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Background The combination of multiple cycles of rituximab and intravenous immune globulins has been reported to be effective in patients with severe pemphigus. The aim of this study was to assess the efficacy of a single cycle of rituximab in severe types of pemphigus.
Methods We studied 21 patients with pemphigus whose disease had not responded to an 8-week course of 1.5 mg of prednisone per kilogram of body weight per day (corticosteroid-refractory disease), who had had at least two relapses despite doses of prednisone higher than 20 mg per day (corticosteroid-dependent disease), or who had severe contraindications to corticosteroids. The patients were treated with four weekly infusions of 375 mg of rituximab per square meter of body-surface area. The primary end point was complete remission 3 months after the end of rituximab treatment; complete remission was defined as epithelialization of all skin and mucosal lesions.
Results Eighteen of 21 patients (86%; 95% confidence interval, 64 to 97%) had a complete remission at 3 months. The disease relapsed in nine patients after a mean of 18.9±7.9 months. After a median follow-up of 34 months, 18 patients (86%) were free of disease, including 8 who were not receiving corticosteroids; the mean prednisone dose decreased from 94.0±10.2 to 12.0±7.5 mg per day (P=0.04) in patients with corticosteroid-refractory disease and from 29.1±12.4 to 10.9±16.5 mg per day (P=0.007) in patients with corticosteroid-dependent disease. Pyelonephritis developed in one patient 12 months after rituximab treatment, and one patient died of septicemia 18 months after rituximab treatment. These patients had a profound decrease in the number of circulating B lymphocytes but normal serum levels of IgG.
Conclusions A single cycle of rituximab is an effective treatment for pemphigus. Because of its potentially severe side effects, its use should be limited to the most severe types of the disease. (ClinicalTrials.gov number, NCT00213512
[ClinicalTrials.gov]
.)
Source Information
From Rouen University Hospital, Rouen (P.J., P.M.); INSERM Unité 519, Rouen University Hospital, Rouen (P.J., H.M., D.G., S.J., F.T., P.M.); Henri Mondor University Hospital, Créteil (J.-C.R.); Clermont-Ferrand University Hospital, Clermont-Ferrand (M.D.); Pasteur Institute, Paris (M.-L.G.); Limoges University Hospital, Limoges (C.B.); Nantes University Hospital, Nantes (B.D.); Bordeaux University Hospital, Bordeaux (M.-S.D.); Lille University Hospital, Lille (E.D.); Poissy–Saint Germain-en-Laye Intercommunal Hospital, Saint Germain-en-Laye (C. Pauwels); Paris V University, Paris (N.F.); Paris XIII University Hospital, Bobigny (F.C.); Bichat University Hospital, Paris (C. Picard); Paris X University Hospital, Paris (E.T.-B.); and Reims University Hospital, Reims (P.B.) — all in France; and the Faculty of Medicine, Philipp University, Marburg, Germany (R.M., M.H.).
Address reprint requests to Dr. Joly at the Clinique Dermatologique, Hôpital Charles Nicolle, 1 rue de Germont, 76031 Rouen CEDEX, France, or at Pascal.Joly{at}chu-rouen.fr.
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