify clinical status and/or help achieve low disease activity or remission in certain patient populations, “such as those with patient/provider discordance or difficult physical examinations,” Kaeley said. 

 

Therapy Response, Remission, and Shared Decision-Making

Moderate consensus supported acknowledgment that using MSUS to assess response to therapy could be affected by obesity and that MSUS can distinguish active synovitis symptoms from other pain sources in difficult-to-treat RA.

In patients with established RA, the feasibility of scanning the wrists, MCPs, PIPs, and relevant symptomatic joints for remission evaluation received moderate consensus. Meanwhile, strong consensus supported the idea that increasing the number of joints scanned with MSUS could increase the certainty of the patient having achieved remission, though the guidance acknowledges that “this must be balanced against the feasibility within the context of clinical care.” 

For confirming RA remission via MSUS, strong consensus supported using GS and PD synovitis and tenosynovitis findings. But consensus was moderate for using the combination of no PD signal and minimal synovial hypertrophy to define ultrasonographic remission and for the use of MSUS detection of subclinical inflammation to predict higher flare rates for those in clinical remission.

The committee moderately agreed that MSUS can enhance patient engagement and understanding of their disease to support personalized treatment decisions, such as adjusting disease-modifying antirheumatic drug regimens.

Finally, the committee broadly agreed that “the integration of musculoskeletal ultrasound presents significant advantages in shared decision-making between healthcare providers and patients,” Kaeley said. “Ultrasound, especially with Doppler technique, provides critical insights into disease activity and structural changes not always apparent during standard examination.” 

Arnold said she particularly appreciated that the committee, rather than prescribing a specific exam, opted to be more generalizable so that people use the guidance in the context that makes the most sense for them clinically. She said it’s an incredible tool, without excluding the importance of a patient’s labs and physical examination. 

“It’s helped us make diagnoses in patients who were difficult to diagnose. It’s helped us to understand response to therapy or no response to therapy,” she said. “It makes me question all the studies that I see done on medications where they’re not looking at some type of advanced imaging.” 

No external funding was noted for the development of the guidance. Ranganath has reported receiving research support from Bristol-Myers Squibb and Mallinckrodt. Kaeley has reported receiving research funding from AbbVie, Bristol-Myers Squibb, Gilead/Galapagos, Janssen, and Novartis. Arnold had no disclosures.

A version of this article first appeared on Medscape.com.

WASHINGTON — After more than a decade, the American College of Rheumatology has developed new draft guidance for the use of musculoskeletal ultrasound (MSUS) to help with diagnosis, monitoring, and prognosis of rheumatoid arthritis (RA). Though not yet finalized, the statements that came out of a first round of committee voting were unveiled at the annual meeting of the American College of Rheumatology (ACR).

The committee was charged with updating the 2012 recommendations on using MSUS in rheumatology clinical practice, explained Veena K. Ranganath, MD, professor of clinical medicine at the University of California, Los Angeles, and director of their Rheumatology Fellowship Musculoskeletal Ultrasound Training Program. 

More than 30,000 articles on MSUS and any arthritis have been published since 2012, and there have been significant advances and improvements in technology as well as more widespread education and use in rheumatologic clinical practice, Ranganath said. 

“There’s also been advancements in therapeutic agents and therapeutic strategies in use of these medications in rheumatoid arthritis,” Ranganath said. “We all know that the patient of today is very different than the patient of 10 years ago or 20 years ago, so this really impacts the clinical questions we ask of how we need to incorporate musculoskeletal ultrasound into our rheumatology clinical practice.” 

The process of developing the guidance involved determining key domains and then relevant clinical questions for ultrasonography using the PICO model (patient/population, intervention, comparison, and outcomes). Evidence came from a review of relevant literature published since 1993 in PubMed, Embase, and the Cochrane Database. A panel of 11 experts voted on the quality of the evidence as being moderate or strong for 33 statements, rejecting three that had no consensus. The committee will hold another round of voting before the guidance is published.

