Expert opinion on drug safety · 2025
Analysis of diroximel fumarate data for patients with relapsing forms of multiple sclerosis using related adverse events from the FDA adverse reporting system.
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Yang Jing-Ya, Sun Sheng-Zhu, Sun Yi-Yan, Zuo Tian-Qi, Li Xiao-Tong, Zhao Lei-Yong, Wu Hong-Yun, Peng Wei
Аннотация
BACKGROUND: Diroximel fumarate (DRF) is an oral fumarate used to treat relapsing forms of multiple sclerosis (RMS). This study comprehensively analyzed the adverse events (AEs) associated with DRF for treating RMS based on data from the FDA Adverse Event Reporting System (FAERS) database.
RESEARCH DESIGN AND METHODS: This study collected data on AEs associated with DRF treatment of RMS from the FAERS database between 2019 and 2024. We used reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) for signal detection.
RESULTS: This study collected 7,944,554 AE reports, of which 7,868 were associated with DRF. A total of 120 preferred terms (PTs) were included in the analysis, relating to 27 system organ classes (SOCs). This study identified several clinically significant new potential AEs, including decreased immune responsiveness (n = 26, ROR 4.45, PRR 4.45, IC 2.15, EBGM 4.43), female breast cancer (n = 50, ROR 4.07, PRR 4.07, IC 2.02, EBGM 4.05), transient blindness (n = 19, ROR 7.27, PRR 7.26, IC 2.85, EBGM 7.21) and others.
CONCLUSIONS: Our study identified several potentially important AEs that were not mentioned in the DRF instructions. However, further epidemiologic studies are needed to validate these findings.
RESEARCH DESIGN AND METHODS: This study collected data on AEs associated with DRF treatment of RMS from the FAERS database between 2019 and 2024. We used reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) for signal detection.
RESULTS: This study collected 7,944,554 AE reports, of which 7,868 were associated with DRF. A total of 120 preferred terms (PTs) were included in the analysis, relating to 27 system organ classes (SOCs). This study identified several clinically significant new potential AEs, including decreased immune responsiveness (n = 26, ROR 4.45, PRR 4.45, IC 2.15, EBGM 4.43), female breast cancer (n = 50, ROR 4.07, PRR 4.07, IC 2.02, EBGM 4.05), transient blindness (n = 19, ROR 7.27, PRR 7.26, IC 2.85, EBGM 7.21) and others.
CONCLUSIONS: Our study identified several potentially important AEs that were not mentioned in the DRF instructions. However, further epidemiologic studies are needed to validate these findings.