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.

Clinical and Experimental Immunology Maastricht University Maastricht The Netherlands

Department of Medical and Health Sciences Linköping University Linköping Sweden

Department of Nephrology and Transplantation in Malmo University Hospital of Skane and Lund University Malmo Sweden

Department of Renal Immunobiology School of Immunity and Infection College of Medical and Dental Sciences University of Birmingham Birmingham UK

Department of Rheumatology Nuffield Orthopaedic Centre Oxford UK

Departments of Medicine and Clinical Epidemiology and Biostatistics McMaster University Hamilton Canada

IZZ Immunologie Zentrum Zürich Zürich Switzerland

Renal Unit Addenbrooke's Hospital Cambridge UK

Royal Adelaide Hospital and University of Adelaide Adelaide Australia

The 1st Faculty of Medicine Charles University Prague Czech Republic

References provided by Crossref.org

Data quality and patient characteristics in European ANCA-associated vasculitis registries: data retrieval by federated querying

Implications of rituximab pharmacokinetic and pharmacodynamic alterations in various immune-mediated glomerulopathies and potential anti-CD20 therapy alternatives

See more in PubMed

EudraCT
2005-003610-15

ISRCTN
ISRCTN28528813