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Efficacy of remission-induction regimens for ANCA-associated vasculitis.

Publication ,  Journal Article
Specks, U; Merkel, PA; Seo, P; Spiera, R; Langford, CA; Hoffman, GS; Kallenberg, CGM; St Clair, EW; Fessler, BJ; Ding, L; Viviano, L; Lim, N ...
Published in: N Engl J Med
August 1, 2013

BACKGROUND: The 18-month efficacy of a single course of rituximab as compared with conventional immunosuppression with cyclophosphamide followed by azathioprine in patients with severe (organ-threatening) antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis is unknown. METHODS: In a multicenter, randomized, double-blind, double-dummy, noninferiority trial, we compared rituximab (375 mg per square meter of body-surface area administered once a week for 4 weeks) followed by placebo with cyclophosphamide administered for 3 to 6 months followed by azathioprine for 12 to 15 months. The primary outcome measure was complete remission of disease by 6 months, with the remission maintained through 18 months. RESULTS: A total of 197 patients were enrolled. As reported previously, 64% of the patients in the rituximab group, as compared with 53% of the patients in the cyclophosphamide-azathioprine group, had a complete remission by 6 months. At 12 and 18 months, 48% and 39%, respectively, of the patients in the rituximab group had maintained the complete remissions, as compared with 39% and 33%, respectively, in the comparison group. Rituximab met the prespecified criteria for noninferiority (P<0.001, with a noninferiority margin of 20%). There was no significant difference between the groups in any efficacy measure, including the duration of complete remission and the frequency or severity of relapses. Among the 101 patients who had relapsing disease at baseline, rituximab was superior to conventional immunosuppression at 6 months (P=0.01) and at 12 months (P=0.009) but not at 18 months (P=0.06), at which time most patients in the rituximab group had reconstituted B cells. There was no significant between-group difference in adverse events. CONCLUSIONS: In patients with severe ANCA-associated vasculitis, a single course of rituximab was as effective as continuous conventional immunosuppressive therapy for the induction and maintenance of remissions over the course of 18 months. (Funded by the National Institute of Allergy and Infectious Diseases and others; RAVE ClinicalTrials.gov number, NCT00104299.)

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 1, 2013

Volume

369

Issue

5

Start / End Page

417 / 427

Location

United States

Related Subject Headings

  • Rituximab
  • Remission Induction
  • Recurrence
  • Kaplan-Meier Estimate
  • Immunosuppressive Agents
  • Immunologic Factors
  • Humans
  • Glucocorticoids
  • General & Internal Medicine
  • Drug Therapy, Combination
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Specks, U., Merkel, P. A., Seo, P., Spiera, R., Langford, C. A., Hoffman, G. S., … RAVE-ITN Research Group, . (2013). Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med, 369(5), 417–427. https://doi.org/10.1056/NEJMoa1213277
Specks, Ulrich, Peter A. Merkel, Philip Seo, Robert Spiera, Carol A. Langford, Gary S. Hoffman, Cees G. M. Kallenberg, et al. “Efficacy of remission-induction regimens for ANCA-associated vasculitis.N Engl J Med 369, no. 5 (August 1, 2013): 417–27. https://doi.org/10.1056/NEJMoa1213277.
Specks U, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, et al. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013 Aug 1;369(5):417–27.
Specks, Ulrich, et al. “Efficacy of remission-induction regimens for ANCA-associated vasculitis.N Engl J Med, vol. 369, no. 5, Aug. 2013, pp. 417–27. Pubmed, doi:10.1056/NEJMoa1213277.
Specks U, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CGM, St Clair EW, Fessler BJ, Ding L, Viviano L, Tchao NK, Phippard DJ, Asare AL, Lim N, Ikle D, Jepson B, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh K, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Mueller M, Sejismundo LP, Mieras K, Stone JH, RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013 Aug 1;369(5):417–427.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 1, 2013

Volume

369

Issue

5

Start / End Page

417 / 427

Location

United States

Related Subject Headings

  • Rituximab
  • Remission Induction
  • Recurrence
  • Kaplan-Meier Estimate
  • Immunosuppressive Agents
  • Immunologic Factors
  • Humans
  • Glucocorticoids
  • General & Internal Medicine
  • Drug Therapy, Combination