Immune checkpoint inhibitor-associated myocarditisand pericarditis: A pharmacovigilance study based on the FAERS database

<br>ICIs(Immune checkpoint inhibitors) are drugs used in cancer treatment through immunotherapy.However, corresponding adverse reactions can also occur during treatment,especifically for myocarditis and pericarditis, there has not yet been a systematic study. This is a real-world pharmacovigilance study on the association of ICIs with myocarditis and pericarditis based on the FAERS (U.S. FDA Adverse Event Reporting System) database.The data of myocarditis and pericarditis related to ICIs were extracted from the FAERS database during 2014Q1 to 2023Q4. We used Bayesian Confidence Propagation Neural Network (BCPNN) and the Reporting Odds Ratio (ROR)for data mining.Additionally, this study does not involve privacy concerns and does not require ethical review.This study utilized RStudio 4.4.2, SPSS 29.0, and Microsoft Excel 2016 for statistical processing and analysis of the data. The analysis included the number of reports (annual reports, gender, age, weight, reporting population, country, outcomes, indications, onset time, and concomitant medications), the number of reports for all positive AE signals, ROR (95% CI), and IC (IC025) values. Data were expressed as counts and percentages, while non-normally distributed data were expressed as medians (interquartile ranges). Univariate logistic regression analysis was employed to identify risk factors associated with ICIs-related noninfectious myocarditis/pericarditis. The analysis integrated the Demo table (including age, gender, and weight), Drug table (including drug names), Indi table (including indications), Outc table (including outcome measures), Reac table (including medication start time and adverse event reporting time), and Ther table (including drug treatments) for the five drugs. A total of 86,266 AE reports were initially collected, and after excluding reports with missing information, 10,278 reports were ultimately included. Gender, age, weight, concomitant medications, and time were treated as variables. The odds ratios and confidence intervals were used to analyze the impact of gender, age, weight, concomitant medications, and time on the occurrence of ICIs-related noninfectious myocarditis/pericarditis. A P-value&lt;0.05 was considered statistically significant.<br><br><br><br><br><br><br>