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

Abstract

e24102 Background: Objective To introduce the risk of adverse events (AE) of atezolizumab and provide a reference for the safe clinical application of this drug. Methods: Atezolizumab 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 (adverse events occurred 38,531,848 cases), of which the number of patients in the target drug population was 18,907 (46,135 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 18,907 AE reports with atezolizumab as the primary suspected drug were collected, (6543 (34.61%) female, 10,092 (53.38%) male, 2,272 (12.02%) unknown gender) involving 3,039 PTs . Calculated using the ROR and PRR combined detection method, there were a total of 827 positive PT signals. The top five risk signals caused by atezolizumab are systemic immune activation (ROR (95% CI) 625.85 (320.40-1222.49), PRR (Chi-Square) 625.65 (5345.58)); Urinary occult blood (ROR (95%CI) 307.38 (129.21-731.24), PRR (Chi-Square) 307.34 (1561.93); polyradiculoneuropathy (ROR (95% CI) 312.84 (82.99-1179.29), PRR (Chi-Square) 312.82 (678.17)); within Secretion toxicity (ROR (95% CI) 171.15 (79.98-366.25), PRR (Chi-Square) 171.12 (1122.69)); hyperprogressive tumors (ROR (95% CI) 124.85 (77.09-202.22), PRR (Chi-Square) 124.80 (2029.72)). The top 5 SOCs were 6788 (14.71%) cases of systemic diseases and various reactions at the administration site, 4889 (10.60%) cases of gastrointestinal system diseases, and 3780 cases of various examinations (8.19%), 3548 (7.69%) cases of respiratory system, chest and mediastinal diseases, and 3457 (7.49%) cases of infections and infectious diseases. Conclusions: The risk signal for autoimmune diseases caused by atezolizumab is relatively strong. It is recommended that clinicians should pay attention to possible autoimmune diseases of various systems during medication.