A real-world pharmacovigilance study of Ocrelizumab based on FAERS database

Abstract Ocrelizumab is a humanized monoclonal antibody targeting CD20 for the treatment of multiple sclerosis (MS). The analysis of the FDA Adverse Event Reporting System database (FAERS) provides critical insights into the safety profile of Ocrelizumab. Signal detection and analysis for Ocrelizumab-related AEs were performed using disproportionality analysis techniques. Of 30622295 reports collected from the FAERS database, 143788 AE reports associated with Ocrelizumab were identified, involving 42301 patients. Among these reports, 427 preferred terms (PTs) met the criteria across four algorithms for signal detection, encompassing a total of 27 System Organ Classes (SOCs). The most frequently reported AEs included respiratory infections, urinary tract infections, Herpes virus infection, and infusion-related reactions, aligning with those documented in the drug label and clinical trials. Novel and unexpected AE signals were also detected, such as COVID-19, positive JC polyomavirus test, dental disease, cystitis, cellulitis, etc., with most adverse reactions occurring within the first month of dosing. Our study indicates that Ocrelizumab demonstrates a favorable safety profile, consistent with findings from existing clinical trials. This study has identified the adverse reactions associated with Ocrelizumab, providing valuable insights for its clinical use.