Pharmacovigilance Insights Into Immune Checkpoint Inhibitor-Induced Risk of Paraneoplastic Syndrome: A Large-Scale Real World Study.

ABSTRACT:

Background

Immune checkpoint inhibitor (ICI)-associated paraneoplastic syndromes (PS) represent a rare but potentially life-threatening adverse event. Despite the widespread use of ICIs in cancer treatment, the clinical characteristics and risk profiles of PS across different treatment regimens remain incompletely characterized.

Methods

We analyzed FAERS data (Jan 2011-Jun 2024) to identify PS cases potentially related to ICI use. Reporting odds ratios (RORs) were calculated to evaluate safety signals. Clinical features, time-to-onset, and outcomes were analyzed across different ICI regimens.

Results

Among 162,493 ICI-associated adverse event reports, 179 PS cases were identified. Disproportionate reporting of PS was observed with PD-1 inhibitors (ROR 21.77, 95% CI 16

SUBMITTER: Tang B 

PROVIDER: S-EPMC12820717 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature