Safety Assessment of Ritlecitinib Based on the FDA Adverse Event Reporting System (FAERS) Database: A Real-World Pharmacovigilance Study

Abstract

Ritlecitinib has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe alopecia areata in adults and adolescents 12 years and older, which has become a promising treatment. Given their widespread clinical use, a comprehensive real-world study of their adverse events (AEs) is warranted. This study aims to offer insights into the characteristics of ritlecitinib's association with AEs. Disproportionality metrics, including the reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean, were employed in our study. AE signals are determined by using these algorithms. The database for analysis, sourced from the FDA Adverse Event Reporting System (FAERS), covers the period from the first quarter of 2023 to the fourth quarter of 2024. A total of 12 390 AEs were identified, with 18 positive signal PTs in our study. The common AEs comprised headache (n = 39, ROR 3.22), blood creatine phosphokinase increased (n = 24, ROR 57.42), urticaria (n = 21, ROR 6.02), acne (n = 15, ROR 13.13), infection (n = 13, ROR 3.51), drug hypersensitivity (n = 13, ROR 3.49), among other AEs. Notably, five new and unexpected significant AEs that were off-label were also found, including diabetes mellitus, hair color changes, thyroid disorder, blood cholesterol abnormality, and increased lipids. Our study could provide a comprehensive safety overview of ritlecitinib during patient treatment and guide its clinical practice.