Rituximab was not better than azathioprine for keeping EGPA in remission, and caused more severe infections

Design

Double-blind, double-dummy, randomised superiority trial

Population

98 adults with EGPA in recent remission, 36 French hospitals

Primary outcome

Time in remission on prednisone 7.5 mg/day or less over 28 months

Effect

91.1 vs 96.0 weeks (P = 0.38); severe infections 46.9% vs 24.5%

A French double-blind, double-dummy trial randomised 98 adults with eosinophilic granulomatosis with polyangiitis (EGPA) who had recently reached remission to maintenance with rituximab 500 mg every 6 months for 18 months or daily azathioprine for 24 months, alongside a standard prednisone taper.

Mean time in remission on 7.5 mg/day of prednisone or less over 28 months was 91 weeks with rituximab and 96 weeks with azathioprine (P = 0.38). Sustained remission throughout was 35% versus 22% (RR 1.51, 95% CI 0.83–2.73), not significant. Vasculitis relapse occurred in 14% versus 18%. Severe infections were more frequent with rituximab, 47% versus 24%, mainly COVID-19 during the pandemic.

In ANCA-associated vasculitis more broadly, rituximab has displaced azathioprine for maintenance, and it has been tempting to extend that to EGPA. This trial does not support doing so routinely. Azathioprine, cheaper and oral, remains a reasonable maintenance choice in EGPA. The trial was small, and much of the infection excess fell in the pre-vaccine pandemic period.

• Azathioprine remains a reasonable maintenance choice for EGPA after remission
• Do not assume rituximab's advantage in other ANCA vasculitis carries over to EGPA
• Weigh the higher severe-infection rate when considering rituximab maintenance
• Check hepatitis B status and vaccinations before any rituximab course

Why it matters

It stops an assumption from other vasculitides being applied to EGPA.

Don't overread it

With 98 patients, the trial cannot exclude a modest benefit of rituximab, and much of the infection excess came from COVID-19 before vaccines.

The statistics, in plain English

A relative risk of 1.51 with a confidence interval of 0.83 to 2.73 means rituximab could be anywhere from somewhat worse to nearly three times better at sustaining remission; the trial was too small to tell.

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