Rituximab vs Azathioprine in EGPA: No Superiority in Remission Duration

Rituximab was not superior to azathioprine for prolonging remission as maintenance therapy in patients with eosinophilic granulomatosis with polyangiitis (EGPA), according to a randomized clinical trial reported in JAMA by investigators for the French Vasculitis Study Group.

According to the investigators, guidelines recommend considering maintenance therapy for patients with EGPA after remission is achieved, but data comparing maintenance options are limited.

The double-blind, double-dummy, investigator-initiated superiority trial (NCT03164473) enrolled 98 patients with newly diagnosed or relapsing EGPA at 36 hospitals in France from 2018 to 2022. Participants were within 30 to 360 days of achieving remission after standard induction. All received a standardized prednisone taper and were randomly assigned to intravenous rituximab 500mg every 6 months for 18 months or daily oral azathioprine for 24 months, each with a placebo for the other drug. Over the 28-month study period, mean time in remission while taking prednisone 7.5mg/d or less, the primary endpoint, was 91.1 weeks with rituximab and 96.0 weeks with azathioprine, a difference that was not statistically significant.

The proportion of patients who stayed in remission throughout the study at that prednisone threshold was 34.7% with rituximab and 22.4% with azathioprine, but the confidence interval included the possibility of no difference (relative risk, 1.51; 95% CI, 0.83-2.73). Vasculitis relapse occurred in 14.3% and 18.4% of patients, respectively, and clinically significant asthma or rhinosinusitis exacerbations in 32.7% and 38.8%; the abstract did not report statistical comparisons for these outcomes. Severe infections were more frequent with rituximab (46.9% vs 24.5%), mainly because of severe SARS-CoV-2 infections. One patient in the azathioprine group died of SARS-CoV-2 infection before vaccines were developed.

The investigators concluded that rituximab was not superior to azathioprine for improving the duration of total remission over 28 months while taking prednisone 7.5mg/d or less in patients with newly diagnosed or relapsing EGPA. The findings were published as a preliminary communication.

Source: Puéchal X, Pugnet G, Thoreau B, et al. Rituximab vs azathioprine for eosinophilic granulomatosis with polyangiitis maintenance therapy: a randomized clinical trial. JAMA. Published online October 22, 2026. doi:10.1001/jama.2026.15278