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

ABSTRACT: 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 t

SUBMITTER: Liu M 

PROVIDER: S-EPMC12325714 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature