What question did this study set out to answer?

This study aims to evaluate the real-world effectiveness and safety of rituximab in treating multiple sclerosis in Brazil.

May 20, 2026Arquivos de Neuro-Psiquiatria0 citationsOpen Access

Real-world experience with rituximab for multiple sclerosis treatment in a Brazilian tertiary center

ASAna Beatriz Simon-Nogueira AHArthur Cesário de Holanda RRRafael Augusto Rosalem

Key Points

This study aims to evaluate the real-world effectiveness and safety of rituximab in treating multiple sclerosis in Brazil.
Single-center observational study at a tertiary center, including 45 multiple sclerosis patients treated with rituximab from January 2016 to October 2024.
Primary outcome: change in annualized relapse rate after rituximab initiation; secondary outcomes included disability progression, radiological activity, and safety.
Statistical analyses utilized non-parametric tests and time-to-event analysis.
Rituximab reduced the annualized relapse rate by 89.8% (from 0.49 to 0.05; p<0.001), with 90.9% of patients remaining relapse-free.
In relapsing-remitting MS patients, the annualized relapse rate decreased from 0.56 to 0.17 (p=0.019), with 88% remaining relapse-free (95%CI: 68.8–97.5).
Infusion-related reactions occurred in 12 patients (26.7%), while infections, the most common non-infusion adverse event, were reported in 20 patients (57.8%).

Abstract

Abstract Rituximab, an anti-cluster of differentiation 20 (anti-CD20) monoclonal antibody, has been widely used off-label for multiple sclerosis (MS) treatment, demonstrating high effectiveness and a favorable safety profile. However, real-world data from Brazil, particularly within the public healthcare system, remain scarce. To assess the real-world effectiveness and safety of rituximab for MS treatment in a Brazilian tertiary center. We conducted a single-center, observational study at Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), including MS patients treated with rituximab between January 2016 and October 2024. The primary outcome was the change in annualized relapse rate (ARR) following rituximab initiation. The secondary outcomes included disability progression, radiological activity, and safety. The statistical analyses employed non-parametric tests and time-to-event analysis. Among the 45 patients (25 with relapsing-remitting MS RRMS, 18 with secondary progressive MS, and 2 with primary progressive MS), rituximab reduced the ARR by 89.8% (from 0.49–0.05; p < 0.001), with 90.9% remaining relapse-free. In RRMS patients, the ARR significantly decreased, from 0.56 to 0.17, after rituximab initiation (p = 0.019), with 88% remaining relapse-free (95%CI: 68.8–97.5). Radiological activity was observed in 6.8% of the sample. Patients with breakthrough disease activity (n = 4; 8.9%) presented more frequent prior natalizumab use than those without it (75.0% versus 43.9%; p = 0.039), as well as higher pretreatment relapse rates (1.8 versus 0.7; p = 0.033). Infusion-related reactions affected 12 (26.7%) patients, and they were mostly mild, while infections were the most common non-infusion adverse event (20; 57.8%). In total, 4 patients discontinued rituximab, mainly due to access limitations. Rituximab demonstrated high effectiveness and acceptable safety for MS treatment in a Brazilian public healthcare setting. Its favorable risk-benefit profile supports broader adoption in resource-limited contexts.

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