A disproportionality analysis of surgical site infections across multiple sclerosis disease modifying therapies.

Balshi, Alexandra; Dempsey, John; Manning, Nova; Leuenberger, Grace; Baber, Ursela; Sloane, Jacob A.

Background and objective: People with multiple sclerosis (PwMS) may be at an increased risk of surgical site infections (SSIs). However, the role of specific MS disease-modifying therapies (DMTs) in modulating this risk remains underexplored. Methods: The FDA Adverse Event Reporting System (FAERS) was used to investigate if MS DMTs are associated with disproportionally higher SSI reporting compared to other FAERS medications for individuals of all ages and those over the age of 50. Results: We identified 769 reports of SSIs across MS DMTs (352 in PwMS aged 50 or older) and 21 SSI-associated deaths. A pooled analysis of all DMTs revealed increased risks of SSIs (reporting odds ratio [ROR] of 1.95, 95% confidence interval [CI] 1.80–2.12) for all age groups and for those 50 or older (ROR of 2.58, 95% CI 2.27–2.92). For both age groups, ocrelizumab and interferon beta-1a met Evan’s threshold for disproportionally high SSI reporting compared to all other FAERS medications. Conclusion: MS DMTs are collectively associated with disproportionately high SSI reporting, especially for PwMS over the age of 50, with ocrelizumab and interferon beta-1a increasing SSI reporting risk in both age groups. These findings reveal a need to take extra precautions when caring for PwMS in a surgical setting, such as engaging wound care teams to minimize SSI risk.

Journal of Neurology, 2025, Vol 272, Issue 3, p1

0340-5354

Academic Journal

10.1007/s00415-025-12980-x