Global burden of TNF-α inhibitors associated demyelinating diseases: A global disproportionality analysis.

ABSTRACT: Despite case reports linking tumor necrosis factor-alpha (TNF-α) inhibitors to demyelinating diseases, large-scale epidemiological evidence is limited. We aimed to investigate this signal detection using a global pharmacovigilance database. This study identified reports of TNF-α inhibitor-associated demyelinating disease utilizing a global pharmacovigilance database spanning from 1968 to 2024. Five TNF-α inhibitors (infliximab, adalimumab, etanercept, certolizumab pegol, and golimumab) were included in this study. The signal detection between TNF-α inhibitors and demyelinating disease was evaluated using disproportionality analysis with 2 metrics: the information component (IC) with a threshold of IC025, and the reporting odds ratio (ROR) with a 95% confidence interval (CI). Statistical si

SUBMITTER: Kim TH 

PROVIDER: S-EPMC12643773 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature