Maintenance of remission of ANCA vasculitis by rituximab based on B cell repopulation versus serological flare: a randomised trial.

Publication date: Feb 15, 2024

To compare two long-term remission maintenance strategies for antineutrophil cytoplasmic antibody (ANCA) vasculitis. We conducted a prospective, single-centre, open-label, randomised controlled trial of patients with ANCA vasculitis in remission after completing at least 2 years of fixed-schedule rituximab. In the B cell arm, rituximab was reinfused upon B cell repopulation; in the ANCA arm, rituximab was reinfused upon significant rise in ANCA level. Evaluations were conducted every 3 months. The primary endpoint was clinical relapse, defined as a modified BVAS/WG >0 by 36 months. Secondary endpoints included serious adverse events (SAEs) and rituximab exposure. 115 patients were enrolled. Median follow-up time was 4. 1 years (IQR 2. 5-5. 0). By Kaplan-Meier analysis, 4. 1% (95% CI 1. 0 to 15. 6) of patients had a clinical relapse in the B cell arm, compared with 20. 5% (95% CI 11. 9 to 34. 1) in the ANCA arm, at 3 years after study entry (log-rank p=0. 045). Total SAEs, including infectious SAEs, and deaths did not differ. The number of SAEs due to COVID-19 was higher in the B cell arm (p=0. 049). In the B cell arm, patients received a mean of 3. 6 (SD 2. 4) infusions (3. 6 g) per person over the median study follow-up time of 4. 1 years, compared with 0. 5 (SD 1. 4) infusions (0. 5 g) per patient in the ANCA arm (p

Concepts Keywords
2years Autoantibodies
Deaths B-Lymphocytes
Infectious Rituximab
Rituximab Systemic vasculitis


Type Source Name
disease MESH vasculitis
drug DRUGBANK Rituximab
disease IDO cell
disease VO time
disease MESH COVID-19
disease MESH Systemic vasculitis

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