Erin Arnold, MD, a rheumatologist at Arnold Arthritis & Rheumatology in Skokie, Illinois, said in an interview she believes the new guidance will be “tremendously helpful,” particularly in getting “everybody on the same page” with similar practices and helping enhance diagnosis and response to therapy. 

Having used MSUS for over 20 years, Arnold said watching it evolve and seeing “this type of manuscript being put together as a resource for physicians who are taking care of inflammatory arthritis is exciting.”

“There’s not a single way we really can assess disease activity in our patients, and so having a composite of things that you’re looking at really enhances our ability to understand people’s pain,” Arnold said. 

“When you have a patient in front of you that is in so much pain but doesn’t have any active inflammation, it’s hard to want to further put them at risk with more medication,” she said. “It’s so meaningful to be able to have a conversation about ... what are other complementary interventions? How are they sleeping? How are they eating? What are they taking as far as supplements? What are they doing to decrease that kind of fear and fight-or-flight response that often can drive some of our pain?” 

 

Use of MSUS for Diagnosis Confirmation and Treatment Decisions

Gurjit S. Kaeley, MBBS, professor of medicine, division chief of rheumatology and clinical immunology, and medical director of the Musculoskeletal Ultrasound Program at the University of Florida College of Medicine, Jacksonville, reviewed the final statements for MSUS use with RA.

He said there was strong consensus that adding MSUS to clinical examination can aid diagnosis of early RA in patients with suspected RA, particularly with detection of synovitis, tenosynovitis, and erosions. There was moderate consensus that MSUS detection of tenosynovitis could predict later development of RA. 

“Furthermore, erosions do have a predictive prognostic value in telling us that these patients need more attention and more urgent attention to getting urgent care with disease-modifying medications,” Kaeley said. “Ultrasound scanning for bone erosions on a few target joints was found to be feasible in literature and provides information not available with clinical examination. Furthermore, ultrasound is more sensitive than plain radiography for the detection of erosions.” 

Moderate consensus supported a cutoff of at least 2 mm for erosions when using MSUS for diagnostic purposes. 

Strong consensus supported using MSUS of the wrist, second and third metacarpophalangeal (MCP) joints, and second and third interphalangeal (PIP) joints to aid early RA diagnosis, with moderate consensus that cutoffs of least 2 grayscale (GS) or at least 1 GS with at least 1 power Doppler (PD) at the joint level supports both an RA diagnosis and, in patients already diagnosed with RA, a positive joint.

“Grayscale-only definitions were included since equipment may not have sensitive Doppler,” Kaeley said.

Strong consensus supported scanning only a reduced set of representative or symptomatic joints to monitor disease activity with MSUS. 

 

Inflammatory Signs, Disease Progression, and Flares

There was also strong consensus for using MSUS in patients with established RA and comorbidities to help distinguish between RA-related inflammation versus inflammation from other conditions, such as gout or calcium pyrophosphate deposition disease, or versus non–RA-related pain, such as that from fibromyalgia. 

Patients with fibromyalgia, for example, “tend to have more steroid exposure and a high prevalence of biologic use because the composite disease scores tend to overestimate disease activity, especially when compared to ultrasound assessment,” Kaeley said.

Moderate consensus supported using MSUS in patients with established RA to objectively evaluate inflammation so as to eliminate age-related bias.

While MSUS signs of synovitis had only moderate consensus to be associated with radiographic progression and decline in patient-reported outcomes for patients with early RA, consensus was strong for this association in patients with established RA.

In terms of predicting disease progression with MSUS monitoring of RA disease activity, moderate consensus supported scanning the wrists and MCPs and PIPs of the hands and using the dorsal view. Kaeley emphasized that ultrasound is a clinical tool that should be used to answer a clinical question, so the sonographer or clinician needs to provide guidance on the areas to be scanned. 

Multiple standardized scoring systems exist for predicting RA disease progression, but there is no consensus on which is the most effective, and there is only moderate consensus about the validity of using dichotomous scoring with an established cutoff for a positive joint.

