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

Rachel B. Jones, Shunsuke Furuta, Jan Willem Cohen Tervaert, Thomas Hauser, Raashid Luqmani, Matthew D. Morgan, Chen Au Peh, Caroline O. Savage, Marten Segelmark, Vladimir Tesar, Pieter van Paassen, Michael Walsh, Kerstin Westman, David R. W. Jayne*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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 12months; 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 (375mg/m(2)/weekx4) with two intravenous cyclophosphamide pulses (n=33, rituximab group), or intravenous cyclophosphamide for 3-6months followed by azathioprine (n=11, control group). Results The primary end point at 24months 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 24months, 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.
Original languageEnglish
Pages (from-to)1178-1182
JournalAnnals of the Rheumatic Diseases
Volume74
Issue number6
DOIs
Publication statusPublished - Jun 2015

Keywords

  • B cells
  • Cyclophosphamide
  • Granulomatosis with polyangiitis
  • Systemic vasculitis
  • Treatment

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