TOPLINE:

Rituximab is not superior to azathioprine for maintaining remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA), according to results from a small double-blind, randomized, controlled phase 3 study.

METHODOLOGY:

• Researchers enrolled 98 patients with newly diagnosed EGPA or who had experienced a flare in the past year, but who were in remission following an induction regimen, into a double-blind, randomized, controlled phase 3 study (MAINRITSEG) to compare the effects of rituximab or azathioprine on the duration of remission in patients with EGPA.
• Participants were randomly assigned to receive either 500 mg of rituximab every 6 months for 18 months plus an oral placebo for 24 months or 2 mg/kg/d azathioprine for 24 months plus a placebo infusion every 6 months for 18 months.
• The primary endpoint was the accrued number of weeks that the patient remained in remission, defined as no new disease activity and a prednisone dose ≤ 7.5 mg/d, over the 28-month study.

TAKEAWAY:

• There was no significant difference between the rituximab- and azathioprine-treated patients in the total amount of remission time, relapse rate, or the time to relapse or in secondary outcomes including asthma or rhinosinusitis exacerbations or prednisone dose.
• If the definition of remission was tightened to include a prednisone dose ≤ 4 mg/d instead of 7.5 mg/d, rituximab therapy was associated with a higher cumulative time in remission by the 28-month mark.
• The study saw no significant differences in the rate of adverse events or severe adverse events between the two groups.
• There was a higher rate of infections in the rituximab group, which was largely due to SARS-CoV-2 infections despite vaccination.

IN PRACTICE:

“Rituximab was not superior to azathioprine maintenance in maintaining vasculitis remission, reducing asthma or rhinosinusitis exacerbations, or sparing glucocorticoids, and there was no signal in favor of rituximab even in patients at high risk for vasculitis relapse,” said first author of the study Xavier Puéchal, MD, PhD, of the Paris Cité University and Cochin Hospital in Paris, France.

SOURCE:

Thestudy was conducted by the French Vasculitis Study Group and was presented at the 22nd International Vasculitis Workshop (IVW) 2026 in Melbourne, Australia.

LIMITATIONS:

The researchers did not mention limitations of the trial.

DISCLOSURES:

The study was sponsored by the French Ministry of Health. Roche Pharma provided rituximab but did not have any other involvement in the study. Puéchal declared having associations with Roche, the French Ministry of Health, and other pharmaceutical companies.