• Ann. Rheum. Dis. · Jun 2015

    Randomized Controlled Trial Comparative Study

    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 Rw Jayne, and European Vasculitis Society (EUVAS).
    • Renal Unit, Addenbrooke's Hospital, Cambridge, UK.
    • Ann. Rheum. Dis. 2015 Jun 1;74(6):1178-82.

    ObjectivesThe 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.MethodsForty-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).ResultsThe 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.ConclusionsAt 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 NumberISRCTN28528813.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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