Adverse events caused by HER2 conjugated antibodies via FAERS

doi:10.19803/j.1672-8629.20220658

Abstract

Abstract: Objective To provide reference for clinical drug safety by mining and analyzing adverse drug reaction/event (ADR/ADE) signals of T-DM1 and T-DXd which are antibody-conjugated drugs targeting HER2. Methods ADR/ADE reports submitted between January 1, 2020 and June 30, 2022 were retrieved from the Adverse Event Reporting System of the United States Food and Drug Administration (FAERS) before signals were screened and analyzed after removal of duplicate reports. Results A total of 2 806 ADR/ADE reports were collected with T-DM1 or T-DXd as the primary suspected drug, and 3 979 ADR/ADE signals were obtained after screening. The classification of ADR/ADE signals found that the signals of the two drugs were of a similar system organ class (SOC). However, T-DM1 was additionally involved in the reproductive system and breast disorders and vascular disorders. Furthermore, ADR/ADE signal intensities associated with T-DM1 were higher for hepatopulmonary syndrome, sideroblastic nevus and nodular aplastic hyperplasia, while T-DXd was more significantly correlated with elevated kL-6, carcinomatous lymphadenopathy and interstitial lung diseases. Among the top 20 ADR/ADE in terms of signal intensities, spider naevus, hyperalgesia and sensory abnormality were not mentioned in the instructions of T-DM1, while keratitis and femoral neck fracture were not mentioned in T-DXd instructions. Conclusion The real-world ADR/ADE mined conform with those specified in drug instructions. New ADR/ADE are also reported that can provide reference for clinical use of T-DM1 and T-DXd.

Key words: T-DM1, T-DXd, HER2, ADC, tumor, breast cancer, FAERS, ADR/ADE

CLC Number:

HE Xiong, MA Junlong, YANG Guoping. Adverse events caused by HER2 conjugated antibodies via FAERS[J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 915-920.

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