The combination of MSUS with clinical examination appears to be more effective at confirming RA flares than using only clinical examination, and in certain patients with established RA, MSUS may provide insights into subclinical disease activity to help maintain remission and/or potentially guide treatment decisions, “especially when coming across de-escalation therapy decisions,” Kaeley said.

Despite the negative results of treat-to-target trials that tested MSUS as a routine tool in all patients, the committee achieved strong consensus on the potential value of using MSUS in early RA to clarify clinical status and/or help achieve low disease activity or remission in certain patient populations, “such as those with patient/provider discordance or difficult physical examinations,” Kaeley said. 

 

Therapy Response, Remission, and Shared Decision-Making

Moderate consensus supported acknowledgment that using MSUS to assess response to therapy could be affected by obesity and that MSUS can distinguish active synovitis symptoms from other pain sources in difficult-to-treat RA.

In patients with established RA, the feasibility of scanning the wrists, MCPs, PIPs, and relevant symptomatic joints for remission evaluation received moderate consensus. Meanwhile, strong consensus supported the idea that increasing the number of joints scanned with MSUS could increase the certainty of the patient having achieved remission, though the guidance acknowledges that “this must be balanced against the feasibility within the context of clinical care.” 

For confirming RA remission via MSUS, strong consensus supported using GS and PD synovitis and tenosynovitis findings. But consensus was moderate for using the combination of no PD signal and minimal synovial hypertrophy to define ultrasonographic remission and for the use of MSUS detection of subclinical inflammation to predict higher flare rates for those in clinical remission.

The committee moderately agreed that MSUS can enhance patient engagement and understanding of their disease to support personalized treatment decisions, such as adjusting disease-modifying antirheumatic drug regimens.

Finally, the committee broadly agreed that “the integration of musculoskeletal ultrasound presents significant advantages in shared decision-making between healthcare providers and patients,” Kaeley said. “Ultrasound, especially with Doppler technique, provides critical insights into disease activity and structural changes not always apparent during standard examination.” 

Arnold said she particularly appreciated that the committee, rather than prescribing a specific exam, opted to be more generalizable so that people use the guidance in the context that makes the most sense for them clinically. She said it’s an incredible tool, without excluding the importance of a patient’s labs and physical examination. 

“It’s helped us make diagnoses in patients who were difficult to diagnose. It’s helped us to understand response to therapy or no response to therapy,” she said. “It makes me question all the studies that I see done on medications where they’re not looking at some type of advanced imaging.” 

No external funding was noted for the development of the guidance. Ranganath has reported receiving research support from Bristol-Myers Squibb and Mallinckrodt. Kaeley has reported receiving research funding from AbbVie, Bristol-Myers Squibb, Gilead/Galapagos, Janssen, and Novartis. Arnold had no disclosures.

A version of this article first appeared on Medscape.com.

WASHINGTON — After more than a decade, the American College of Rheumatology has developed new draft guidance for the use of musculoskeletal ultrasound (MSUS) to help with diagnosis, monitoring, and prognosis of rheumatoid arthritis (RA). Though not yet finalized, the statements that came out of a first round of committee voting were unveiled at the annual meeting of the American College of Rheumatology (ACR).

The committee was charged with updating the 2012 recommendations on using MSUS in rheumatology clinical practice, explained Veena K. Ranganath, MD, professor of clinical medicine at the University of California, Los Angeles, and director of their Rheumatology Fellowship Musculoskeletal Ultrasound Training Program. 

More than 30,000 articles on MSUS and any arthritis have been published since 2012, and there have been significant advances and improvements in technology as well as more widespread education and use in rheumatologic clinical practice, Ranganath said. 

“There’s also been advancements in therapeutic agents and therapeutic strategies in use of these medications in rheumatoid arthritis,” Ranganath said. “We all know that the patient of today is very different than the patient of 10 years ago or 20 years ago, so this really impacts the clinical questions we ask of how we need to incorporate musculoskeletal ultrasound into our rheumatology clinical practice.” 

