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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.

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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