Rituximab Not Superior to Azathioprine for EGPA Maintenance

In a double-blind randomized trial of 98 patients with eosinophilic granulomatosis with polyangiitis (EGPA), rituximab did not significantly extend remission compared with azathioprine. Severe infections were more frequent with rituximab, primarily because of severe SARS-CoV-2 infections.

Rituximab did not significantly extend remission versus azathioprine.
Primary outcome: 91.1 versus 96.0 weeks in remission.
Severe infections were more frequent with rituximab.
The trial enrolled 98 participants at 36 French hospitals.

Guidelines recommend considering maintenance therapy after remission in EGPA, but comparative evidence has been limited. This investigator-initiated, double-blind, double-dummy superiority trial enrolled 98 adults at 36 hospitals in France between 2018 and 2022. Participants had newly diagnosed or relapsing EGPA and had achieved vasculitis remission after standard induction therapy. They received rituximab 500 mg intravenously every six months for 18 months or daily azathioprine for 24 months, alongside a standardized prednisone taper.

Over 28 months, mean time in remission while taking 7.5 mg/day or less of prednisone was 91.1 weeks with rituximab and 96.0 weeks with azathioprine (P=.38). The proportion remaining in remission was 34.7% and 22.4%, respectively, a difference that was not statistically significant (P=.18). Vasculitis relapse occurred in 14.3% versus 18.4%; clinically significant asthma or rhinosinusitis exacerbations occurred in 32.7% versus 38.8%.

Severe infections were reported in 46.9% of rituximab recipients and 24.5% of azathioprine recipients, primarily due to severe COVID-19. The trial found no superiority of rituximab for its primary outcome; the infection findings and study context should be considered when interpreting the comparison. Ninety-two participants completed the trial.

In practice

For patients with newly diagnosed or relapsing EGPA in remission after induction therapy, this randomized trial found no significant advantage of rituximab over azathioprine in time spent in remission while taking 7.5 mg/day or less of prednisone over 28 months. The findings do not establish that the treatments are equivalent. Severe infections were more frequent with rituximab, largely due to severe SARS-CoV-2 infections; the result should be interpreted in the context of the trial period and its 98 participants.

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Source

JAMA: Rituximab vs Azathioprine for Eosinophilic Granulomatosis With Polyangiitis Maintenance Therapy ↗

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