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|Title:||Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial|
van Paassen, P.
|Citation:||Annals of the Rheumatic Diseases, 2015; 74(6):1178-1182|
|Publisher:||BMJ Publishing Group|
|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|
|Appears in Collections:||Medicine publications|
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