A retrospective pharmacovigilance study of ocrelizumab in multiple sclerosis: Analysis of the FDA Adverse Event Reporting System (FAERS) database

Ocrelizumab, a humanized anti-CD20 monoclonal antibody approved for multiple sclerosis in 2017, modulates B-cell activity to reduce disease progression. While clinical trials demonstrate its efficacy, real-world safety data remain critical to identify rare or long-term adverse events (AEs) not captured in controlled studies. This study analyzed post-marketing AEs of ocrelizumab using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) to assess safety under real-world conditions. A retrospective pharmacovigilance analysis was conducted on FAERS data from Q1 2017 to Q4 2023. Disproportionality analyses including reporting odds ratio, proportional reporting ratio, Bayesian Confidence Propagation Neural Network, and Multi-item Gamma Poisson Shrinker were used to detect safety signals. Subgroup, sensitivity, and time-to-onset analyses further characterized AE profiles. Among 50,967 reports, the analysis confirmed several AEs consistent with the ocrelizumab prescribing information, including urinary tract infection, depression, cough, herpes zoster, and breast cancer. Furthermore, potential new safety signals not previously documented in the drug's label were identified, such as alopecia, insomnia, weight increased, and sepsis. This study confirms known AEs and identifies unexpected AEs, emphasizing the need for targeted monitoring, particularly during early therapy. Real-world FAERS data complement trial findings, aiding clinicians in optimizing multiple sclerosis treatment strategies.