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Ann Rheum Dis. 2015 Jun;74(6):1178-82. doi: 10.1136/annrheumdis-2014-206404. Epub 2015 Mar 4.

Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial.

Author information

1
Renal Unit, Addenbrooke's Hospital, Cambridge, UK.
2
Clinical and Experimental Immunology, Maastricht University, Maastricht, The Netherlands.
3
IZZ Immunologie-Zentrum Zürich, Zürich, Switzerland.
4
Department of Rheumatology, Nuffield Orthopaedic Centre, Oxford, UK.
5
Department of Renal Immunobiology, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
6
Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia.
7
Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
8
The First Faculty of Medicine, Charles University, Prague, Czech Republic.
9
Departments of Medicine (Nephrology) and Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada.
10
Department of Nephrology and Transplantation in Malmo, University Hospital of Skane and Lund University, Malmo, Sweden.

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/m(2)/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.

TRIAL REGISTRATION NUMBER:

ISRCTN28528813.

KEYWORDS:

B cells; Cyclophosphamide; Granulomatosis with polyangiitis; Systemic vasculitis; Treatment

PMID:
25739829
DOI:
10.1136/annrheumdis-2014-206404
[Indexed for MEDLINE]

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