| アブストラクト | OBJECTIVE: To analyze the difference in the post-approval adverse drug events (ADEs) of dupilumab between pediatric and adult populations, using data from the Adverse Event Reporting System (FAERS) database to provide a reference for the safe use of dupilumab in clinical practice. METHODS: Information on dupilumab-associated ADEs was extracted from the FAERS database from 2017 (second quarter) to 2024 (fourth quarter). The data were grouped by age (children <18 years vs. adults >/=18 years). RESULTS: A total of 210 300 ADE reports were included (20 065 in children and 112 508 in adults). Positive signals involved 14 and 20 System Organ Classes (SOCs) in children and adults, respectively, involving 126 Preferred Terms (PTs) that were reported both in children and adults, such as rebound eczema, product use in unapproved indication, and therapeutic response shortened, as well as 24 PTs that were unique to children, such as enterobiasis, periorbital pain, vitiligo, oral mucosal eruption, and alopecia, and 156 PTs that were unique to adults, such as sub-conjunctival fibrosis, conjunctival papillae, ocular rosacea, and cutaneous T-cell lymphoma. The median Time-To-Onset (TTO) of ADEs was 0 and 14 days in children and adults, respectively. CONCLUSION: There were significant differences in the ADE profiles of dupilumab between children and adults. Optimization of the monitoring strategy according to age is thus necessary in clinical settings, together with an awareness of the above new suspected high-risk signals that are not mentioned in the package insert. |
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| ジャーナル名 | European journal of pharmacology |
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| Pubmed追加日 | 2025/8/31 |
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| 投稿者 | Zhou, Jing; Xie, Yuanyuan; Du, Pengcheng; Chen, Meiling; Liu, Xiaojin |
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| 組織名 | Department of Clinical Pharmacy, Qilu Hospital of Shandong University Dezhou;Hospital, Dezhou, Shandong, China.;Department of Clinical Research Center for Pharmaceuticals, Qilu Hospital of;Shandong University Dezhou Hospital, Dezhou, Shandong, China. Electronic address:;xiaojin8208@163.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40885234/ |
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