The process of developing the guidance involved determining key domains and then relevant clinical questions for ultrasonography using the PICO model (patient/population, intervention, comparison, and outcomes). Evidence came from a review of relevant literature published since 1993 in PubMed, Embase, and the Cochrane Database. A panel of 11 experts voted on the quality of the evidence as being moderate or strong for 33 statements, rejecting three that had no consensus. The committee will hold another round of voting before the guidance is published.

Erin Arnold, MD, a rheumatologist at Arnold Arthritis & Rheumatology in Skokie, Illinois, said in an interview she believes the new guidance will be “tremendously helpful,” particularly in getting “everybody on the same page” with similar practices and helping enhance diagnosis and response to therapy. 

Having used MSUS for over 20 years, Arnold said watching it evolve and seeing “this type of manuscript being put together as a resource for physicians who are taking care of inflammatory arthritis is exciting.”

“There’s not a single way we really can assess disease activity in our patients, and so having a composite of things that you’re looking at really enhances our ability to understand people’s pain,” Arnold said. 

“When you have a patient in front of you that is in so much pain but doesn’t have any active inflammation, it’s hard to want to further put them at risk with more medication,” she said. “It’s so meaningful to be able to have a conversation about ... what are other complementary interventions? How are they sleeping? How are they eating? What are they taking as far as supplements? What are they doing to decrease that kind of fear and fight-or-flight response that often can drive some of our pain?” 

 

Use of MSUS for Diagnosis Confirmation and Treatment Decisions

Gurjit S. Kaeley, MBBS, professor of medicine, division chief of rheumatology and clinical immunology, and medical director of the Musculoskeletal Ultrasound Program at the University of Florida College of Medicine, Jacksonville, reviewed the final statements for MSUS use with RA.

He said there was strong consensus that adding MSUS to clinical examination can aid diagnosis of early RA in patients with suspected RA, particularly with detection of synovitis, tenosynovitis, and erosions. There was moderate consensus that MSUS detection of tenosynovitis could predict later development of RA. 

“Furthermore, erosions do have a predictive prognostic value in telling us that these patients need more attention and more urgent attention to getting urgent care with disease-modifying medications,” Kaeley said. “Ultrasound scanning for bone erosions on a few target joints was found to be feasible in literature and provides information not available with clinical examination. Furthermore, ultrasound is more sensitive than plain radiography for the detection of erosions.” 

Moderate consensus supported a cutoff of at least 2 mm for erosions when using MSUS for diagnostic purposes. 

Strong consensus supported using MSUS of the wrist, second and third metacarpophalangeal (MCP) joints, and second and third interphalangeal (PIP) joints to aid early RA diagnosis, with moderate consensus that cutoffs of least 2 grayscale (GS) or at least 1 GS with at least 1 power Doppler (PD) at the joint level supports both an RA diagnosis and, in patients already diagnosed with RA, a positive joint.

“Grayscale-only definitions were included since equipment may not have sensitive Doppler,” Kaeley said.

Strong consensus supported scanning only a reduced set of representative or symptomatic joints to monitor disease activity with MSUS. 

 

Inflammatory Signs, Disease Progression, and Flares

There was also strong consensus for using MSUS in patients with established RA and comorbidities to help distinguish between RA-related inflammation versus inflammation from other conditions, such as gout or calcium pyrophosphate deposition disease, or versus non–RA-related pain, such as that from fibromyalgia. 

Patients with fibromyalgia, for example, “tend to have more steroid exposure and a high prevalence of biologic use because the composite disease scores tend to overestimate disease activity, especially when compared to ultrasound assessment,” Kaeley said.

Moderate consensus supported using MSUS in patients with established RA to objectively evaluate inflammation so as to eliminate age-related bias.

While MSUS signs of synovitis had only moderate consensus to be associated with radiographic progression and decline in patient-reported outcomes for patients with early RA, consensus was strong for this association in patients with established RA.

