Rituximab Versus Conventional Therapy for Remission Induction in Eosinophilic Granulomatosis With Polyangiitis : A Randomized Controlled Trial.
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Terrier Benjamin, Pugnet Grégory, de Moreuil Claire, Bonnotte Bernard, Benhamou Ygal, Chauveau Dominique, Besse Marie-Charlotte, Duffau Pierre, Limal Nicolas, Néel Antoine, Urbanski Geoffrey, Jourde-Chiche Noémie, Martin-Silva Nicolas, Campagne Julien, Mekinian Arsène, Schleinitz Nicolas, Ackermann Felix, Fauchais Anne-Laure, Froissart Antoine, Le Gallou Thomas, Uzunhan Yurdagul, Viallard Jean-François, Bérezné Alice, Chiche Laurent, Taillé Camille, Direz Guillaume, Durel Cécile-Audrey, Godmer Pascal, Trad Salim, Lambert Marc, de Menthon Mathilde, Quéméneur Thomas, Cadranel Jacques, Charles Pierre, Dossier Antoine, Jilet Léa, Guillevin Loïc, Abdoul Hendy, Puéchal Xavier, French Vasculitis Study Group
Аннотация
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: A total of 105 participants were randomly assigned. Thirty-three (63.5%) patients in the rituximab group achieved the primary end point compared with 32 (60.4%) in the control group (relative risk, 1.05 [95% CI, 0.78 to 1.42]; P = 0.75). Results were similar at day 360. The mean duration of remission was 48.5 ± 6.51 weeks in the rituximab group and 49.1 ± 7.42 weeks in the conventional strategy group (P = 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.