Real-world pharmacovigilance analysis of the association between multiple sclerosis disease-modifying therapies and...

This study aims to investigate the potential association between 13 disease-modifying immunosuppressive drugs used to treat multiple sclerosis and intervertebral disc herniation, thereby filling a gap in pharmacovigilance research in this field.

We extracted adverse event reports from the FAERS database covering 2005 to 2025. Disproportionality analyses using four established algorithms (ROR, PRR, EBGM and IC) with unified predefined thresholds were performed. We also conducted subgroup analyses and explored the temporal characteristics of adverse event onset. Results: Teriflunomide, natalizumab and ocrelizumab have shown positive disproportionality signals for intervertebral disc herniation. And these signals merely reflect statistical associations and do not confirm causality. Among these, men and young-to-middle-aged adults populations presented relatively higher disproportionality signal values. Furthermore, teriflunomide-associated intervertebral disc herniation exhibits characteristics of early-onset risk, whereas there is no clear temporal clustering of events associated with natalizumab and ocrelizumab.

Three medications demonstrated positive disproportionality reporting signals for intervertebral disc herniation, which require further validation. Clinicians are suggested to raise vigilance on spinal adverse events and tailor therapeutic strategies when prescribing these agents for multiple sclerosis management.