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Fracture Risk Associated With Dimethyl Fumarate Treatment in Multiple Sclerosis Patients: Population Heterogeneity
Dongdong He1, Jingkai Di1,2, Peirui Jiang3
1Department of Orthopedics, Second Hospital of Shanxi Medical University, Taiyuan, China.
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) analysis indicated that 63.62% of fractures occurred within the first 2 years of the treatment cycle, with a median onset time of 506 days. Weibull distribution modeling indicated that DMF's failure pattern aligned with an early failure-type curve.
Conclusion:
DMF use is associated with an increased risk of fracture-related AEs, with demographic variations in susceptibility. This study provides critical insights into the safety profile of DMF in MS management, underscoring the need for vigilance in high-risk populations.
Insights
Dimethyl fumarate (DMF) increases fracture risks in multiple sclerosis (MS) patients, particularly spinal fusion and coccyx fractures. Susceptibility varies by age and gender, necessitating vigilance in high-risk groups.
Area of Science:
- Pharmacovigilance
- Neurology
- Bone Health
Background:
- Dimethyl fumarate (DMF) is a first-line treatment for multiple sclerosis (MS).
- Understanding DMF's adverse events (AEs) is crucial for patient safety.
- Fracture-related AEs are a significant concern in MS management.
Purpose of the Study:
- To investigate the association between dimethyl fumarate (DMF) and fracture-related adverse events (AEs).
- To identify specific fracture types and demographic patterns linked to DMF use.
- To assess the temporal relationship between DMF treatment and fracture onset.
Main Methods:
- Utilized disproportionality analysis on FDA Adverse Event Reporting System (FAERS) data (2004-2024).
- Employed statistical measures including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayes Geometric Mean (EBGM).
- Conducted age- and gender-specific subgroup analyses and Weibull distribution modeling for temporal analysis.
Main Results:
- Strongest signals for spinal fusion fracture (ROR=13.13) and coccyx fracture (ROR=3.05) were identified.
- Significant gender and age heterogeneity in fracture risks observed.
- Elderly patients showed increased forearm and ankle fracture risks; younger patients exhibited multi-site fractures. 63.62% of fractures occurred within 2 years, with a median onset of 506 days.
Conclusions:
- Dimethyl fumarate (DMF) use is linked to an elevated risk of fracture-related adverse events (AEs).
- Fracture risk associated with DMF shows significant demographic variations.
- Clinical vigilance is essential for managing DMF safety, especially in susceptible populations.
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