Adverse events associated with IL-23 and IL-12/23 inhibitors in the clinical management of psoriasis: a comprehensive pharmacovigilance analysis

作者：Wentao Shi, Ziyi Zhao, Yinghong Zhai, Xiaofei Ye, Xu Feng · 发表于：BMC Pharmacology and Toxicology · 年份：2025 · DOI：10.1186/s40360-025-00837-y · 被引用次数：11 · 研究领域：Psoriasis: Treatment and Pathogenesis、Pharmacovigilance and Adverse Drug Reactions、Spondyloarthritis Studies and Treatments

BACKGROUND: Interleukin-23 (IL-23) inhibitors and the IL-12/23 inhibitor ustekinumab constitute a pivotal class of therapeutic agents employed in the clinical management of Psoriasis, a chronic immune-mediated skin disorder. Notwithstanding their therapeutic efficacy, concerns have arisen due to the emergence of multiple adverse events (AEs) associated with their usage. This study aims to provide a comprehensive examination of the distribution and characteristics of these AEs concerning IL-23 and IL-12/23 inhibitors, with a specific focus on guselkumab, tildrakizumab, risankizumab, and ustekinumab. METHODS: In this research endeavor, we conducted an extensive analysis of data extracted from the FDA Adverse Event Reporting System (FAERS), spanning the timeframe from January 1, 2014, to September 30, 2022. To identify potential signals of AEs, we rigorously applied disproportionality analysis, utilizing both reporting odds ratio (ROR) and information component (IC) metrics. A signal was considered present when the lower limit of the 95% confidence interval (CI) for ROR (ROR025) exceeded one or when IC (IC025) surpassed zero, with a minimum requirement of three or more reported cases. RESULTS: Our investigation encompassed a substantial dataset, comprising a total of 41,408,408 reports detailing drug-AE associations and involving 13,271,168 individuals. Among these, 704, 13,164, and 11,399 patients were identified as users of the IL-23 inhibitors tildrakizumab, guselkumab, and r...