Xu Yuanyuan, Guo Linghong, Li Zhixuan, Wu Shuwei, Jiang Xian
Department of Dermatology, West China Hospital, Sichuan University, Chengdu, China.
Laboratory of Dermatology, Clinical Institute of Inflammation and Immunology, Frontiers Science Center for Disease-Related Molecular Network, West China Hospital, Sichuan University, Chengdu, China.
Pediatr Dermatol. 2023 Sep-Oct;40(5):841-850. doi: 10.1111/pde.15398. Epub 2023 Aug 2.
Dupilumab is the first biologic approved for the treatment of moderate-to-severe atopic dermatitis (AD) in children and adolescents. Previous systematic reviews explored the effectiveness and safety of dupilumab in adults with AD. However, the underlying mechanisms of AD can vary among different age groups, emphasizing the need for separate investigation into the use of dupilumab in children and adolescents with AD.
To evaluate the efficacy and safety of dupilumab in children and adolescents with AD based on evidence from clinical trials and observational studies.
The process of meta-analysis was conducted according to preferred reporting items for systematic reviews and meta-analyses guidelines.
Seven clinical trials and 11 observational studies involving 1275 children and adolescents with AD were eligible for quantitative analysis. Overall, the pooled percentages of eczema area and severity index (EASI) 50, EASI 75, EASI 90, EASI 100, and investigator's global assessment (IGA) 0/1 were 72.9% (95% CI: 61.6%-81.9%), 57.4% (48.1%-66.2%), 31.3% (24.0%-39.7%), 29.7% (23.3%-37.0%), and 35.2% (29.3%-41.5%). With prolonged treatment time, an increase was seen in the pooled rate of EASI response, indicating that dupilumab may provide sustained benefits for children and adolescents over the long term. The reported adverse events were primarily mild and manageable, with an overall incidence rate of 7.2% across clinical trials and 7.6% across observational studies.
Dupilumab was an effective and safe treatment option for children and adolescents with AD, with positive results observed from long-term use and an acceptable safety profile. More long-term, high-quality, controlled studies in different regions are needed for further verification.
度普利尤单抗是首个被批准用于治疗儿童和青少年中重度特应性皮炎（AD）的生物制剂。以往的系统评价探讨了度普利尤单抗在成人AD患者中的有效性和安全性。然而，AD的潜在机制在不同年龄组中可能有所不同，这凸显了对度普利尤单抗在儿童和青少年AD患者中的应用进行单独研究的必要性。
基于临床试验和观察性研究的证据，评估度普利尤单抗在儿童和青少年AD患者中的疗效和安全性。
根据系统评价和Meta分析的首选报告项目指南进行Meta分析。
7项临床试验和11项观察性研究纳入了1275例儿童和青少年AD患者，符合定量分析的条件。总体而言，湿疹面积和严重程度指数（EASI）改善50%、75%、90%、100%以及研究者整体评估（IGA）为0/1的合并百分比分别为72.9%（95%CI：61.6%-81.9%）、57.4%（48.1%-66.2%）、31.3%（24.0%-39.7%）、29.7%（23.3%-37.0%）和35.2%（29.3%-41.5%）。随着治疗时间的延长，EASI反应的合并率有所增加，这表明度普利尤单抗可能为儿童和青少年长期提供持续的益处。报告的不良事件主要为轻度且易于管理，临床试验中的总体发生率为7.2%，观察性研究中的总体发生率为7.6%。
度普利尤单抗是治疗儿童和青少年AD的一种有效且安全的选择，长期使用效果良好且安全性可接受。需要在不同地区开展更多长期、高质量的对照研究以进行进一步验证。
