Back to Search Start Over

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

Authors :
Jones, Rachel B.
Furuta, Shunsuke
Cohen Tervaert, Jan Willem
Hauser, Thomas
Luqmani, Raashid
Morgan, Matthew D.
Au Peh, Chen
Savage, Caroline O.
Segelmark, Mårten
Tesar, Vladimir
van Paassen, Pieter
Walsh, Michael
Westman, Kerstin
Jayne, David R. W.
Jones, Rachel B.
Furuta, Shunsuke
Cohen Tervaert, Jan Willem
Hauser, Thomas
Luqmani, Raashid
Morgan, Matthew D.
Au Peh, Chen
Savage, Caroline O.
Segelmark, Mårten
Tesar, Vladimir
van Paassen, Pieter
Walsh, Michael
Westman, Kerstin
Jayne, David R. W.
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