Adverse reactions of immune checkpoint inhibitor myocarditis based on active monitoring system

doi:10.19803/j.1672-8629.20230106

Abstract

Abstract: Objective To explore the feasibility of active surveillance of adverse drug reactions based on the China Hospital Pharmacovigilance System, taking adverse reactions to immune checkpoint inhibitors in myocarditis as an example, and to provide a corresponding basis for related studies. Methods Based on data from the China Hospital Pharmacovigilance System at a sentinel hospital in Chongqing between June 1, 2018 to June 1, 2022, information on tumor patients who had applied immune checkpoint inhibitors and tumor patients who had not used immune checkpoint inhibitors were extracted as controls, and the observed confounding factors between the two groups were controlled by using propensity score matching 1 : 4. Predictive models for myocarditis were constructed based on several commonly used machine learning algorithms and logistic regression, and the model with the best predictive efficacy was selected as the predictive model for myocarditis to identify whether patients had myocarditis, and the two groups were subsequently compared to explore whether immune checkpoint inhibitors increase the risk of myocarditis. Results A total of 15 589 patients were included in this study, including 3 496 in the immune checkpoint inhibitor group and 12 083 in the control group. The best predictive efficacy of random forest (AUC=0.948, ACC=0.988, precision=1.000, recall=0.545, F1 score=0.706) was used as a predictive model for myocarditis. Based on this model to identify whether myocarditis occurred in the patients included in the study, 64 (1.83%) of the immune checkpoint inhibitor group had myocarditis and 160 (1.32%) of the control group, the difference in incidence between the two groups was P<0.05, and the difference in incidence between the two groups was statistically significant. Conclusion The application of immune checkpoint inhibitors increases the risk of myocarditis, and clinicians should pay attention to the occurrence of myocarditis when applying immune checkpoint inhibitors to patients to ensure the safety of patients' medication.

Key words: immune checkpoint inhibitors, myocarditis, tumor, CHPS, active surveillance, machine learning, adverse drug reactions

CLC Number:

R979.5
R994

ZHENG Yi, LUO Xiao, ZHANG Pengpeng, LIU Yongmei, YE Xiaofei, GUO Xiaojing, CHEN Xia, HE Jia. Adverse reactions of immune checkpoint inhibitor myocarditis based on active monitoring system[J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 634-638.

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