杜匹单抗对 6 个月至 11 岁特应性皮炎患儿的疗效:中国的一项回顾性真实世界研究。

IF 4 3区 医学 Q1 DERMATOLOGY Dermatitis Pub Date : 2024-01-01 Epub Date: 2023-02-17 DOI:10.1089/derm.2022.0069
Nali Yang, Yahui Ye, Junyi Shao, Hanwen Wu, Qiuyang Xu, Jilin Zhu, Jingjing Liu, Zhiming Li
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引用次数: 0

摘要

背景:特应性皮炎(AD)是一种影响患者生活质量的常见皮肤病,尤其是在儿童群体中。杜比鲁单抗在治疗青少年和成人特应性皮炎方面显示出良好的疗效和安全性,但使用杜比鲁单抗治疗年幼儿童的真实数据却很少。我们的目标是我们对年龄≥6 个月至 11 岁的中重度 AD 儿童使用杜比鲁单抗的剂量、疗效和安全性进行了调查。方法:这是一项单中心回顾性队列研究:这项单中心回顾性队列分析包括接受过杜比鲁单抗治疗的 12 岁以下重度 AD 患者。主要终点包括第24周(W24)时达到验证研究者总体评估(vIGA)0/1的比例以及湿疹面积和严重程度指数(EASI)和SCORing特应性皮炎(SCORAD)与基线相比的百分比变化。次要终点是治疗第24周后瘙痒数值评分(P-NRS)和体表面积(BSA)的平均变化、不良事件描述以及儿童皮肤病生活质量指数(CDLQI)与基线相比的终点改善情况。结果:共纳入 57 名患者(平均年龄为 7.2 ± 3.0 岁)。57 名患者中有 51 名(89.5%)在治疗第 24 个月时达到了主要终点(vIGA = 0/1)。从基线到W24,接受dupilumab治疗的患者EASI、SCORAD、P-NRS和CDLQI评分均有显著改善,并一直保持到W40。在不同年龄组中,终点 vIGA 均为 0/1:95.2% 的低龄儿童(20/21)和 88.9%的高龄儿童(32/36)。无严重药物不良反应报告。结论这项研究旨在描述杜比鲁单抗在儿童患者中的安全性和有效性,并考察不同剂量的疗效差异。研究结果与现有临床试验结果相当。III期临床试验:NCT03346434。
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Efficacy of Dupilumab in Children 6 Months to 11 Years Old With Atopic Dermatitis: A Retrospective Real-World Study in China.

Background: Atopic dermatitis (AD) is a common skin disease that affects patients' quality of life, especially in the pediatric population. Dupilumab has shown good efficacy and safety in the treatment of AD in adolescents and adults, but the real data on younger children using dupilumab are scarce. Objectives: We investigated the doses, efficacy, and safety of dupilumab in children with moderate-to-severe AD aged ≥6 months to 11 years. Methods: This single-center retrospective cohort analysis included dupilumab-treated patients with severe AD under 12 years of age. Primary endpoints included the proportion of Validated Investigator Global Assessment (vIGA) 0/1 achieved and the percentage change from baseline in eczema area and severity index (EASI) and SCORing Atopic Dermatitis (SCORAD) at week 24 (W24). Secondary endpoints were mean change in pruritus numerical rating score (P-NRS) and body surface area (BSA) after W24 of treatment, description of adverse events, and Children's Dermatology Life Quality Index (CDLQI) improvement from baseline in endpoints. Results: Fifty-seven patients were included (mean age 7.2 ± 3.0 years). The primary endpoint (vIGA = 0/1) was achieved by 51 of 57 (89.5%) patients at W24. Significant improvements in EASI, SCORAD, P-NRS, and CDLQI scores were observed from baseline to W24 with dupilumab treatment and remained until W40. In different age groups, the endpoint vIGA achieved 0/1: 95.2% (20/21) of younger children and 88.9% (32/36) of older children. No serious adverse drug reactions were reported. Conclusions: This study aimed to describe the safety and efficacy of dupilumab in pediatric patients and examined differences of efficacy with various doses. The outcomes are comparable with those of existing clinical trials. Phase III Clinical Trial: NCT03346434.

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来源期刊
Dermatitis
Dermatitis 医学-皮肤病学
CiteScore
5.30
自引率
11.50%
发文量
251
审稿时长
>12 weeks
期刊介绍: Dermatitis is owned by the American Contact Dermatitis Society and is the home journal of 4 other organizations, namely Societa Italiana di Dermatologica Allergologica Professionale e Ambientale, Experimental Contact Dermatitis Research Group, International Contact Dermatitis Research Group, and North American Contact Dermatitis Group. Dermatitis focuses on contact, atopic, occupational, and drug dermatitis, and welcomes manuscript submissions in these fields, with emphasis on reviews, studies, reports, and letters. Annual sections include Contact Allergen of the Year and Contact Allergen Alternatives, for which papers are chosen or invited by the respective section editor. Other sections unique to the journal are Pearls & Zebras, Product Allergen Watch, and news, features, or meeting abstracts from participating organizations.
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