In terms of predicting disease progression with MSUS monitoring of RA disease activity, moderate consensus supported scanning the wrists and MCPs and PIPs of the hands and using the dorsal view. Kaeley emphasized that ultrasound is a clinical tool that should be used to answer a clinical question, so the sonographer or clinician needs to provide guidance on the areas to be scanned. 

Multiple standardized scoring systems exist for predicting RA disease progression, but there is no consensus on which is the most effective, and there is only moderate consensus about the validity of using dichotomous scoring with an established cutoff for a positive joint.

The combination of MSUS with clinical examination appears to be more effective at confirming RA flares than using only clinical examination, and in certain patients with established RA, MSUS may provide insights into subclinical disease activity to help maintain remission and/or potentially guide treatment decisions, “especially when coming across de-escalation therapy decisions,” Kaeley said.

Despite the negative results of treat-to-target trials that tested MSUS as a routine tool in all patients, the committee achieved strong consensus on the potential value of using MSUS in early RA to clarify clinical status and/or help achieve low disease activity or remission in certain patient populations, “such as those with patient/provider discordance or difficult physical examinations,” Kaeley said. 

 

Therapy Response, Remission, and Shared Decision-Making

Moderate consensus supported acknowledgment that using MSUS to assess response to therapy could be affected by obesity and that MSUS can distinguish active synovitis symptoms from other pain sources in difficult-to-treat RA.

In patients with established RA, the feasibility of scanning the wrists, MCPs, PIPs, and relevant symptomatic joints for remission evaluation received moderate consensus. Meanwhile, strong consensus supported the idea that increasing the number of joints scanned with MSUS could increase the certainty of the patient having achieved remission, though the guidance acknowledges that “this must be balanced against the feasibility within the context of clinical care.” 

For confirming RA remission via MSUS, strong consensus supported using GS and PD synovitis and tenosynovitis findings. But consensus was moderate for using the combination of no PD signal and minimal synovial hypertrophy to define ultrasonographic remission and for the use of MSUS detection of subclinical inflammation to predict higher flare rates for those in clinical remission.

The committee moderately agreed that MSUS can enhance patient engagement and understanding of their disease to support personalized treatment decisions, such as adjusting disease-modifying antirheumatic drug regimens.

Finally, the committee broadly agreed that “the integration of musculoskeletal ultrasound presents significant advantages in shared decision-making between healthcare providers and patients,” Kaeley said. “Ultrasound, especially with Doppler technique, provides critical insights into disease activity and structural changes not always apparent during standard examination.” 

Arnold said she particularly appreciated that the committee, rather than prescribing a specific exam, opted to be more generalizable so that people use the guidance in the context that makes the most sense for them clinically. She said it’s an incredible tool, without excluding the importance of a patient’s labs and physical examination. 

“It’s helped us make diagnoses in patients who were difficult to diagnose. It’s helped us to understand response to therapy or no response to therapy,” she said. “It makes me question all the studies that I see done on medications where they’re not looking at some type of advanced imaging.” 

No external funding was noted for the development of the guidance. Ranganath has reported receiving research support from Bristol-Myers Squibb and Mallinckrodt. Kaeley has reported receiving research funding from AbbVie, Bristol-Myers Squibb, Gilead/Galapagos, Janssen, and Novartis. Arnold had no disclosures.

A version of this article first appeared on Medscape.com.

WASHINGTON — Patients with granulomatosis with polyangiitis (GPA) completely tapered off prednisone have a more than fourfold risk of relapse by 6 months, compared with those tapered to 5 mg/day of prednisone; however, this benefit was only seen in patients not on rituximab, according to new research presented at the annual meeting of the American College of Rheumatology (ACR).

“For patients treated with rituximab, fully tapering off glucocorticoids is reasonable to consider as the first approach,” said Peter Merkel, MD, MPH, chief of the division of rheumatology at the University of Pennsylvania, Philadelphia, during his presentation of the findings.

