PD-1/PD-L1 inhibitors-associated cardiac adverse events: a retrospective and real-world study based on the FDA...

Area of Science:

• Cardiology
• Oncology
• Pharmacovigilance

Background:

• Immune checkpoint inhibitors (ICIs) targeting PD-1/PD-L1 have transformed cancer treatment.
• While effective, these therapies can induce rare but potentially fatal adverse events.
• Understanding ICI-related cardiotoxicity is critical for patient management.

Purpose of the Study:

• To analyze cardiac adverse events (AEs) associated with PD-1/PD-L1 inhibitors.
• To identify patterns in cardiotoxicity, including primary tumor type, onset time, and patient demographics.
• To compare different PD-1/PD-L1 inhibitors regarding cardiac safety profiles.

Main Methods:

• Analysis of FDA Adverse Event Reporting System (FAERS) data from July 2014 to June 2022.
• Utilized signal index reporting odds ratio (ROR) to assess drug-cardiac AE correlation.
• Compared indications and time to onset (TTO) for various PD-1/PD-L1 inhibitors.

Main Results:

• Identified 11,538 reports of cardiotoxicity linked to PD-1/PD-L1 inhibitors.
• Cardiac AEs, particularly myocardial and pericardial disorders, showed signals across all studied medications.
• These events commonly occurred within the first 1-2 months, with non-small cell neoplasm being the most frequent indication.

Conclusions:

• Cardiac AEs associated with PD-1/PD-L1 inhibitors are rare but can be fatal.
• Specific risk profiles exist concerning tumor type, onset timing, and gender.
• Findings support enhanced early diagnosis and surveillance strategies for ICI-related cardiotoxicity.