Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial
2015 (English)In: Annals of the Rheumatic Diseases, ISSN 0003-4967, E-ISSN 1468-2060, Vol. 74, no 6, 1178-1182 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
BMJ Publishing Group , 2015. Vol. 74, no 6, 1178-1182 p.
B cells; Cyclophosphamide; Granulomatosis with polyangiitis; Systemic vasculitis; Treatment
IdentifiersURN: urn:nbn:se:liu:diva-119234DOI: 10.1136/annrheumdis-2014-206404ISI: 000354371200034PubMedID: 25739829OAI: oai:DiVA.org:liu-119234DiVA: diva2:821278
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 Program2015-06-152015-06-122015-06-15