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The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.

Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis

Open access
Stone, John H., Merkel, Peter A., Spiera, Robert, Seo, Philip, Langford, Carol A., Hoffman, Gary S., Kallenberg, Cees G.M., St. Clair, E. William, Turkiewicz, Anthony, Tchao, Nadia K., Webber, Lisa, Ding, Linna, Sejismundo, Lourdes P., Mieras, Kathleen, Weitzenkamp, David, Ikle, David, Seyfert-Margolis, Vicki, Mueller, Mark, Brunetta, Paul, Allen, Nancy B., Fervenza, Fernando C., Geetha, Duvuru, Keogh, Karina A., Kissin, Eugene Y., Monach, Paul A., Peikert, Tobias, Stegeman, Coen, Ytterberg, Steven R., Specks, Ulrich·2010·New England Journal of Medicine

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.)

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Metadata

Authors
Stone, J. H., Merkel, P. A., Spiera, R., Seo, P., Langford, C. A., Hoffman, G. S., Kallenberg, C. G. M., St. Clair, E. W., Turkiewicz, A., Tchao, N. K., Webber, L., Ding, L., Sejismundo, L. P., Mieras, K., Weitzenkamp, D., Ikle, D., Seyfert-Margolis, V., Mueller, M., Brunetta, P., Allen, N. B., Fervenza, F. C., Geetha, D., Keogh, K. A., Kissin, E. Y., Monach, P. A., Peikert, T., Stegeman, C., Ytterberg, S. R., & Specks, U.
Venue
New England Journal of Medicine
Published
2010-07-15
Volume
363
Issue
3
Pages
221-232
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2063340779
Cited by
2,762
References
29
FWCI
124.95
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis. https://app.cochat.ai/papers/10.1056/nejmoa0909905
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Stone, J. H., Merkel, P. A., Spiera, R., Seo, P., Langford, C. A., Hoffman, G. S., Kallenberg, C. G. M., St. Clair, E. W., Turkiewicz, A., Tchao, N. K., Webber, L., Ding, L., Sejismundo, L. P., Mieras, K., Weitzenkamp, D., Ikle, D., Seyfert-Margolis, V., Mueller, M., Brunetta, P., . . . Specks, U. (2010). Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis. New England Journal of Medicine. https://doi.org/10.1056/nejmoa0909905

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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