Cardiac arrhythmias associated with S1RPMs: a pharmacovigilance study based on real-world data

Background Sphingosine-1-phosphate receptor modulators (S1PRMs) are an effective class of disease-modifying therapies (DMTs) for the treatment of multiple sclerosis (MS). But its clinical application is limited due to its adverse reactions. Methods In this study we mined cardiac arrhythmias adverse event signals of S1PRMs based on the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the first quarter of 2024, using the Reported Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confdence Propagation Neural Network (BCPNN) and Multi-item Gamma Poisson Shrinker (MGPS) methods to provide a reference for the safe clinical use of the drug. Results We identified 2,059 arrhythmia-related adverse events associated with S1PRMs, including 1,860 cases for fingolimod, 153 for siponimod, 38 for ozanimod, and 8 for ponesimod. Patients aged 18–65 and female patients were at a higher risk. High risk signals in the report include heart rate decreased, cardiac flutter, extrasystoles. Conclusion Mining the adverse reaction signal study of S1PRMs based on the FAERS database provides some support for the clinical monitoring and risk identification of this drug.