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度普利尤单抗治疗成人、青少年及6岁及以上儿童特应性皮炎的3期试验综述

A Review of Phase 3 Trials of Dupilumab for the Treatment of Atopic Dermatitis in Adults, Adolescents, and Children Aged 6 and Up.

作者信息

Cather Jennifer, Young Melodie, DiRuggiero Douglas C, Tofte Susan, Williams Linda, Gonzalez Tayler

机构信息

Mindful Dermatology and Modern Research Associates, Dallas, TX, USA.

Skin Cancer and Cosmetic Dermatology Center, Rome, GA, USA.

出版信息

Dermatol Ther (Heidelb). 2022 Sep;12(9):2013-2038. doi: 10.1007/s13555-022-00778-y. Epub 2022 Aug 26.

DOI:10.1007/s13555-022-00778-y
PMID:36028787
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9464283/
Abstract

Atopic dermatitis (AD) is a chronic pruritic skin disease that can have a profound negative impact on patients' quality of life, especially in cases of inadequate disease control. Dupilumab, a dual inhibitor of IL-4 and IL-13 signaling, is approved in the United States for the treatment of moderate-to-severe AD in adults (≥ 18 years old) and in children (≥ 6 years old). In this review, we present results from phase 3 trials evaluating dupilumab's efficacy and safety in adults, adolescents, and children. These trials demonstrate that dupilumab provides rapid improvements (in as little as 1 week) and sustained efficacy (up to 4 years) when used as a treatment for moderate-to-severe AD. Dupilumab not only improves skin signs and symptoms, but also provides multiple health benefits beyond the skin, including improvements in quality of life, itch, sleep disturbances, and pain/discomfort. Dupilumab is generally well tolerated, has a favorable safety profile in adults, adolescents, and children, has no serious drug-drug interactions, does not require routine laboratory testing, and is not an immunosuppressant. Taken together, phase 3 trials demonstrate that dupilumab provides rapid and sustained efficacy and is generally well tolerated for the treatment of moderate-to-severe AD across age groups.

摘要

特应性皮炎(AD)是一种慢性瘙痒性皮肤病,会对患者的生活质量产生严重负面影响,尤其是在疾病控制不佳的情况下。度普利尤单抗是一种白细胞介素-4(IL-4)和白细胞介素-13(IL-13)信号通路的双重抑制剂,在美国被批准用于治疗成人(≥18岁)和儿童(≥6岁)的中重度AD。在本综述中,我们展示了评估度普利尤单抗在成人、青少年和儿童中的疗效和安全性的3期试验结果。这些试验表明,度普利尤单抗作为中重度AD的治疗药物,能迅速改善症状(短至1周)并持续有效(长达4年)。度普利尤单抗不仅能改善皮肤症状和体征,还能在皮肤之外带来多种健康益处,包括改善生活质量、瘙痒、睡眠障碍以及疼痛/不适。度普利尤单抗一般耐受性良好,在成人、青少年和儿童中具有良好的安全性,没有严重的药物相互作用,无需常规实验室检查,也不是免疫抑制剂。综上所述,3期试验表明,度普利尤单抗能迅速且持续地发挥疗效,在各年龄组中治疗中重度AD时一般耐受性良好。

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本文引用的文献

1
Preclinical and clinical experience with dupilumab on the correlates of live attenuated vaccines.度普利尤单抗在减毒活疫苗相关性方面的临床前和临床经验。
J Allergy Clin Immunol Glob. 2021 Dec 8;1(1):9-15. doi: 10.1016/j.jacig.2021.12.003. eCollection 2022 Feb.
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Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis.在一项开放性研究中,度普利尤单抗为中重度特应性皮炎成人患者提供了长达 4 年的可接受安全性和持续疗效。
Am J Clin Dermatol. 2022 May;23(3):393-408. doi: 10.1007/s40257-022-00685-0. Epub 2022 May 3.
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Infections in children and adolescents treated with dupilumab in pediatric clinical trials for atopic dermatitis-A pooled analysis of trial data.
度普利尤单抗在6个月及以上中国儿科患者中的安全性:一项前瞻性真实世界研究。
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The cardiometabolic safety of dupilumab in atopic dermatitis: A global large-scale cohort study.度普利尤单抗在特应性皮炎中的心脏代谢安全性:一项全球大规模队列研究。
Arch Dermatol Res. 2025 Jan 20;317(1):296. doi: 10.1007/s00403-024-03601-0.
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Dupilumab and neuropsychiatric outcomes in pediatric atopic dermatitis: A real-world cohort analysis.度普利尤单抗与儿童特应性皮炎的神经精神结局:一项真实世界队列分析。
J Am Acad Dermatol. 2025 May;92(5):1126-1128. doi: 10.1016/j.jaad.2025.01.027. Epub 2025 Jan 19.
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A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities.一项关于度普利尤单抗治疗特应性皮炎患者的真实世界研究,其中包括患有恶性肿瘤和其他内科合并症的患者。
JAAD Int. 2024 Jan 17;15:5-11. doi: 10.1016/j.jdin.2024.01.002. eCollection 2024 Jun.
在治疗特应性皮炎的儿科临床试验中接受度普利尤单抗治疗的儿童和青少年的感染——试验数据的汇总分析
Pediatr Dermatol. 2022 Mar;39(2):187-196. doi: 10.1111/pde.14909. Epub 2022 Jan 26.
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Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial.6-11 岁重度特应性皮炎患者度普利尤单抗的实验室安全性:III 期临床试验结果。
Paediatr Drugs. 2021 Sep;23(5):515-527. doi: 10.1007/s40272-021-00459-x. Epub 2021 Aug 31.
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Effect of Dupilumab on Laboratory Parameters in Adolescents with Atopic Dermatitis: Results from a Randomized, Placebo-Controlled, Phase 3 Clinical Trial.度普利尤单抗对青少年特应性皮炎患者实验室参数的影响:一项随机、安慰剂对照、3 期临床试验结果。
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Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study.在患有中重度特应性皮炎的成年人中,dupilumab 长达 3 年的实验室安全性:来自开放标签扩展研究的结果。
J Dermatolog Treat. 2022 May;33(3):1608-1616. doi: 10.1080/09546634.2020.1871463. Epub 2021 Feb 8.
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Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma.青少年特应性皮炎或哮喘患者接受度普利尤单抗临床试验中的结膜炎。
Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1.
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Dupilumab provides favourable long-term safety and efficacy in children aged ≥ 6 to < 12 years with uncontrolled severe atopic dermatitis: results from an open-label phase IIa study and subsequent phase III open-label extension study.度普利尤单抗在 6 岁至<12 岁未得到控制的重度特应性皮炎儿童中提供了良好的长期安全性和疗效:来自开放标签 IIa 期研究和随后的 III 期开放标签扩展研究的结果。
Br J Dermatol. 2021 May;184(5):857-870. doi: 10.1111/bjd.19460. Epub 2020 Oct 9.
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Dupilumab significantly improves sleep outcomes in adult patients with atopic dermatitis: results from five randomized clinical trials.
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Real-world persistence with dupilumab among adults with atopic dermatitis.真实世界中成人特应性皮炎患者使用度普利尤单抗的持续性。
Ann Allergy Asthma Immunol. 2021 Jan;126(1):40-45. doi: 10.1016/j.anai.2020.07.026. Epub 2020 Jul 31.