Rituximab No Better Than Standard Therapy for EGPA Remission

TOPLINE:

Rituximab did not show superiority over conventional therapy in inducing remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA). Both treatment groups had similar remission rates at 180 and 360 days, with no significant differences in relapse rates or adverse events.

METHODOLOGY:

• A phase 3, multicenter, randomized, controlled superiority trial was conducted in France to compare rituximab with conventional therapy for EGPA remission induction.
• A total of 105 adult patients with active EGPA (mean age, 58.4 years; 52.4% women), defined by a Birmingham Vasculitis Activity Score (BVAS, version 3) ≥ 3, were enrolled between December 2016 and October 2019 and randomly assigned to receive either rituximab (n = 52) or conventional therapy on the basis of the five-factor score (n = 53).
• Patients in the rituximab group received 1 g of rituximab on days 1 and 15, along with glucocorticoids on a tapering schedule; those with a five-factor score ≥ 1 received placebo-cyclophosphamide and placebo-uromitexan. The conventional therapy group received glucocorticoids on a tapering schedule with or without cyclophosphamide on the basis of a five-factor score ≥ 1.
• The primary endpoint was the proportion of patients who achieved remission, defined as the absence of EGPA disease activity (indicated by a BVAS of 0 at a prednisone dose of ≤ 7.5 mg/d), at 180 days.
• Secondary endpoints included the duration of remission, glucocorticoid dose, and safety, with follow-up visits scheduled up to 360 days.

TAKEAWAY:

• At 180 days, 63.5% of patients in the rituximab group and 60.4% in the conventional group achieved remission (relative risk, 1.05; P = .75).
• At 360 days, remission rates were similar between the groups: 59.6% in the rituximab group and 64.2% in the conventional group.
• The time to remission was a median of 2 weeks in both the groups. Among patients who achieved a BVAS of 0, the mean duration of remission was comparable — 48.5 weeks for rituximab and 49.1 weeks for conventional therapy.
• No significant differences were observed in relapse rates or serious adverse event rates between the rituximab and conventional therapy groups. Infections and cardiovascular events were the most common serious adverse events.

IN PRACTICE:

“On the basis of the results of this trial, the role of rituximab in the therapeutic management of EGPA has been updated,” the authors of the study wrote. “In most of the study population with nonsevere EGPA, the lack of a clinically meaningful effect of rituximab in addition to the conventional strategy of glucocorticoids alone may appropriately inform clinical decision-making,” they added.

SOURCE:

The study was led by Benjamin Terrier, MD, PhD, Université Paris Cité in Paris, France. It was published online on July 28, 2025, in Annals of Internal Medicine.

LIMITATIONS:

The study’s design as a superiority trial may not adequately address the equivalence between rituximab and conventional therapy. The limited sample size, due to the rarity of EGPA, affected the precision of subgroup analyses. The focus on remission induction in the vasculitis phase may differ from other studies.

DISCLOSURES:

The study was funded by research grants from the French Ministry of Health and sponsored by Assistance Publique-Hôpitaux de Paris. Additional disclosures are noted in the original article online.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.