Malignant melanoma and multiple sclerosis therapies: A disproportionality analysis of the FDA adverse event reporting system.

Abstract

Despite nationwide cohort studies revealing an increased risk of malignant melanoma (MM) in people with multiple sclerosis (PwMS), the connection between MS disease-modifying therapies (DMTs) and MM risk remains underexplored. We identified 1200 reports of MM associated with MS DMTs in the FDA Adverse Event Reporting System (FAERS), and a pooled analysis of all DMTs showed disproportionately high MM reporting compared to all other FAERS medications (reporting odds ratio, 2.30; 95% confidence interval, 2.16-2.45; χ², 702.33). As MS DMTs may influence MM risk, clinicians should educate PwMS on the importance of regular skin self-examinations.