Neuroinvasive Infections in Animal Studies of Multiple Sclerosis Disease-Modifying Therapies
This research analyzed 492,514 reports related to non-PML neuroinvasive infections tied to multiple sclerosis disease-modifying therapies (DMTs), identifying varying risks across therapies. Alemtuzumab showed the highest association with bacterial infections, while anti-CD20 therapies were linked to viral infections.
- Tags
- #MSResearch
- Most relevant to
- —
- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- Not graded
- Outcome
- Not reported
Why it matters
Understanding the association between DMTs and neuroinvasive infections can guide future pharmacovigilance efforts and improve patient safety in multiple sclerosis management.
What this does not prove
The study did not estimate the incidence of infections or establish direct causality between therapy and infection. Reporting comparisons were not formal tests which may affect interpretation.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- 2026-10-13
- Evidence reviewed
- Abstract only
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Not reported
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
- Primary evidenceNon-PML neuroinvasive infections reported with multiple sclerosis disease-modifying therapies: a mechanism-based pharmacovigilance study, 2004-2025. ↗DOI: 10.3389/fimmu.2026.1959164
Supporting passages (6)
publication datePublication date: 2026-10-13
interventionBACKGROUND: Multiple sclerosis (MS) disease-modifying therapies (DMTs) alter host immunity and may produce pathogen-specific susceptibility to neuroinvasive infection.
primary endpointTitle: Non-PML neuroinvasive infections reported with multiple sclerosis disease-modifying therapies: a mechanism-based pharmacovigilance study, 2004-2025.
findingsRESULTS: Among 492,514 reports, 675 were tier A and 82 additional reports were tier B. Tier A aRORs (95% CIs) were 0.82 (0.63-1.05) for anti-CD20 therapies, 1.77 (1.44-2.16) for S1P modulators, 1.32 (1.06-1.64) for natalizumab, 3.28 (2.24-4.66) for alemtuzumab, and 0.56 (0.21-1.19) for cladribine. Fingolimod accounted for 145 of 152 S1P cases and had an aROR of 2.15 (1.75-2.64). Among four mechanisms eligible for E2, pathogen composition differed (LRT 210.59, 9 df; bootstrap P = 9.99 × 10-4): viral reports were enriched with anti-CD20 therapies (OR 4.24, 2.56-7.02) and natalizumab (2.03, 1.26-3.26), fungal reports with S1P modulators (29.09, 15.77-53.64), and bacterial reports with alemtuzumab (4.99, 2.27-11.01). Only natalizumab-HSV/VZV met the adjusted E3 gate and showed CNS enrichment (aROR 2.80, 1.80-4.38; Holm-adjusted P = 5.81 × 10-6).
limitationsTitle: Non-PML neuroinvasive infections reported with multiple sclerosis disease-modifying therapies: a mechanism-based pharmacovigilance study, 2004-2025.
peer reviewedPublication types: Journal Article
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