Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial

Research output: Contribution to journalArticle

Authors

  • Rachel B Jones
  • Shunsuke Furuta
  • Jan Willem Cohen Tervaert
  • Thomas Hauser
  • Raashid Luqmani
  • Matthew Morgan
  • Chen Au Peh
  • Caroline Savage
  • Marten Segelmark
  • Vladimir Tesar
  • Pieter van Paassen
  • Michael Walsh
  • Kerstin Westman
  • David Rw Jayne
  • European Vasculitis Society (EUVAS)

Colleges, School and Institutes

Abstract

OBJECTIVES: The RITUXVAS trial reported similar remission induction rates and safety between rituximab and cyclophosphamide based regimens for antineutrophil cytoplasm antibody (ANCA)-associated vasculitis at 12 months; however, immunosuppression maintenance requirements and longer-term outcomes after rituximab in ANCA-associated renal vasculitis are unknown.

METHODS: Forty-four patients with newly diagnosed ANCA-associated vasculitis and renal involvement were randomised, 3:1, to glucocorticoids plus either rituximab (375 mg/m(2)/week×4) with two intravenous cyclophosphamide pulses (n=33, rituximab group), or intravenous cyclophosphamide for 3-6 months followed by azathioprine (n=11, control group).

RESULTS: The primary end point at 24 months was a composite of death, end-stage renal disease and relapse, which occurred in 14/33 in the rituximab group (42%) and 4/11 in the control group (36%) (p=1.00). After remission induction treatment all patients in the rituximab group achieved complete B cell depletion and during subsequent follow-up, 23/33 (70%) had B cell return. Relapses occurred in seven in the rituximab group (21%) and two in the control group (18%) (p=1.00). All relapses in the rituximab group occurred after B cell return.

CONCLUSIONS: At 24 months, rates of the composite outcome of death, end-stage renal disease and relapse did not differ between groups. In the rituximab group, B cell return was associated with relapse.

TRIAL REGISTRATION NUMBER: ISRCTN28528813.

Details

Original languageEnglish
Pages (from-to)1178-82
Number of pages5
JournalAnnals of the Rheumatic Diseases
Volume74
Issue number6
Early online date4 Mar 2015
Publication statusPublished - Jun 2015

Keywords

  • Aged, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antibodies, Monoclonal, Murine-Derived, Azathioprine, B-Lymphocytes, Cyclophosphamide, Disease Progression, Disease-Free Survival, Drug Therapy, Combination, Female, Glucocorticoids, Granulomatosis with Polyangiitis, Humans, Immunosuppressive Agents, Kidney Failure, Chronic, Lymphocyte Count, Male, Microscopic Polyangiitis, Middle Aged, Renal Insufficiency, Chronic