Rituximab Versus Conventional Therapy for Remission Induction in Eosinophilic Granulomatosis With Polyangiitis
Benjamin Terrier, G. Pugnet, Claire de Moreuil, Bernard Bonnotte, Y. Benhamou, Dominique Chauveau, Marie-Charlotte Besse, P. Duffau, Nicolas Limal, A. Néel, G. Urbanski, Noémie Jourde‐Chiche, Nicolas Martin-Silva, Julien Campagne, A. Mékinian, N. Schleinitz, Félix Ackermann, A.L. Fauchais, Antoine Froissart, Thomas Le Gallou, Y. Uzunhan, Jean‐François Viallard, A. Bérezné, Laurent Chiche, Camille Taillé, Guillaume Direz, Cécile‐Audrey Durel, Pascal Godmer, S. Trad, M. Lambert, Mathilde de Menthon, Thomas Quéméneur, J. Cadranel, Pierre Charles, Antoine Dossier, Léa Jilet, Loı̈c Guillevin, Hendy Abdoul, Xavier Puéchal, French Vasculitis Study Group, Benjamin Terrier, Grégory Pugnet, Claire de Moreuil, Bernard Bonnotte, Ygal Benhamou, Dominique Chauveau, Marie-Charlotte Besse, P. Duffau, Nicolas Limal, A. Néel, G. Urbanski, Noémie Jourde-Chiche, Nicolas Martin-Silva, Julien Campagne, Arsène Mekinian, N. Schleinitz, Félix Ackermann, A.L. Fauchais, Antoine Froissart, Thomas Le Gallou, Y. Uzunhan, Jean‐François Viallard, Alice Bérezné, Laurent Chiche, Camille Taillé, Guillaume Direz, Cécile‐Audrey Durel, Pascal Godmer, S. Trad, M. Lambert, Mathilde de Menthon, Thomas Quéméneur, J. Cadranel, Pierre Charles, Antoine Dossier, Léa Jilet, Loı̈c Guillevin, Hendy Abdoul, Xavier Puéchal
Abstract
BACKGROUND: Eosinophilic granulomatosis with polyangiitis (EGPA) is an eosinophilic antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Rituximab has emerged as the standard of care in other types of ANCA-associated vasculitis, but controlled studies on its use in EGPA are yet lacking. OBJECTIVE: To compare rituximab with conventional strategy for the induction of remission in patients with EGPA. DESIGN: Phase 3, multicenter, randomized, controlled, double-blind, superiority trial. (ClinicalTrials.gov: NCT02807103). SETTING: France. PARTICIPANTS: Patients with a diagnosis of EGPA, newly diagnosed or relapsing disease at the time of screening, with active disease defined as a Birmingham Vasculitis Activity Score (BVAS) of 3 or greater. INTERVENTION: Glucocorticoids plus rituximab (1 g 2 weeks apart) compared with the conventional strategy (glucocorticoids alone or in combination with cyclophosphamide in severe forms) for induction of remission. MEASUREMENTS: The primary end point was remission defined as a BVAS, version 3, of 0 and a prednisone dose of 7.5 mg/d or less at day 180. Secondary end points included duration of remission during the study, average daily glucocorticoid dose, and safety. RESULTS: = 0.41). All relapse and major relapse rates were similar between the 2 groups. There was no statistically significant difference in the average daily glucocorticoid dose and no statistically significant differences in the rates of adverse events between the treatment groups. LIMITATION: Design not appropriate to answer the question of equivalence between rituximab and cyclophosphamide in patients with severe EGPA. CONCLUSIONS: Rituximab was not superior to a conventional remission induction strategy in EGPA. PRIMARY FUNDING SOURCE: French Ministry of Health.