Although a low dose of glucocorticoids can prevent some minor relapses in patients on other treatment regimens such as methotrexate or azathioprine, “fully tapering off prednisone presents relatively little risk of major relapse, and that major relapse can be treated rather quickly,” Merkel added.

The Assessment of Prednisone in Remission (TAPIR) trial enrolled 143 patients with GPA who were in remission (defined as a Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis [BVAS/WG] of 0) within 1 year of treatment to induce remission for active disease and who were taking 5-10 mg of prednisone per day. After all patients tapered to 5 mg/day of prednisone, 71 patients completely tapered off prednisone over 4 weeks and remained off glucocorticoids until month 6. The remaining patients maintained a 5-mg/day dose over the study period. Placement in either treatment group was randomized, and patients continued other immunosuppressive therapy during the study.

Researchers evaluated the rate of relapse by 6 months, defined as a physician’s decision to increase the dose of glucocorticoids to treat GPA, in both groups.

Across all participants, the median age was 58 years, and 52% of patients were male. Most patients were White, and 47% of all patients were prescribed rituximab. 

At 6 months, 15.5% of participants who completely tapered off prednisone experienced a relapse of GPA, compared with 4.2% of those taking low-dose prednisone. Time to relapse was also shorter in the 0-mg prednisone group (P = .026), and relapses occurred continually over 6 months, Merkel said.

When stratified by rituximab use, relapse rates at 6 months between the 5-mg and 0-mg prednisone groups in patients taking rituximab showed no difference. Among patients not taking rituximab, those who completely stopped prednisone were nine and a half times as likely to experience relapse as those in the low-dose group. 

Despite these differences in relapse rates, “surprisingly, there were no differences in patient-reported outcomes [such as pain interference, physical function, and fatigue],” Merkel said. 

Across all patients, all but one relapse was characterized as minor. There were five serious adverse events and 10 infections in the 0-mg group versus one adverse event and 4 infections in the 5-mg group, but these differences were not statistically significant. 

In patients who relapsed, musculoskeletal and ear, nose, and throat manifestations of GPA were most common, and these are “the kind of stuff we see that is helped by low-dose glucocorticoids,” Merkel said.

It’s a good sign that for patients who were completely weaned off glucocorticoids, nearly all relapses were minor, Galina Marder, MD, a rheumatologist and associate professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said in an interview. She was not involved with the research. 

The study “can reinforce the message [of] trying to get them off steroids completely [when possible],” she said.

The findings also provide insight for future clinical trials, Merkel noted. For patients taking non–rituximab-based regimens, completely tapering off glucocorticoids or maintaining a low dose can affect study outcomes.

“[These data are] even more important for clinical trials because they are [reinforcing] the fact that you can have a diminishing signal if you allow some patients to stay on 5 mg prednisone” when GPA flares are the primary outcome, Marder added.

The Vasculitis Clinical Research Consortium received funding for this research through grants from the National Institutes of Health. Merkel has disclosed financial relationships with AbbVie/Abbott, Amgen, argenx, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cabaletta, ChemoCentryx, CSL Behring, Dynacure, Eicos, Electra, EMD Serono, Forbius, Genentech/Roche, Genzyme/Sanofi, GSK, HI-Bio, Inmagene, InflaRx, Janssen, Kiniksa, Kyverna, Magenta, MiroBio, Neutrolis, Novartis, NS Pharma, Pfizer, Regeneron, Sanofi, Sparrow, Takeda, Talaris, UpToDate, and Visterra. Marder consults for Amgen and Boehringer Ingelheim.

A version of this article first appeared on Medscape.com.

WASHINGTON — Patients with granulomatosis with polyangiitis (GPA) completely tapered off prednisone have a more than fourfold risk of relapse by 6 months, compared with those tapered to 5 mg/day of prednisone; however, this benefit was only seen in patients not on rituximab, according to new research presented at the annual meeting of the American College of Rheumatology (ACR).

