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Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial
Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial
- Publication Year :
- 2015
-
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 12months; 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 (375mg/m(2)/weekx4) with two intravenous cyclophosphamide pulses (n=33, rituximab group), or intravenous cyclophosphamide for 3-6months followed by azathioprine (n=11, control group). Results The primary end point at 24months 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 24months, 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.<br />Funding Agencies|Cambridge University Hospitals National Health Service Foundation Trust; Cambridge Biomedical Research Centre; F Hoffmann-La Roche; New Investigator award from the Kidney Research Scientist Core Education and National Training Program
Details
- Database :
- OAIster
- Notes :
- English
- Publication Type :
- Electronic Resource
- Accession number :
- edsoai.on1234086983
- Document Type :
- Electronic Resource
- Full Text :
- https://doi.org/10.1136.annrheumdis-2014-206404