35171 Malignant melanoma cases associated with IL-23 inhibitors: Pharmacovigilance analysis of real-world evidence in the Food and Drug Administration Adverse Event Reporting System (FAERS) from the RADAR (Research on Adverse Drug events And Reports) program

Abstract

Background: IL-23 effects on tumorigenesis is suggestive, but remains unknown. The aim of this study was to determine if a safety signal is detectable for IL-23 inhibitor exposure and malignant melanoma in the FAERS database. Methods: Using MedDra terms for malignant melanoma, the FAERS database (for each FDA product approval date through Q4 2020) was analyzed using Proportional Reporting Ratio (PRR) for detection of a safety signal after exposure to risankizumab, guselkumab or tildrakizumab individually and as a class of drugs. PRR is defined as number of events >3, χ2 > 4 and PRR > 2. Results: A safety signal was detected for IL-23 inhibitors as a class (N = 17; PRR: 3.52; 95% CI 2.19-5.66) as well as for risankizumab (N = 9; PRR: 9.11; 95% CI 4.75-17.45), but not for guselkumab (N = 8; PRR: 2.17; 95% CI 1.09-4.35) or tidrakizumab (no cases). Conclusion Based on the findings from this real-world evidence, there is an increased risk for melanoma subsequent to exposure to an IL-23 inhibitor. Further evidence from large patient populations is warranted to better define this serious new risk.