WASHINGTON — Patients affected Wegener’s granulomatosis (GPA) has completely declined prednisone have a risk of relapse more than four times greater at 6 months compared to those reduced to 5 mg/day of prednisone; however, this benefit was only observed in patients who were not taking rituximabaccording to new research presented at American College of Rheumatology (ACR) Annual Meeting 2024.

“For patients treated with rituximab, it is reasonable to consider a complete reduction of glucocorticoids as a first approach,” said Peter Merkel, MD, MPH, chief of the division of rheumatology at the University of Pennsylvania in Philadelphia, during its presentation of the results.

Although a low dose of glucocorticoids may prevent some minor relapses in patients on other treatment regimens such as methotrexate Or azathioprine“Complete reduction of prednisone has relatively little risk of major relapse, and major relapse can be treated relatively quickly,” Merkel added.

The Trial of Prednisone Assessment in Remission (TAPIR) enrolled 143 patients with GPA in remission (defined as Birmingham score Vasculitis Activity score for Wegener’s granulomatosis (BVAS/WG) of 0) within 1 year of treatment to induce remission of active disease and who were taking 5 to 10 mg of prednisone daily. After all patients gradually reduced their dose to 5 mg/day of prednisone, 71 patients stopped prednisone completely over a 4-week period and remained glucocorticoid-free until month 6. The remaining patients maintained a dose of 5 mg/day during the study period. Placement in either treatment group was randomized, and patients continued on another immunosuppressive therapy during the study.

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

Among 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 stopped prednisone experienced a GPA relapse, compared to 4.2% of those taking low-dose prednisone. The time to relapse was also shorter in the prednisone 0 mg group (P. = 0.026), and relapses occurred continuously for 6 months, Merkel said.

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

In all patients, all but one relapse was classified as minor. There were five serious adverse events and 10 infections in the 0 mg group compared to one adverse event and four 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 kinds of things we see that are helped by glucocorticoids to low dose,” Merkel said.

It’s a good sign that in patients completely weaned off glucocorticoids, almost 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 Medscape Medical News. She did not participate in the research.

The study “may reinforce the message of trying to get them off steroids completely (when possible),” she said.

The results also provide insight into future clinical trials, Merkel noted. For patients taking non-rituximab regimens, completely reducing glucocorticoids or maintaining a low dose may affect study results.

“(This data is) even more important for clinical trials because it (reinforces) the fact that you can have a decreasing signal if you allow some patients to continue taking 5 mg of prednisone” when GPA flares are the main result, Marder added.

The Vasculitis Clinical Research Consortium received funding for this research through grants from the U.S. National Institutes of Health. Merkel disclosed her 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 is a consultant for Amgen and Boehringer Ingelheim.