Immune-related adverse events associated with nivolumab: Analysis of the FAERS database in the United States.

e24126 Background: To describe the risk of nivolumab adverse events (AEs) and to provide a reference for the safe clinical to use this drug. Methods: Nivolumab AE reports from January 2014 to December 2023 were collected from the FDA Adverse Event Reporting System, with a total of 133,12811 background patients (3,853,1848 occurrences of adverse events) included in the analysis, of which the number of patients in the target drug population was 60,625 (16,512 occurrences of adverse events). The number of patients in the target drug population was 60625 (161512 adverse events). Signals were detected using the Reporting Odds Ratio (ROR) method in conjunction with the Proportional Reporting Ratio (PRR), with signal judgment thresholds typically using a ≥ 3, and the lower limit of the 95% confidence interval for the ROR being greater than 1, The ROR and PRR (using a ≥ 3, and the lower limit of the 95% confidence interval for the ROR being greater than 1) were compared to the PRR. When ROR and PRR (using a ≥ 3, PRR ≥ 2 and chi-square ≥ 4 as thresholds) were used in combination, signal crossover between the two methods was defined as a positive risk signal. The preferred system organ classification (SOC) and preferred terminology (PT) of the current version of the MedDRA dictionary were used to classify AEs, and the top 30 PTs in terms of AE signal intensity were selected for analysis. Results: A total of 161,512 reports of AE with nivolumab as the first suspected drug were collected, involving 5174 PTs. A total of 995 positive PT signals were calculated using the combined ROR and PRR assay. The top 5 risk signals induced by nivolumab were immune-mediated small bowel colitis (ROR (95% CI) 114.42 (103.26-126.79), PRR (Chi-Square) 114.04 (40959.8)), pituitary gland inflammation (ROR (95% CI) PRR (Chi-Square) 88.60 ( 79.17-99.15)PRR(Chi-Square)88.37(26256.6)), fulminant type 1 diabetes mellitus (ROR(95% CI)213.73(183.24-249.30),PRR(Chi-Square)213.33(34295.5)) immune-mediated pneumonias (ROR(95% CI) 114.08 (99.42-130.89),PRR(Chi-Square) 113.87 (22764.4)), immune-mediated hepatitis (ROR(95% CI) 86.09 (75.08-98.71),PRR(Chi-Square) 85.94 (17262.8)).The top 5 SOCs were systemic diseases and various reactions at the site of administration in 25447 cases (15.76%), gastrointestinal disorders in 25447 cases(15.76%), gastrointestinal disorders 16,282 cases (10.08%), various types of injuries, poisoning and operational complications 12,510 cases (7.57%), respiratory, thoracic and mediastinal disorders 11,572 cases (7.16%), as well as benign, malignant, and tumors of undetermined nature (including cystic and polypoid) 10,486 cases (6.49%). Conclusions: The risk signal of autoimmune diseases caused by nivolumab is relatively strong, and it is recommended that clinicians should pay attention to the possible autoimmune diseases of various systems during the use of the drug.