Chen Yanhua, Ni Jiang, Li Ming, Hong Yuan, Zhu Kouzhu, Hong Rong, Deng Li, Li Zhijie, Pu Jie, Yang Ting, Wang Yan
Department of Pharmacy, Affiliated Children's Hospital of Jiangnan University (Wuxi Children's Hospital), Wuxi, Jiangsu, China.
Department of Pharmacy, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.
Front Pediatr. 2025 Jan 17;12:1524962. doi: 10.3389/fped.2024.1524962. eCollection 2024.
This study analyzes the occurrence and characteristics of adverse drug reactions (ADRs) of dupilumab in children in a real-world setting. It aims to enhance clinical practice and minimize medication safety risks in pediatric patients.
This prospective study included children receiving dupilumab in the hospital between January 2022 and December 2023. Information on ADRs was collected and univariate and multivariate analyses were employed to identify high-risk factors for the occurrence of adverse effects in dupilumab treatment.
A total of 65 ADRs occurred in 1,103 treatments in 127 patients, with an incidence of 27.56% (35/127). A total of 62 patients aged 6 or below participated in this study, accounting for 48.82%. Univariate analysis showed that gender, age, duration of medication, frequency of dupilumab use were risk factors for the occurrence of adverse effects ( < 0.05). Multivariate logistic regression analysis showed that age [odds ratio [OR]: 0.071, 95% confidence interval [CI]: 0.012-0.433; = 0.004] and frequency of dupilumab use (OR: 3.306, 95% CI: 1.078-10.135; = 0.036) were risk factors for adverse effects. The outcomes of ADRs were improved in 10 cases (15.38%) and completely recovered in 55 cases (84.62%).
Dupilumab has a good safety profile in Chinese children aged 6 months to 18 years for up to 2 years of treatment, with most adverse reactions being mild to moderate, and no serious ocular adverse reactions were reported. Age and frequency of dupilumab use were risk factors for adverse effects. Younger age and higher frequency of dupilumab use were associated with higher odds of ADRs.
本研究分析度普利尤单抗在真实世界中儿童患者药物不良反应（ADR）的发生情况及特点，旨在改善临床实践并降低儿科患者用药安全风险。
本前瞻性研究纳入了2022年1月至2023年12月期间在医院接受度普利尤单抗治疗的儿童。收集ADR信息，并采用单因素和多因素分析来确定度普利尤单抗治疗中发生不良反应的高危因素。
127例患者的1103次治疗中共发生65例ADR，发生率为27.56%（35/127）。共有62例6岁及以下儿童参与本研究，占48.82%。单因素分析显示，性别、年龄、用药时长、度普利尤单抗使用频率是发生不良反应的危险因素（P<0.05）。多因素logistic回归分析显示，年龄[比值比（OR）：0.071，95%置信区间（CI）：0.012 - 0.433；P = 0.004]和度普利尤单抗使用频率（OR：3.306，95%CI：1.078 - 10.135；P = 0.036）是不良反应的危险因素。10例（15.38%）ADR结局改善，55例（84.62%）完全恢复。
度普利尤单抗在6个月至18岁的中国儿童中进行长达2年的治疗时具有良好的安全性，大多数不良反应为轻至中度，未报告严重眼部不良反应。年龄和度普利尤单抗使用频率是不良反应的危险因素。年龄越小、度普利尤单抗使用频率越高，发生ADR的几率越高。
