Disproportionality analysis of drug-associated progressive multifocal leukoencephalopathy: roles of underlying diseases and immunomodulatory therapies in FAERS.

ABSTRACT:

Background

Progressive multifocal leukoencephalopathy (PML), a rare and often fatal JC virus-mediated disease, is a significant concern in immunocompromised patients.

Objective

Following READUS-PV guidelines, this study evaluated disproportionality signals for PML associated with specific drugs and underlying diseases using the FDA Adverse Event Reporting System (FAERS).

Methods

We identified PML cases in FAERS (2004 Q1-2024 Q4) and excluded those associated with HIV/AIDS. For drugs with ≥3 PML reports, disproportionality was assessed using the reporting odds ratio (ROR) and proportional reporting ratio (PRR), reported with 95% confidence intervals and χ² statistics, respectively. Subgroup analyses were conducted by age, sex, reporting region, and patient outcome. We

SUBMITTER: Lin X 

PROVIDER: S-EPMC12807927 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature