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Long-Term Adverse Events of Rituximab in Multiple Sclerosis Patients, Isfahan, Iran
Ali Rahimisadegh1,2, Omid Mirmosayyeb1,2, Shakiba Houshi1,2
1Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Background:
This study's objective was to assess the adverse events (AEs) of rituximab (RTX) therapy in people with multiple sclerosis (pwMS).
Methods:
This observational study was conducted on clinical data of pwMS who visited an MS center in Iran from January 2015 to January 2018 and underwent RTX therapy. The primary efficacy outcomes assessed were disability progression and the annual relapse rate. Initially the patients received 2 g of RTX (Zytux AryoGen Pharmed Company Iran) delivered in four 500-mg doses via an intravenous line each of which took 6 hours to avoid unwanted reactions. Afterward two 500-mg doses of RTX were administered every 6 months. we administered each dose within 4-6 hours to minimize unwanted reactions.
Results:
A total of 307 RTX-treated patients were included in the study. Around 75.2% of patients were female. The mean (standard deviation (SD)) age was 37.9 (9) years, and the mean (interquartile range (IQR)) disease duration was 7 (7) years. During treatment, the Expanded Disability Status Scale (EDSS) remained unchanged for patients with shorter disease duration (<3 years), and it was significantly improved for patients with longer disease duration (>3 years, P value = 0.015). Around 39.4% of the patients had at least one side effect, most of which were minor infections of the urinary and respiratory tract, all mild in nature.
Conclusions:
RTX treatment is well-tolerated and safe, with a minor risk of mild infusion reactions and minor side effects for MS patients.
Insights
Rituximab (RTX) therapy is safe and well-tolerated for multiple sclerosis patients, with most adverse events being minor infections. This treatment showed improved disability in patients with longer disease duration.
Area of Science:
- Neurology
- Immunology
Background:
- Assessing adverse events (AEs) of rituximab (RTX) therapy in people with multiple sclerosis (pwMS).
- Observational study using clinical data from an Iranian MS center (January 2015-January 2018).
Purpose of the Study:
- Evaluate the safety and tolerability of RTX in pwMS.
- Assess RTX's impact on disability progression and relapse rates.
Main Methods:
- 307 pwMS received RTX therapy.
- Initial dose: 2g RTX (four 500mg IV doses over 6 hours).
- Maintenance: Two 500mg RTX doses every 6 months (4-6 hours per dose).
Main Results:
- 39.4% of patients experienced at least one side effect, primarily mild urinary and respiratory tract infections.
- Expanded Disability Status Scale (EDSS) remained stable for disease duration <3 years.
- Significant EDSS improvement observed in patients with disease duration >3 years (P=0.015).
Conclusions:
- Rituximab (RTX) is well-tolerated and safe for multiple sclerosis (MS) patients.
- AEs are typically minor, including mild infusion reactions and infections.
- RTX demonstrates potential for improving disability in long-standing MS.
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