Fracture Risk Associated With Dimethyl Fumarate Treatment in Multiple Sclerosis Patients: Population Heterogeneity and Temporal Patterns
Abstract
Objective: Dimethyl fumarate (DMF) is currently recommended as a first-line therapy for multiple sclerosis (MS). Investigating its adverse events (AEs) holds significant clinical importance. This study aimed to explore the association between DMF and fracture-related AEs.
Methods: Data from the FDA Adverse Event Reporting System (FAERS) database (Q1 2004 to Q3 2024) were analyzed using disproportionality analysis. Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayes Geometric Mean (EBGM) were employed to identify and characterize AEs. Age- and gender-specific subgroup analyses were conducted to evaluate AE patterns. Additionally, Weibull distribution analysis was performed to assess the temporal relationship of AE onset.
Results: Overall, spinal fusion fracture (ROR = 13.13, 95% CI: 1.73-99.86) and coccyx fracture (ROR = 3.05, 95% CI: 1.92-4.86) exhibited the strongest signals. Gender and age heterogeneity were observed in DMF-associated fracture risks. Female patients showed the highest signals for spinal fusion bone fracture (ROR = 13.13) and coccyx fracture (ROR = 2.80), while males predominantly exhibited patella (ROR = 4.94) and scapula fractures (ROR = 3.68). Age stratification revealed elevated risks of forearm fracture (ROR = 10.29, 95% CI: 4.24-24.96) and ankle fracture (ROR = 5.63, 95% CI: 4.32-7.35) in elderly patients, whereas younger populations displayed diverse multi-site fractures. Time-to-onset (TTO)…
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