Analysis immune-related of pembrolizumab adverse events based on the US FAERS database.

作者：Linguo Wang, Jianhua Wang · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.e24108 · 研究领域：Cancer Immunotherapy and Biomarkers、Colorectal Cancer Treatments and Studies、Colorectal and Anal Carcinomas

e24108 Background: Objective To introduce the risk of adverse events (AE) of pembrolizumab and provide a reference for the safe clinical application of this drug. Methods: Pembrolizumab AE reports from January 2014 to December 2023 were collected from the U.S. Food and Drug Administration Adverse Event Reporting System database. A total of 13,312,811 background patients were included in the analysis (38,531,848 adverse events occurred cases), among which the number of patients in the target drug population was 39,847 (116,630 adverse events occurred). The Reporting Odds Ratio (ROR) method and the Proportional Reporting Ratio (PRR) are used to jointly detect signals. The signal judgment threshold is usually a≥3, the lower limit of the ROR95% confidence interval is greater than 1, and the lower bound of the PRR95% confidence interval is greater than 1. When ROR is combined with PRR (using a ≥ 3, PRR ≥ 2 and chi-square value ≥ 4 as the threshold), the intersection of the detection signals of the two methods is defined as a positive risk signal. The preferred system organ classification (SOC) and preferred term (PT) of the latest version of the MedDRA dictionary were used to classify AEs, and the top 30 PTs with AE signal intensity were selected for analysis. Results: a total of 116,630 AE reports with pembrolizumab as the primary suspected drug were collected, involving 5,392 PTs. Calculated using the ROR and PRR combined detection method, a total of 1082 positive PT signals wer...