Signals mining and analysis of deucravacitinib adverse drug events based on FAERS database

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Author: HU Ye ¹ GONG Qineng ² ZHANG Linlin ¹ WANG Aming ¹ QI Wang ¹  MIAO Yang ¹

Affiliation: 1. Department of Pharmacy, the First people's Hospital of Yancheng, Yancheng 224000, Jiangsu Province, China 2. Medical Research Center, the First People's Hospital of Nantong, Nantong 226001, Jiangsu Province, China

Keywords: Deucravacitinib Adverse drug events FAERS database Psoriasis Signal mining Pharmacovigilance

DOI: 10.12173/j.issn.1005-0698.202412084

Reference: HU Ye, GONG Qineng, ZHANG Linlin, WANG Aming, QI Wang, MIAO Yang. Signals mining and analysis of deucravacitinib adverse drug events based on FAERS database[J]. Yaowu Liuxingbingxue Zazhi, 2025, 34(4): 419-427. DOI: 10.12173/j.issn.1005-0698.202412084.[Article in Chinese]  Copied

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Abstract

Objective To mine adverse drug event (ADE) signals of deucravacitinib, and to guide its rational clinical use.

Methods ADE reports reported to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database from the third quarter of 2022 to the third quarter of 2024 were collected, ADE reports with deucravacitinib as the primary suspect drug were selected for analysis. ADE signals were identified using reporting adds ratios method and Bayesian confidence propagation neural networks method.

Results A total of 1,777 ADE reports were collected involving 3,258 ADEs. Sixty-two ADE signals were identified, spanning 14 system-organ classifications. The top five ADE signals based on the number of reported cases were acne, oral ulcers, folliculitis, urticaria, and oral pain. The top five ADE signals based on signal intensity were cystic acne, hepatitis A, acne vulgaris, pustular acne, and folliculitis. ADE signals such as pigmenturia, hepatitis A, and gingival swelling were not included in the drug instructions. The median duration of ADEs associated with deucravacitinib was 22 days, with 58.33% occurring within the first month of treatment. Women may have a higher risk of developing acne than men.

Conclusions When using deutericolaxitinib, healthcare professionals should focus on skin and subcutaneous tissue disorders, gastrointestinal system disorders, and infections and infestations to monitor the occurrence of acne in female patients. The latent ADEs that are not mentioned in the instructions should be remained vigilant to ensure safe drug use.

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