Disproportionality analysis of adverse events associated with bimekizumab: a real-world study based on FDA Adverse Event Reporting System (FAERS) Database.

Bimekizumab, a humanized monoclonal antibody targeting interleukin-17A (IL-17A) and IL-17F, is approved for the treatment of multiple chronic inflammatory conditions, including plaque psoriasis and psoriatic arthritis. Nevertheless, its long-term safety profile in large-scale patient populations has not been fully characterized. To address this gap, we conducted a pharmacovigilance analysis utilizing real-world data to systematically evaluate adverse events (AEs) associated with bimekizumab therapy. A retrospective disproportionality analysis was conducted to assess AEs associations with bimekizumab. Data spanning from the third quarter (Q3) of 2021 to the fourth quarter (Q4) of 2024 were extracted from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), a global pharmacovigilance repository. This dataset was analyzed to characterize AE profiles and time-to-onset patterns following bimekizumab administration. Among 6,037,398 AE reports documented in FAERS during the study period, 2780 cases were linked to bimekizumab. Disproportionality analysis identified 70 significant AE signals spanning 11 System Organ Classes (SOCs). Label-aligned AEs predominantly included injection site pain, oral candidiasis, and esophageal candidiasis. Additionally, 29 off-label safety signals emerged, encompassing cellulitis, lower respiratory tract infections, Staphylococcus infections, immunodeficiency, and Mycoplasma pneumonia. The median time-to-onset for bimekizumab-related AEs was 29 days (interquartile range [IQR]: 0-84.75 days). This pharmacovigilance study corroborates established safety profiles of bimekizumab while uncovering previously unreported AE signals. These findings underscore the need for vigilant post-marketing surveillance to refine risk-benefit assessments in clinical practice.