A real-world pharmacovigilance study of Certolizumab pegol based on FAERS database

Certolizumab pegol (CZP), a PEGylated anti-tumor necrosis factor alpha (TNF-α) biologic, is approved for treating autoimmune disorders, including psoriatic arthritis (PsA). Despite its good therapeutic effects, its real-world safety remains limited. This study aims to evaluate the real-world safety of CZP using the FDA Adverse Event Reporting System (FAERS). We collected FAERS data from Q2 2008 to Q4 2024 related to adverse event reports associated with CZP. Four disproportionality analysis methods were used to explore the relationship between CZP and adverse events (AEs), including: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). Additionally, the study analyzed the time to onset of AEs. A total of 78,143 reports listed CZP as the primary suspect (PS), with 216,522 associated AEs. CZP-induced AEs spanned 24 system organ classes (SOCs). The median time to onset for AEs was 92 days (interquartile range: 3-409 days). At the PT level, a total of 322 AE signals were identified as positive, with known positive events including infections and infestations, general disorders, administration site conditions, and musculoskeletal and connective tissue disorders. Additionally, unexpected positive AEs, such as spontaneous abortion, premature birth, pemphigus, and basal cell carcinoma, were identified. This study systematically evaluated the safety of CZP using the FAERS database, confirming some known AEs and revealing unexpected AEs. This post-marketing safety evaluation has deepened our understanding of the safety profile of CZP, and prospective studies are needed to validate the findings of this study.