“For patients treated with rituximab, fully tapering off glucocorticoids is reasonable to consider as the first approach,” said Peter Merkel, MD, MPH, chief of the division of rheumatology at the University of Pennsylvania, Philadelphia, during his presentation of the findings.

Although a low dose of glucocorticoids can prevent some minor relapses in patients on other treatment regimens such as methotrexate or azathioprine, “fully tapering off prednisone presents relatively little risk of major relapse, and that major relapse can be treated rather quickly,” Merkel added.

The Assessment of Prednisone in Remission (TAPIR) trial enrolled 143 patients with GPA who were in remission (defined as a Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis [BVAS/WG] of 0) within 1 year of treatment to induce remission for active disease and who were taking 5-10 mg of prednisone per day. After all patients tapered to 5 mg/day of prednisone, 71 patients completely tapered off prednisone over 4 weeks and remained off glucocorticoids until month 6. The remaining patients maintained a 5-mg/day dose over the study period. Placement in either treatment group was randomized, and patients continued other immunosuppressive therapy during the study.

Researchers evaluated the rate of relapse by 6 months, defined as a physician’s decision to increase the dose of glucocorticoids to treat GPA, in both groups.

Across all participants, the median age was 58 years, and 52% of patients were male. Most patients were White, and 47% of all patients were prescribed rituximab. 

At 6 months, 15.5% of participants who completely tapered off prednisone experienced a relapse of GPA, compared with 4.2% of those taking low-dose prednisone. Time to relapse was also shorter in the 0-mg prednisone group (P = .026), and relapses occurred continually over 6 months, Merkel said.

When stratified by rituximab use, relapse rates at 6 months between the 5-mg and 0-mg prednisone groups in patients taking rituximab showed no difference. Among patients not taking rituximab, those who completely stopped prednisone were nine and a half times as likely to experience relapse as those in the low-dose group. 

Despite these differences in relapse rates, “surprisingly, there were no differences in patient-reported outcomes [such as pain interference, physical function, and fatigue],” Merkel said. 

Across all patients, all but one relapse was characterized as minor. There were five serious adverse events and 10 infections in the 0-mg group versus one adverse event and 4 infections in the 5-mg group, but these differences were not statistically significant. 

In patients who relapsed, musculoskeletal and ear, nose, and throat manifestations of GPA were most common, and these are “the kind of stuff we see that is helped by low-dose glucocorticoids,” Merkel said.

It’s a good sign that for patients who were completely weaned off glucocorticoids, nearly all relapses were minor, Galina Marder, MD, a rheumatologist and associate professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said in an interview. She was not involved with the research. 

The study “can reinforce the message [of] trying to get them off steroids completely [when possible],” she said.

The findings also provide insight for future clinical trials, Merkel noted. For patients taking non–rituximab-based regimens, completely tapering off glucocorticoids or maintaining a low dose can affect study outcomes.

“[These data are] even more important for clinical trials because they are [reinforcing] the fact that you can have a diminishing signal if you allow some patients to stay on 5 mg prednisone” when GPA flares are the primary outcome, Marder added.

The Vasculitis Clinical Research Consortium received funding for this research through grants from the National Institutes of Health. Merkel has disclosed financial relationships with AbbVie/Abbott, Amgen, argenx, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cabaletta, ChemoCentryx, CSL Behring, Dynacure, Eicos, Electra, EMD Serono, Forbius, Genentech/Roche, Genzyme/Sanofi, GSK, HI-Bio, Inmagene, InflaRx, Janssen, Kiniksa, Kyverna, Magenta, MiroBio, Neutrolis, Novartis, NS Pharma, Pfizer, Regeneron, Sanofi, Sparrow, Takeda, Talaris, UpToDate, and Visterra. Marder consults for Amgen and Boehringer Ingelheim.

A version of this article first appeared on Medscape.com.

WASHINGTON — Patients with granulomatosis with polyangiitis (GPA) completely tapered off prednisone have a more than fourfold risk of relapse by 6 months, compared with those tapered to 5 mg/day of prednisone; however, this benefit was only seen in patients not on rituximab, according to new research presented at the annual meeting of the American College of Rheumatology (ACR).

