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Type: Journal article
Title: Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial
Author: Jones, R.
Furuta, S.
Tervaert, J.
Hauser, T.
Luqmani, R.
Morgan, M.
Peh, C.
Savage, C.
Segelmark, M.
Tesar, V.
van Paassen, P.
Walsh, M.
Westman, K.
Jayne, D.
Citation: Annals of the Rheumatic Diseases, 2015; 74(6):1178-1182
Publisher: BMJ Publishing Group
Issue Date: 2015
ISSN: 1468-2060
Statement of
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,
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.
Keywords: European Vasculitis Society (EUVAS); B-Lymphocytes; Humans; Kidney Failure, Chronic; Disease Progression; Cyclophosphamide; Azathioprine; Immunosuppressive Agents; Glucocorticoids; Lymphocyte Count; Disease-Free Survival; Drug Therapy, Combination; Aged; Middle Aged; Female; Male; Renal Insufficiency, Chronic; Microscopic Polyangiitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Antibodies, Monoclonal, Murine-Derived; Granulomatosis with Polyangiitis; Rituximab
Rights: Copyright status unknown
RMID: 0030026826
DOI: 10.1136/annrheumdis-2014-206404
Appears in Collections:Medicine publications

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