Infectious adverse events associated with immune checkpoint inhibitors: a pharmacovigilance analysis based on FAERS database.

ABSTRACT:

Background

Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, but their association with infectious adverse events (iAEs) remains incompletely characterized. These infections may arise from immune dysregulation or immunosuppressive therapies used to manage immune-related toxicities, posing significant clinical challenges. This study aims to define the spectrum, proportion, timing, and clinical outcomes of iAEs in patients treated with ICIs.

Method

Data from the first quarter of 2011 to the fourth quarter of 2023 in FAERS database were extracted to conduct disproportionality analysis. Two signal indices, the reporting odds ratio (ROR) and the information component (IC), which are based on statistical shrinkage transformation, were used to evaluate the c

SUBMITTER: Song S 

PROVIDER: S-EPMC12589035 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature