Rituximab in Eosinophilic Granulomatosis With Polyangiitis

Summary

Phase III, comparative, multicenter, randomized, controlled, double-blind and superiority research, comparing rituximab-based regimen with conventional therapeutic strategy for the induction of remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA). Patients with newly diagnosed or relapsing EGPA will be randomized in a 1:1 ratio to receive: * Experimental therapeutic strategy based on the use of rituximab (experimental group) * Conventional therapeutic strategy based on Five-Factor Score (FFS)-assessed disease severity (comparative group)

Timeline

Start

2016-12-05

Primary completion

2020-10-21

Completion

2020-10-21

Outcome

Missed primary endpoint

paper relative risk, 1.05 [95% CI, 0.78 to 1.42]; P = 0.75 PMID 40720835 ↗

paper Rituximab was not superior to a conventional remission induction strategy in EGPA. PMID 40720835 ↗

Publications

• Results Terrier B, Pugnet G, de Moreuil C, Bonnotte B, Benhamou Y, Chauveau D, Besse MC, Duffau P, Limal N, Neel A, Urbanski G, Jourde-Chiche N, Martin-Silva N, Campagne J, Mekinian A, Schleinitz N, Ackermann F, Fauchais AL, Froissart A, Le Gallou T, Uzunhan Y, Viallard JF, Berezne A, Chiche L, Taille C, Direz G, Durel CA, Godmer P, Trad S, Lambert M, de Menthon M, Quemeneur T, Cadranel J, Charles P, Dossier A, Jilet L, Guillevin L, Abdoul H, Puechal X; French Vasculitis Study Group. Rituximab Versus Conventional Therapy for Remission Induction in Eosinophilic Granulomatosis With Polyangiitis : A Randomized Controlled Trial. Ann Intern Med. 2025 Sep;178(9):1249-1257. doi: 10.7326/ANNALS-24-03947. Epub 2025 Jul 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclophosphamide	Other / unclassified	500 mg	Intravenous
Subject	Rituximab	Monoclonal antibody	1 g	Intravenous

Indications