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Rituximab versus cyclophosphamide for ANCA-associated vasculitis.

Publication ,  Journal Article
Stone, JH; Merkel, PA; Spiera, R; Seo, P; Langford, CA; Hoffman, GS; Kallenberg, CGM; St Clair, EW; Turkiewicz, A; Tchao, NK; Webber, L ...
Published in: N Engl J Med
July 15, 2010

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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 15, 2010

Volume

363

Issue

3

Start / End Page

221 / 232

Location

United States

Related Subject Headings

  • Rituximab
  • Remission Induction
  • Quality of Life
  • Prednisone
  • Neoplasms
  • Middle Aged
  • Microscopic Polyangiitis
  • Methylprednisolone
  • Male
  • Intention to Treat Analysis
 

Citation

APA
Chicago
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MLA
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Stone, J. H., Merkel, P. A., Spiera, R., Seo, P., Langford, C. A., Hoffman, G. S., … RAVE-ITN Research Group, . (2010). Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med, 363(3), 221–232. https://doi.org/10.1056/NEJMoa0909905
Stone, John H., Peter A. Merkel, Robert Spiera, Philip Seo, Carol A. Langford, Gary S. Hoffman, Cees G. M. Kallenberg, et al. “Rituximab versus cyclophosphamide for ANCA-associated vasculitis.N Engl J Med 363, no. 3 (July 15, 2010): 221–32. https://doi.org/10.1056/NEJMoa0909905.
Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221–32.
Stone, John H., et al. “Rituximab versus cyclophosphamide for ANCA-associated vasculitis.N Engl J Med, vol. 363, no. 3, July 2010, pp. 221–32. Pubmed, doi:10.1056/NEJMoa0909905.
Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CGM, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U, RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221–232.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 15, 2010

Volume

363

Issue

3

Start / End Page

221 / 232

Location

United States

Related Subject Headings

  • Rituximab
  • Remission Induction
  • Quality of Life
  • Prednisone
  • Neoplasms
  • Middle Aged
  • Microscopic Polyangiitis
  • Methylprednisolone
  • Male
  • Intention to Treat Analysis