Immunotherapy-related adverse events (irAEs): extraction from FDA drug labels and comparative analysis

Objectives: Immune checkpoint inhibitors (ICIs) have dramatically improved outcomes in cancer patients. However, ICIs are associated with significant immune-related adverse events (irAEs) and the underlying biological mechanisms are not well-understood. To ensure safe cancer treatment, research efforts are needed to comprehensively detect and understand irAEs. Materials and Methods: We manually extracted and standardized irAEs from FDA drug labels for six FDA-approved ICIs. We compared irAE profile similarities among ICIs and 1,507 FDA-approved non-ICI drugs. We investigated how irAEs have differential effects on human organs by classifying irAEs based on their targeted organ systems. Finally, we identified broad-spectrum (non-target specific) and narrow-spectrum (target-specific) irAEs. Results: A total of 893 irAEs were extracted. 31.4% irAEs were shared among ICIs as compared to the 8.0% between ICIs and non-ICI drugs. irAEs were resulted from both on- and off-target effects: irAE pr...