Abstract Details

Title Urinary Tract Infections and Urosepsis in Multiple Sclerosis: Insights from FDA Pharmacovigilance Data

Topic Practice, Policy, and Ethics

Presentation(s) S12 - Practice, Policy and Ethics (2:12 PM-2:24 PM)

Poster/Presentation
Number 007

Objective To evaluate the risks of urinary tract infections (UTI) and urosepsis across multiple sclerosis (MS) disease-modifying therapies (DMTs) using publicly available pharmacovigilance data.

Background UTIs and resulting urosepsis are a common cause of morbidity and mortality among people with MS. These risks are amplified by neurogenic bladder dysfunction and immunomodulation from MS DMTs. However, the relative contribution of specific DMTs to UTI and urosepsis risk remains underexplored.

Design/Methods

The FDA Adverse Event Reporting System (FAERS) was analyzed using the OpenVigil 2.1 platform to identify disproportionally high reporting of UTI and urosepsis among DMTs compared with other FAERS medications. Reports from October 2003 to December 2024 were included and stratified by sex and age (≤50 and ≥51 years). Disproportionality was assessed using reporting odds ratios (RORs), 95% confidence intervals, and chi-square testing with Yates correction. Only reports where a DMT was the primary suspect drug were included.

Results Across DMTs, 12,997 reports of UTI and 651 of urosepsis were identified in people with MS. Ocrelizumab had the greatest association with UTI, and natalizumab, alemtuzumab, and interferon-beta-1a exhibited safety signals for both outcomes across all sex and age subgroups. Hospitalization occurred in nearly 7,000 cases, and more than 500 deaths were reported.

Conclusions This real-world pharmacovigilance analysis identifies disproportionate reporting of UTI and urosepsis across several MS DMTs, underscoring their contribution to morbidity and mortality. These associations likely reflect both therapy-related immunologic effects and disease-intrinsic factors, particularly neurogenic bladder dysfunction. These findings highlight the need for vigilant infection surveillance, proactive bladder management, and individualized risk assessment in MS care.

Authors/Disclosures
Tamara B. Kaplan, MD, FAAN (Brigham and Women'S Hospital) PRESENTER	Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono . Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech.
Alexandra R. Balshi	Ms. Balshi has nothing to disclose.
Madelyn Esser	Ms. Esser has nothing to disclose.

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