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

医学 美罗华 内科学 不利影响 临床终点 血管炎 胃肠病学 外科 临床试验 淋巴瘤 疾病
作者
Reza Zonozi,Frank B. Cortazar,Anushya Jeyabalan,Gabriel Sauvage,Pravarut Nithagon,Noah Huizenga,Jillian Rosenthal,Alexander Sipilief,Katherine Cosgrove,Karen Laliberte,Eugene P. Rhee,William F. Pendergraft,John L. Niles
出处
期刊:Annals of the Rheumatic Diseases [BMJ]
卷期号:83 (3): 351-359 被引量:12
标识
DOI:10.1136/ard-2023-224489
摘要

Objective To compare two long-term remission maintenance strategies for antineutrophil cytoplasmic antibody (ANCA) vasculitis. Methods 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. Results 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<0.001). Conclusions Rituximab dosed for B cell repopulation results in fewer clinical relapses than when dosed for a rise in ANCA level in maintenance of remission for ANCA vasculitis. Overall safety was equivalent; SAEs due to COVID-19 and rituximab exposure were higher with the B cell strategy. Trial registration number NCT02749292 .
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