Efficacy and safety of rituximab in relapsing-remitting multiple sclerosis: A systematic review and meta-analysis

Abstract Objective This study aimed to quantitatively review and summarize the effectiveness and safety of rituximab (RTX) treatment for patients with relapsing-remitting multiple sclerosis (RRMS). Methods PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov databases were searched, and studies were screened based on inclusion and exclusion criteria. Meta-analysis was conducted with Stata. Primary outcomes included annualized relapse rate (ARR) change from baseline and relapse-free rate (RFR) at week 24, 48, 72, and 96. Secondary outcomes included Expanded Disability Status Scale (EDSS) change from baseline, the proportion of patients with infusion-related events (IRE) after treatment, and the proportion of patients with infections after treatment. Study quality assessment was performed using the Newcastle-Ottawa Scale and Cochrane Collaboration's tool. Results A total of 20 studies were included in this article and 13 of them were under quantitative synthesis. The 20 studies included 2020 patients suffering from RRMS. The overall absolute reduction in ARR of rituximab treatment in RRMS patients was 1.00 (95% confidence interval (CI) 0.83–1.17). And the overall RFRs at week 24, 48, 72, and 96 were 90.4%, 88.5%, 86.4% and 86.2%, respectively. The estimated reduction in EDSS score was 0.62 (95% CI 0.20–1.04). The overall proportion of IRE and infections were 31% and 33%, respectively. Conclusion Rituximab can improve relapse and disability conditions in patients with RRMS and has the potential for RRMS treatment. Additional evaluations on the safety of RTX is required.