Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review

Area of Science:

• Neurology
• Immunology
• Pharmacovigilance

Background:

• Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
• Ocrelizumab is a targeted therapy for MS, but its safety profile requires thorough evaluation.
• Understanding adverse events (AEs) associated with ocrelizumab is crucial for patient management.

Purpose of the Study:

• To systematically review and synthesize reported adverse events (AEs) associated with ocrelizumab treatment in multiple sclerosis patients.
• To compare the incidence of specific AEs between ocrelizumab and comparator treatments (placebo or beta-interferon).
• To identify common and serious AEs to inform clinical practice and patient safety.

Main Methods:

• A comprehensive literature search was conducted across major databases (Medline, Embase, Web of Science, TOXLINE) and clinical trial registries up to July 2020.
• Included studies encompassed randomized controlled trials (RCTs), open-label trials, observational studies, and case reports evaluating ocrelizumab AEs.
• Data were analyzed to determine the frequency of AEs and compare their incidence with comparator drugs or placebo.

Main Results:

• Seventy-eight records were included, involving 4498 ocrelizumab-exposed patients.
• The most frequent AEs were infections (39.2%) and infusion-related reactions (26.2%).
• Ocrelizumab use was associated with increased risk of infections (including herpes, respiratory, nasopharyngitis, rhinitis) and infusion reactions compared to beta-interferon or placebo.

Conclusions:

• Infections and infusion-related reactions are common AEs associated with ocrelizumab in MS patients.
• While overall serious AE risk was comparable to comparators in pooled analyses, specific infection types were more frequent.
• Further research is needed to assess long-term AEs, such as malignancy, due to data limitations.