Thyroid immune-related adverse reactions of immune checkpoint inhibitors

doi:10.19803/j.1672-8629.20210968

Abstract

Abstract: Objective To explore the feasibility of active monitoring of drugs based on the Chinese Pharmacovigilance System (CHPS) in order to provide data for related research. Methods Based on the data from the CHPS of two sentinel hospitals, the information about tumor patients who had used ICIs and those who had not used ICIs between January 1, 2020 and June 30, 2021 was retrieved as controls. Based on the generalized estimation equation, the thyroid immune-related adverse reactions of ICIs were explored. Results A total of 1 691 patients were included, including 666 in the ICIs group and 1 025 in the control group. The generalized estimating equation model was used to process the follow-up data of patients while taking into consideration all the correlations between repeated measurement data. Tt was found that overt thyrotoxicosis was statistically significant (P<0.05). The incidence was 4.50%, and the median time to onset (TTO) was 41.5 days. Conclusion ICIs may cause overt thyrotoxicosis. When applying ICIs to patients, clinicians should be alert to the occurrence of overt thyrotoxicosis to ensure the safety of medications.

Key words: immune checkpoint inhibitors (ICIs), thyroid, Chinese Hospital Pharmacovigilance System (CHPS), active monitoring, adverse drug reactions

CLC Number:

ZHENG Yi, ZHAI Yinghong, GUO Xiaojing, XU Jinfang, CHI Lijie, GUO Zhijian, CHEN Chenxin, LIANG Jizhou, WEI Lianhui, CHEN Xiao, YE Xiaofei, HE Jia. Thyroid immune-related adverse reactions of immune checkpoint inhibitors[J]. Chinese Journal of Pharmacovigilance, 2023, 20(1): 92-95.

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