Mark Boguniewicz, Lawrence D. Sher, Amy S. Paller, Peter D. Arkwright, Shigemi Yoshihara, Zhen Chen, Parul Shah, Ainara Rodríguez Marco
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In this post hoc analysis, patients were stratified by the presence or absence of caregiver-reported selected type 2 comorbidities at baseline: asthma, allergic rhinitis (AR), and food allergies (FAs).</p><h3>Results</h3><p>At week 16, significantly more patients receiving dupilumab versus placebo, with or without asthma and AR, achieved an Investigator’s Global Assessment (IGA) score of 0/1 and a ≥ 75% improvement in Eczema Area and Severity Index (all <i>p</i> < 0.05). Significantly more patients receiving dupilumab versus placebo with FAs and numerically more patients without FAs achieved an IGA score of 0/1 (<i>p</i> = 0.0007 and <i>p</i> = 0.06). Numerically more patients receiving dupilumab versus placebo with asthma and significantly more patients without asthma achieved a ≥ 4-point reduction in the weekly average of daily score on the Worst Scratch/Itch Numeric Rating Scale (WSI-NRS) (<i>p</i> = 0.6 and <i>p</i> < 0.0001). Additionally, significantly more patients receiving dupilumab versus placebo with or without AR (<i>p</i> = 0.008 and <i>p</i> < 0.0001) and with or without FAs (<i>p</i> = 0.0002 and <i>p</i> = 0.004) achieved a ≥ 4-point reduction in the weekly average of daily score on the WSI-NRS. Overall safety was consistent with the known dupilumab safety profile.</p><h3>Conclusions</h3><p>Dupilumab treatment improves AD signs and symptoms in children aged 6 months to 5 years with and without type 2 comorbidities such as asthma, AR, and FAs.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov registration number NCT03346434.</p><h3>Infographic</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div>\n<div><div><div></div></div><div><p>Do type 2 comorbidities impact the response to dupilumab in children with atopic dermatitis? 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引用次数: 0
摘要
简介：特应性皮炎（AD）患者通常合并其他2型炎症。本研究旨在评估2型并发症对AD幼童对杜必鲁单抗的反应和安全性的影响：LIBERTY AD PRESCHOOL B 部分是一项随机、安慰剂对照试验，对象是 6 个月至 5 岁的中重度 AD 儿童。在这项事后分析中，根据护理人员报告的基线2型合并症（哮喘、过敏性鼻炎（AR）和食物过敏（FAs））的存在与否对患者进行了分层：结果：第16周时，与安慰剂相比，无论是否患有哮喘和过敏性鼻炎，接受杜匹单抗治疗的患者中达到研究者总体评估（IGA）0/1分以及湿疹面积和严重程度指数改善≥75%的患者明显增多（所有P均为0）：杜比鲁单抗能改善6个月至5岁患有或不患有哮喘、AR和FAs等2型合并症的儿童的AD症状和体征：试验注册：ClinicalTrials.gov 注册号 NCT03346434.Infographic：2型合并症会影响特应性皮炎患儿对杜匹单抗的反应吗？(mp4 103,451 kb）。
Dupilumab is Efficacious in Young Children with Atopic Dermatitis Regardless of Type 2 Comorbidities
Introduction
Patients with atopic dermatitis (AD) often have other comorbid type 2 inflammatory conditions. The aim of this study was to evaluate the impact of type 2 comorbidities on the response to and safety of dupilumab in young children with AD.
Methods
LIBERTY AD PRESCHOOL part B was a randomized, placebo-controlled trial in children aged 6 months to 5 years with moderate-to-severe AD. In this post hoc analysis, patients were stratified by the presence or absence of caregiver-reported selected type 2 comorbidities at baseline: asthma, allergic rhinitis (AR), and food allergies (FAs).
Results
At week 16, significantly more patients receiving dupilumab versus placebo, with or without asthma and AR, achieved an Investigator’s Global Assessment (IGA) score of 0/1 and a ≥ 75% improvement in Eczema Area and Severity Index (all p < 0.05). Significantly more patients receiving dupilumab versus placebo with FAs and numerically more patients without FAs achieved an IGA score of 0/1 (p = 0.0007 and p = 0.06). Numerically more patients receiving dupilumab versus placebo with asthma and significantly more patients without asthma achieved a ≥ 4-point reduction in the weekly average of daily score on the Worst Scratch/Itch Numeric Rating Scale (WSI-NRS) (p = 0.6 and p < 0.0001). Additionally, significantly more patients receiving dupilumab versus placebo with or without AR (p = 0.008 and p < 0.0001) and with or without FAs (p = 0.0002 and p = 0.004) achieved a ≥ 4-point reduction in the weekly average of daily score on the WSI-NRS. Overall safety was consistent with the known dupilumab safety profile.
Conclusions
Dupilumab treatment improves AD signs and symptoms in children aged 6 months to 5 years with and without type 2 comorbidities such as asthma, AR, and FAs.
Trial Registration
ClinicalTrials.gov registration number NCT03346434.
Infographic
Do type 2 comorbidities impact the response to dupilumab in children with atopic dermatitis? (MP4 103,451 KB)
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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