Objective  To mine and analyze cutaneous adverse drug event (ADE) of eight antibody-drug conjugates (ADC), and to ensure the safe clinical use of ADC drugs.

Methods  The data was obtained from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) for the period from the third quarter of 2011 to the fourth quarter of 2023. The cutaneous ADE associated with 8 eight ADC drugs were identified through the process of specification and standardization of nomenclature. The potential ADE signals were detected using the reporting odds ratio and Bayesian confidence propagation neural network  methods.

Results  A total of 124 234 ADE reports were identified with the 8 ADC drugs as the first suspected drugs, including 5 184 reports of cutaneous ADEs adverse reactions, involving 3 225 patients. A total of 72 preferred term signals were detected for the 8 ADC drugs. The highest number of signals were detected for enfortumab vedotin, followed by ado-trastuzumab emtansine and brentuximab vedotin. Except for detrolizumab, the first-day incidence of cutaneous ADEs associated with the remaining 7 ADC drugs was less than 30%. The median time of occurrence for the 7 drugs, excluding brentuximab vedotin, was within one course of treatment (21 d).

Conclusion  The risks of cutaneous ADEs was variable with ADC drugs, occurs early in treatment and poses a potential life-threatening danger. Therefore, clinical vigilance and close monitoring of skin conditions are essential during ADC drug use.

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