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Tedbirt, Billal; Maho-Vaillant, Maud; Houivet, Estelle; Mignard, Claire; Golinski, Marie-Laure; Calbo, Sébastien; Prost-Squarcioni, Catherine; Labeille, Bruno; Picard-Dahan, Catherine; Chaby, Guillaume; Richard, Marie-Aleth; Tancrede-Bohin, Emmanuelle; Duvert-Lehembre, Sophie; Delaporte, Emmanuel; Bernard, Philippe; Caux, Frédéric; Alexandre, Marina; Musette, Philippe; Ingen-Housz-Oro, Saskia; Vabres, Pierre; Quereux, Gaëlle; Dupuy, Alain; Debarbieux, Sébastien; Avenel-Audran, Martine; D’Incan, Michel; Bédane, Christophe; Bénéton, Nathalie; Jullien, Denis; Dupin, Nicolas; Misery, Laurent; Machet, Laurent; Beylot-Barry, Marie; Dereure, Olivier; Sassolas, Bruno; Benichou, Jacques; Joly, Pascal; Hébert, Vivien
JAMA dermatology (Chicago, Ill.), 2024-Mar-01, Volume: 160, Issue: 3Journal Article
IMPORTANCE: The Ritux 3 trial demonstrated the short-term efficacy and safety of first-line treatment with rituximab compared with a standard corticosteroid regimen in pemphigus. No data on the long-term follow-up of patients who received rituximab as first line are available. OBJECTIVE: To assess the long-term efficacy and safety of the Ritux 3 treatment regimen. DESIGN, SETTING, AND PARTICIPANTS: This 7-year follow-up study of the Ritux 3 trial included patients with pemphigus from 25 dermatology departments in France from January 1, 2010, to December 31, 2015. EXPOSURE: Patients were initially randomized in the rituximab plus prednisone group or prednisone-alone group. MAIN OUTCOMES AND MEASURES: The primary outcome was the 5- and 7-year disease-free survival (DFS) without corticosteroids, assessed by Kaplan-Meier curves. Secondary outcomes were occurrence of relapse, occurrence of severe adverse events (SAEs), and evolution of antidesmoglein (Dsg) antibody enzyme-linked immunosorbent assay values to predict long-term relapse. RESULTS: Of the 90 patients in the Ritux 3 trial, 83 were evaluated at the end of follow-up study visit (44 in the rituximab plus prednisone group; 39 in the prednisone-alone group) with a median (IQR) follow-up of 87.3 (79.1-97.5) months. Forty-three patients (93%) from the rituximab plus prednisone and 17 patients (39%) from the prednisone-alone group had achieved complete remission without corticosteroids at any time during the follow-up. Patients from the rituximab group had much longer 5- and 7-year DFS without corticosteroids than patients from the prednisone-alone group (76.7% and 72.1% vs 35.3% and 35.3%, respectively; P < .001), and had about half the relapses (42.2% vs 83.7%; P < .001). Patients who received rituximab as second-line treatment had shorter DFS than patients treated as first line (P = .007). Fewer SAEs were reported in the rituximab plus prednisone group compared with the prednisone-alone group, 31 vs 58 respectively, corresponding to 0.67 and 1.32 SAEs per patient, respectively (P = .003). The combination of anti-Dsg1 values of 20 or more IU/mL and/or anti-Dsg3 values of 48 or more IU/mL yielded 0.83 positive predictive value and 0.94 negative predictive value to predict long-term relapse. CONCLUSIONS AND RELEVANCE: In this secondary analysis of the Ritux 3 trail, first-line treatment of patients with pemphigus with the Ritux 3 regimen was associated with long-term sustained complete remission without corticosteroid therapy without any additional maintenance infusion of rituximab.
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