Guillain-Barre syndrome associated with immune checkpoint inhibitors exposure: a pharmacovigilance study.

ABSTRACT:

Background

Guillain-Barré syndrome (GBS) is a life-threatening condition that has been associated with exposure to immune checkpoint inhibitors (ICIs); however, available data remain limited.

Methods

We conducted a retrospective, worldwide, observational analysis of individual case safety reports in VigiBase, the World Health Organization's pharmacovigilance database. To minimize competition bias, we excluded reports of vaccines and infectious associated with a known or potential risk of GBS. Subsequently, we searched for reports of GBS linked to ICI regimens, whether as monotherapy or dual immunotherapy, from the Food and Drug Administration (FDA) approval date of each agent until 12 February 2024. The primary endpoint of this study was to assess the association between GBS

SUBMITTER: Cabon J 

PROVIDER: S-EPMC12708775 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature