Real world pharmacovigilance study of antineoplastic drug related vitiligo risks

Vitiligo, a depigmentation disorder, significantly impacts the well-being of affected individuals. The induction of vitiligo by pharmacological agents is a critical concern, with prior research establishing a link between antineoplastic medications and the onset of vitiligo. This study aims to assess the reported association between vitiligo and antineoplastic drugs using the FAERS. The study encompassed FAERS reports spanning the years 2004 to 2024. Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of vitiligo. The Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayes Geometric Mean were calculated to assess the reported associations between available drugs and vitiligo. A significant statistical association was considered when a drug signal met the criteria of all four algorithms. Our analysis of the FAERS database revealed 533 adverse event (AE) reports implicating antineoplastic drugs in the development of vitiligo, with a higher prevalence among females compared to males. The 18-65 age group accounted for the majority of cases, with the United States contributing the most reports. Malignant melanoma was the most frequently reported underlying condition. Nivolumab and Pembrolizumab were the most commonly implicated drugs, with 147 and 126 reports, respectively. Disproportionality analysis identified 14 antineoplastic drugs with a significant association with vitiligo-related AEs, including the monoclonal antibody Mogamulizumab, immune checkpoint inhibitor Ipilimumab, and oncolytic virus Talimogene Laherparepvec, with Mogamulizumab exhibiting the highest correlation. These findings underscore the necessity for heightened clinical vigilance regarding the safety profiles of specific medications. This study represents the inaugural investigation into the real-world incidence of antineoplastic drug-induced vitiligo utilizing the FAERS database. Our findings reveal a strong association between vitiligo and immunomodulatory therapies, including immune checkpoint inhibitors and monoclonal antibodies. There is an imperative need for vigilant patient monitoring during the clinical administration of these agents to promptly identify and address potential AEs such as vitiligo.