Adverse reactions of immune checkpoint inhibitors combined with glucocorticoids: a pharmacovigilance analysis of drug-drug interactions

This study investigated the risks of drug-drug interaction (DDI) between immune checkpoint inhibitors (ICIs) and glucocorticoids (GCs) using the FDA Adverse Event Reporting System (FAERS) data from 2004 to 2024. A total of 2,279,969 adverse event reports were analyzed, employing several methods to find key DDI. Three main types of adverse events showed clear signals: metabolism and nutrition disorders (ROR=2.49), gastrointestinal disorders (ROR=1.42), and investigations (ROR=1.35). PD-1/PD-L1 inhibitors combined with GCs had the higher risks than CTLA-4 inhibitors. This study shows doctors should watch closely for high blood sugar and gut problems in patients taking PD-1/PD-L1 inhibitors with GCs. Preclinical trials and robust clinical studies are required to explore the mechanisms and relationships underlying interactions, thus improving understanding of DDI associated with this combination therapy.