Immune checkpoint inhibitor rechallenge after immune-related adverse events: a retrospective study from VigiBase update in 2024 looking for emergent safety signals.

ABSTRACT:

Objectives

Limited information is available on the safety of a rechallenge with an immune checkpoint inhibitor (ICI) after occurrence of an immune-related adverse event (irAE). We aim to identify potential emergent safety signals.

Design

This is an update of our observational pharmacovigilance cohort study.

Setting

We exanimated individual case safety reports from the WHO database VigiBase.

Participants

We included all individual case safety reports with ICI and rechallenged ICI.

Interventions

We identified that incident irAE cases using the Medical Dictionary for Regulatory Activities V.26.1 related with at least one ICI administration were systematically collected until 1 March 2024.

Primary and secondary outcome measures

The primary outcome was

SUBMITTER: L'Orphelin JM 

PROVIDER: S-EPMC11624719 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature