生物制剂药物对儿童或青少年特应性皮炎患者的安全性和疗效:随机对照试验的系统回顾和荟萃分析。

IF 2.2 4区 医学 Q2 DERMATOLOGY
Ana Clara Felix de Farias Santos, Fernanda Valeriano Zamora MD, Lorhayne Kerly Capuchinho Scalioni Galvao MD, Nicole dos Santos Pimenta, João Pedro Costa Esteves Almuinha Salles, Kélen Klein Heffel MD
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引用次数: 0

摘要

患有中度至重度特应性皮炎(AD)的儿童和青少年面临着巨大的疾病负担,极大地影响了他们的生活质量。目前,特应性皮炎的治疗方案十分有限。为了评估生物药物杜匹单抗、来布利珠单抗或曲妥珠单抗在改善中度至重度未得到充分控制的特应性皮炎患者预后方面的安全性和有效性。我们在 PubMed、Embase 和 Cochrane 数据库中检索了在 AD 患者中比较 dupilumab、lebrikizumab 或 tralokinumab 与安慰剂的随机对照试验 (RCT)。我们计算了二元终点的几率比(OR)及95%置信区间(CI),采用随机效应模型,P值为
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and efficacy of biologic drugs in children or adolescents with atopic dermatitis: A systematic review and meta-analysis of randomized controlled trials

Children and adolescents suffering from moderate-to-severe atopic dermatitis (AD) face a significant disease burden that greatly impacts their quality of life. Treatment options for AD are currently limited. To assess the safety and efficacy of biologic drugs, dupilumab, lebrikizumab, or tralokinumab, in improving outcomes in patients with moderate to severe inadequately controlled AD. We searched PubMed, Embase and Cochrane databases for randomized controlled trials (RCTs) comparing dupilumab, lebrikizumab or tralokinumab to placebo in patients with AD. We computed odds ratios (ORs) for binary endpoints, with 95% confidence intervals (CIs), random effects model was used and a p-value <0.05 was considered as statistically significant. We analysed data into Review Manager 5.4. A total of five RCTs and 973 patients were included, of whom 592 were prescribed a biologic drug. Compared with placebo, patients receiving a biologic drug had a greater improvement, achieved an Investigator Global Assessment (IGA) score of 0 or 1 (OR 5.05; 95% CI 3.08–8.29), Eczema Area and Severity Index (EASI) 75 (OR 6.87; 95% CI 4.71–10.02), EASI 50 (OR 8.89; 95% CI 6.18–12.78) and EASI 90 (8.30; 95% CI 4.81–14.31). The proportion of patients with 3 points or more (OR 6.56; 95% CI 4.34–9.90) or 4 points or more (OR 8.09; 95% CI 5.19–12.59) improvement from baseline in peak pruritus NRS was significantly higher with biologic drugs than placebo. There were no significant differences between groups regarding adverse events (OR 0.79; 95% CI 0.58–1.07), and conjunctivitis (OR 2.08; 95% CI 1.00–4.33). In this meta-analysis, dupilumab, lebrikizumab, and tralokinumab have shown significant improvements in signs, symptoms and quality of life in children or adolescents with moderate to severe AD. Larger studies may be needed to continue evaluating the safety and efficacy of these biologic drugs in this patient population.

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来源期刊
CiteScore
3.20
自引率
5.00%
发文量
186
审稿时长
6-12 weeks
期刊介绍: Australasian Journal of Dermatology is the official journal of the Australasian College of Dermatologists and the New Zealand Dermatological Society, publishing peer-reviewed, original research articles, reviews and case reports dealing with all aspects of clinical practice and research in dermatology. Clinical presentations, medical and physical therapies and investigations, including dermatopathology and mycology, are covered. Short articles may be published under the headings ‘Signs, Syndromes and Diagnoses’, ‘Dermatopathology Presentation’, ‘Vignettes in Contact Dermatology’, ‘Surgery Corner’ or ‘Letters to the Editor’.
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