Safety profile of IL-23 inhibitors from the perspective of physicians and pharmacists: A retrospective real-world pharmacovigilance observational study based on the FAERS database
Chiwei Guo, Tiantian Geng, Luzhen Ye, Zhonghua Sun, Shujuan ZhaoObjective
Interleukin-23 (IL-23) inhibitors are widely used for psoriasis and inflammatory bowel disease, yet their long-term safety profiles require continual monitoring. This retrospective observational real-world study aimed to detect potential disproportionate reporting signals associated with tildrakizumab, risankizumab, and guselkumab using the FDA Adverse Event Reporting System (FAERS).
Methods
AE reports for tildrakizumab, risankizumab, and guselkumab from Q3 2017 to Q3 2025 were retrieved from FAERS. Disproportionality analysis using reporting odds ratios (RORs) was performed, and reported adverse events were classified by system organ classes (SOCs).
Results
A total of 1124, 8574, and 14597 AEs were retrieved for the three IL-23 inhibitors, generating 42, 286, and 348 disproportionate reporting signals, and accumulating 23, 24, and 24 SOCs. Frequently reported AEs included drug ineffectiveness, psoriasis, injection-site reactions, and infections. Disproportionate reporting signals not listed in the current FDA-approved product label comprised cardiovascular events (e.g., myocardial infarction; tildrakizumab ROR = 6.45), malignancies (e.g., malignant melanoma; risankizumab ROR = 8.57), hepatobiliary disorders, and renal complications.
Conclusion
These exploratory, hypothesis-generating disproportionate reporting signals may inform routine pharmacovigilance practice for IL-23 inhibitors, alongside well-established common reported events such as infections and systemic reactions. Further pharmacoepidemiologic studies are needed to validate these observations.