Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis

Autor: Paul A. Monach, Coen A. Stegeman, Peter A. Merkel, Nadia K. Tchao, Tobias Peikert, Eugene Y. Kissin, Vicki Seyfert-Margolis, E. William St. Clair, Linna Ding, Steven R. Ytterberg, Kathleen Mieras, David Weitzenkamp, Fernando C. Fervenza, Mark Mueller, Lourdes P. Sejismundo, Gary S. Hoffman, Ulrich Specks, Anthony M. Turkiewicz, Cees G. M. Kallenberg, John H. Stone, Robert Spiera, Nancy B. Allen, Paul Brunetta, Karina A. Keogh, Lisa Webber, Carol A. Langford, David Ikle, Duvuru Geetha, Philip Seo
Přispěvatelé: Groningen Kidney Center (GKC), Translational Immunology Groningen (TRIGR)
Jazyk: angličtina
Rok vydání: 2010
Předmět:
Zdroj: New England Journal of Medicine, 363(3), 221-232. MASSACHUSETTS MEDICAL SOC
ISSN: 0010-4299
0028-4793
Popis: Background Cyclophosphamide and glucocorticoids have been the cornerstone of remissioninduction therapy for severe antineutrophil cytoplasmic antibody (ANCA)−associated vasculitis for 40 years. Uncontrolled studies suggest that rituximab is effective and may be safer than a cyclophosphamide-based regimen. Methods We conducted a multicenter, randomized, double-blind, double-dummy, noninferiority trial of rituximab (375 mg per square meter of body-surface area per week for 4 weeks) as compared with cyclophosphamide (2 mg per kilogram of body weight per day) for remission induction. Glucocorticoids were tapered off; the primary end point was remission of disease without the use of prednisone at 6 months. Results Nine centers enrolled 197 ANCA-positive patients with either Wegener’s granulomatosis or microscopic polyangiitis. Baseline disease activity, organ involvement, and the proportion of patients with relapsing disease were similar in the two treatment groups. Sixty-three patients in the rituximab group (64%) reached the primary end point, as compared with 52 patients in the control group (53%), a result that met the criterion for noninferiority (P
Databáze: OpenAIRE