دورية
Sustained Remission Without Corticosteroids Among Patients With Pemphigus Who Had Rituximab as First-Line Therapy: Follow-Up of the Ritux 3 Trial
| العنوان: | Sustained Remission Without Corticosteroids Among Patients With Pemphigus Who Had Rituximab as First-Line Therapy: Follow-Up of the Ritux 3 Trial |
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| المؤلفون: | 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 |
| المصدر: | JAMA Dermatology; March 2024, Vol. 160 Issue: 3 p290-296, 7p |
| مستخلص: | 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. |
| قاعدة البيانات: | Supplemental Index |
| تدمد: | 21686068 21686084 |
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| DOI: | 10.1001/jamadermatol.2023.5679 |