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Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial
  1. Rachel B Jones1,
  2. Shunsuke Furuta1,
  3. Jan Willem Cohen Tervaert2,
  4. Thomas Hauser3,
  5. Raashid Luqmani4,
  6. Matthew D Morgan5,
  7. Chen Au Peh6,
  8. Caroline O Savage5,
  9. Marten Segelmark7,
  10. Vladimir Tesar8,
  11. Pieter van Paassen2,
  12. Michael Walsh9,
  13. Kerstin Westman10,
  14. David RW Jayne1,
  15. for the European Vasculitis Society (EUVAS)
  1. 1Renal Unit, Addenbrooke's Hospital, Cambridge, UK
  2. 2Clinical and Experimental Immunology, Maastricht University, Maastricht, The Netherlands
  3. 3IZZ Immunologie-Zentrum Zürich, Zürich, Switzerland
  4. 4Department of Rheumatology, Nuffield Orthopaedic Centre, Oxford, UK
  5. 5Department of Renal Immunobiology, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  6. 6Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia
  7. 7Department of Medical and Health Sciences, Linköping University, Linköping, Sweden
  8. 8The First Faculty of Medicine, Charles University, Prague, Czech Republic
  9. 9Departments of Medicine (Nephrology) and Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada
  10. 10Department of Nephrology and Transplantation in Malmo, University Hospital of Skane and Lund University, Malmo, Sweden
  1. Correspondence to Dr David Jayne, Lupus and Vasculitis Clinic, Box 57, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK; dj106{at}cam.ac.uk

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/m2/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.

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

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