“For patients treated with rituximab, fully tapering off glucocorticoids is reasonable to consider as the first approach,” said Peter Merkel, MD, MPH, chief of the division of rheumatology at the University of Pennsylvania, Philadelphia, during his presentation of the findings.

Although a low dose of glucocorticoids can prevent some minor relapses in patients on other treatment regimens such as methotrexate or azathioprine, “fully tapering off prednisone presents relatively little risk of major relapse, and that major relapse can be treated rather quickly,” Merkel added.

The Assessment of Prednisone in Remission (TAPIR) trial enrolled 143 patients with GPA who were in remission (defined as a Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis [BVAS/WG] of 0) within 1 year of treatment to induce remission for active disease and who were taking 5-10 mg of prednisone per day. After all patients tapered to 5 mg/day of prednisone, 71 patients completely tapered off prednisone over 4 weeks and remained off glucocorticoids until month 6. The remaining patients maintained a 5-mg/day dose over the study period. Placement in either treatment group was randomized, and patients continued other immunosuppressive therapy during the study.

Researchers evaluated the rate of relapse by 6 months, defined as a physician’s decision to increase the dose of glucocorticoids to treat GPA, in both groups.

Across all participants, the median age was 58 years, and 52% of patients were male. Most patients were White, and 47% of all patients were prescribed rituximab. 

At 6 months, 15.5% of participants who completely tapered off prednisone experienced a relapse of GPA, compared with 4.2% of those taking low-dose prednisone. Time to relapse was also shorter in the 0-mg prednisone group (P = .026), and relapses occurred continually over 6 months, Merkel said.

When stratified by rituximab use, relapse rates at 6 months between the 5-mg and 0-mg prednisone groups in patients taking rituximab showed no difference. Among patients not taking rituximab, those who completely stopped prednisone were nine and a half times as likely to experience relapse as those in the low-dose group. 

Despite these differences in relapse rates, “surprisingly, there were no differences in patient-reported outcomes [such as pain interference, physical function, and fatigue],” Merkel said. 

Across all patients, all but one relapse was characterized as minor. There were five serious adverse events and 10 infections in the 0-mg group versus one adverse event and 4 infections in the 5-mg group, but these differences were not statistically significant. 

In patients who relapsed, musculoskeletal and ear, nose, and throat manifestations of GPA were most common, and these are “the kind of stuff we see that is helped by low-dose glucocorticoids,” Merkel said.

It’s a good sign that for patients who were completely weaned off glucocorticoids, nearly all relapses were minor, Galina Marder, MD, a rheumatologist and associate professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said in an interview. She was not involved with the research. 

The study “can reinforce the message [of] trying to get them off steroids completely [when possible],” she said.

The findings also provide insight for future clinical trials, Merkel noted. For patients taking non–rituximab-based regimens, completely tapering off glucocorticoids or maintaining a low dose can affect study outcomes.

“[These data are] even more important for clinical trials because they are [reinforcing] the fact that you can have a diminishing signal if you allow some patients to stay on 5 mg prednisone” when GPA flares are the primary outcome, Marder added.

The Vasculitis Clinical Research Consortium received funding for this research through grants from the National Institutes of Health. Merkel has disclosed financial relationships with AbbVie/Abbott, Amgen, argenx, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cabaletta, ChemoCentryx, CSL Behring, Dynacure, Eicos, Electra, EMD Serono, Forbius, Genentech/Roche, Genzyme/Sanofi, GSK, HI-Bio, Inmagene, InflaRx, Janssen, Kiniksa, Kyverna, Magenta, MiroBio, Neutrolis, Novartis, NS Pharma, Pfizer, Regeneron, Sanofi, Sparrow, Takeda, Talaris, UpToDate, and Visterra. Marder consults for Amgen and Boehringer Ingelheim.

A version of this article first appeared on Medscape.com.