Tolerance and short-term efficacy of rituximab in 43 patients with systemic a

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Ann Rheum Dis. 2004 Dec 15; [Epub ahead of print]

 

Tolerance and short-term efficacy of rituximab in 43 patients with systemic autoimmune diseases.

Gottenberg J, Guillevin L, Lambotte O, Combe B, Allanore Y, Cantagrel A, Larroche C, Soubrier M, Bouillet L, Dougados M, Fain O, Farge D, Kyndt X, Lortholary O, Masson C, Moura B, Remy P, T, Wendling D, Anaya J, Sibilia J, Mariette X.

Hopital de Bicetre, (AP-HP), Le Kremlin-Bicetre.

OBJECTIVE: To assess the tolerance and efficacy of rituximab in patients with various autoimmune diseases seen in daily rheumatological practice. Patients and METHODS: Eight hundred and sixty-six rheumatology and internal medicine practitioners were contacted by E-mail to obtain the files of patients treated with rituximab for systemic autoimmune diseases. Patients with lymphoma were analysed if the evolution of the autoimmune disease could be evaluated. RESULTS: A total of 43 of 49 cases could be analysed in this retrospective study,including 14 patients with rheumatoid arthritis (RA), 13 with systemic lupus erythematosus (SLE), 6 with primary Sjogren's syndrome (pSS), 5 with systemic vasculitis and 5 with other autoimmune diseases. Rituximab was prescribed for lymphoma in 2 patients with RA and 2 with pSS. In the 39 other cases, rituximab was given because of the refractory character of the autoimmune disease. The mean follow-up period was 8.3 months (2-26 months). Eleven adverse events were observed in 10 patients and treatment had to be discontinued in 6 patients. The efficacy of rituximab was observed in 30 patients (70%): 11 RA, 9 SLE, 5 pSS, 2 vasculitis, 2 antisynthetase syndromes and 1 sarcoidosis. The mean decrease in daily corticosteroid intake was 9.5 mg/day (0-50) in responders. Seven patients experienced relapse after 8.1 months (5-15), on average. Three patients died because of refractory autoimmune disease. CONCLUSION: Despite the absence of marketing authorization, rituximab is used to treat various refractory autoimmune diseases in daily rheumatological practice. The present study shows good tolerance, short-term clinical efficacy and marked corticosteroid reduction with rituximab therapy in patients with RA, SLE, pSS, vasculitis or polymyositis.