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

RB. Jones, S. Furuta, JW. Tervaert, T. Hauser, R. Luqmani, MD. Morgan, CA. Peh, CO. Savage, M. Segelmark, V. Tesar, P. van Paassen, M. Walsh, K. Westman, DR. Jayne, . ,

. 2015 ; 74 (6) : 1178-82. [pub] 20150304

Language English Country England, Great Britain

Document type Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc15031440

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.

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$a Furuta, Shunsuke $u Renal Unit, Addenbrooke's Hospital, Cambridge, UK.
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$a Tervaert, Jan Willem Cohen $u Clinical and Experimental Immunology, Maastricht University, Maastricht, The Netherlands.
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$a Hauser, Thomas $u IZZ Immunologie-Zentrum Zürich, Zürich, Switzerland.
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$a Luqmani, Raashid $u Department of Rheumatology, Nuffield Orthopaedic Centre, Oxford, UK.
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$a Morgan, Matthew D $u Department of Renal Immunobiology, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
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$a Peh, Chen Au $u Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia.
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$a Savage, Caroline O $u Department of Renal Immunobiology, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
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$a Segelmark, Marten $u Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
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$a Tesar, Vladimir $u The First Faculty of Medicine, Charles University, Prague, Czech Republic.
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$a van Paassen, Pieter $u Clinical and Experimental Immunology, Maastricht University, Maastricht, The Netherlands.
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$a Walsh, Michael $u Departments of Medicine (Nephrology) and Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada.
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$a Westman, Kerstin $u Department of Nephrology and Transplantation in Malmo, University Hospital of Skane and Lund University, Malmo, Sweden.
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