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• W4212767586 abstract "BACKGROUND: Cyclophosphamide and glucocorticoids have been the cornerstone of remission-induction 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< 0.001). The rituximab-based regimen was more efficacious than the cyclophosphamide-based regimen for inducing remission of relapsing disease; 34 of 51 patients in the rituximab group (67%) as compared with 21 of 50 patients in the control group (42%) reached the primary end point (P=0.01). Rituximab was also as effective as cyclophosphamide in the treatment of patients with major renal disease or alveolar hemorrhage. There were no significant differences between the treatment groups with respect to rates of adverse events.CONCLUSIONS: Rituximab therapy was not inferior to daily cyclophosphamide treatment for induction of remission in severe ANCA-associated vasculitis and may be superior in relapsing disease. (Funded by the National Institutes of Allergy and Infectious Diseases, Genentech, and Biogen; ClinicalTrials.gov number, NCT00104299.)2010 Massachusetts Medical Society PMID: 20647199 Funding information This work was supported by: NIAMS NIH HHS, United States Grant ID: K23 AR052820-05 NCRR NIH HHS, United States Grant ID: UL1 RR024150-01 NCRR NIH HHS, United States Grant ID: UL1 RR025005-02 NCRR NIH HHS, United States Grant ID: UL1 RR025771-02 NCRR NIH HHS, United States Grant ID: UL1 RR024150 NCRR NIH HHS, United States Grant ID: RR025005 NIAMS NIH HHS, United States Grant ID: K24 AR049185 NCRR NIH HHS, United States Grant ID: M01 RR00533 NCRR NIH HHS, United States Grant ID: RR 025771 NCRR NIH HHS, United States Grant ID: M01 RR000533-38 NIAMS NIH HHS, United States Grant ID: K24 AR049185-04 NIAMS NIH HHS, United States Grant ID: K24 AR002224-05 NCRR NIH HHS, United States Grant ID: M01 RR001066 NIAMS NIH HHS, United States Grant ID: K24 AR002224 NCRR NIH HHS, United States Grant ID: UL1 RR025771 NCRR NIH HHS, United States Grant ID: M01 RR000533 NIAMS NIH HHS, United States Grant ID: K23 AR052820 NIAMS NIH HHS, United States Grant ID: U01 AR051874 NIAID NIH HHS, United States Grant ID: N01 AI015416 NCRR NIH HHS, United States Grant ID: UL1 RR025005 NIAMS NIH HHS, United States Grant ID: K24 AR02224 NIAID NIH HHS, United States Grant ID: N01AI15416 NCRR NIH HHS, United States Grant ID: RR024150-01 More Less keyboard_arrow_down" @default.
• W4212767586 created "2022-02-24" @default.
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• W4212767586 date "2011-01-05" @default.
• W4212767586 modified "2023-09-27" @default.
• W4212767586 title "Faculty Opinions recommendation of Rituximab versus cyclophosphamide for ANCA-associated vasculitis." @default.
• W4212767586 doi "https://doi.org/10.3410/f.4482956.7849060" @default.
• W4212767586 hasPublicationYear "2011" @default.
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