P62:来自liberty asthma quest研究的数据显示,dupilumab在不受控制的中度至重度哮喘患者的日常哮喘相关症状中显示出快速和持续的改善

IF 1.8 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL
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引用次数: 0

摘要

Jo Douglass1, David Langton2, Jonathan Corren3, Mario Castro4, Sophie Guillonneau5, Jingdong Chao6, Nikhil Amin6, Neil MH Graham6, Ariel Teper7和Asif khan 71墨尔本健康和墨尔本大学,墨尔本,维多利亚州;半岛健康,墨尔本,维多利亚州;大卫格芬加州大学洛杉矶分校医学院;美国4华盛顿大学医学院,圣路易斯,密苏里州;美国5赛诺菲,Chilly-Mazarin,法国;USA7Sanofi, Bridgewater, NJ, USADupilumab (DPL),一种完全人白细胞介素(IL)-4Rα单抗,抑制IL-4/IL-13信号传导,2型炎症的关键驱动因素。在3期LIBERTY ASTHMA QUEST研究(NCT02414854)中,与匹配的安慰剂(PBO)相比,每2周给药200mg/300mg DPL降低了年化严重恶化率,改善了肺功能,并且在成人和青少年未控制的中度至重度哮喘患者中通常耐受性良好。早在第2周就观察到哮喘控制和生活质量的改善,并持续整个52周的治疗期。这项预先指定的分析评估了DPL对哮喘相关症状的影响。每日用电子日记记录症状;在夜间(上午)和白天(下午)发生的症状按照李克特样量表从0(无哮喘症状)到4(更严重的症状)的5分进行评分。在第2周和第52周评估DPL与PBO的基线症状变化。采用Pearson相关系数评价症状评分与哮喘控制问卷(ACQ-5)、哮喘生活质量问卷(AQLQ)评分的相关性。DPL 200 mg/300 mg与PBO相比,在第2周迅速改善AM (P≤0.05)和PM (P≤0.01)症状评分(表)。在52周的治疗期间,AM/PM症状评分持续改善(P≤0.01)。在第52周,观察到PBO组和DPL组AM/PM症状评分的变化与ACQ-5/AQLQ评分的变化之间存在中度相关性。DPL组最常见的不良事件是注射部位反应(15%和18%;与安慰剂相比,分别为5%和10%)。附加杜匹单抗可迅速改善青少年和成人不受控制的中度至重度哮喘的早晨和夜间哮喘症状。在52周的治疗期间,症状评分保持改善,并与哮喘控制和生活质量的改善中度相关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
P62: DUPILUMAB DEMONSTRATES RAPID AND SUSTAINED IMPROVEMENTS IN DAILY ASTHMA-RELATED SYMPTOMS IN PATIENTS WITH UNCONTROLLED, MODERATE-TO-SEVERE ASTHMA: DATA FROM THE LIBERTY ASTHMA QUEST STUDY

Jo Douglass1, David Langton2, Jonathan Corren3, Mario Castro4, Sophie Guillonneau5, Jingdong Chao6, Nikhil Amin6, Neil MH Graham6, Ariel Teper7 and Asif Khan7

1Melbourne Health and the University of Melbourne, Melbourne, Victoria, Australia

2Peninsula Health, Melbourne, Victoria, Australia

3David Geffen School of Medicine at UCLA, Los Angeles, CA, USA

4Washington University School of Medicine, Saint Louis, MO, USA

5Sanofi, Chilly-Mazarin, France

6Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA

7Sanofi, Bridgewater, NJ, USA

Dupilumab (DPL), a fully human interleukin (IL)-4Rα mAb, inhibits IL-4/IL-13 signalling, key drivers of Type 2 inflammation. In the phase 3 LIBERTY ASTHMA QUEST study (NCT02414854), DPL 200mg/300mg administered every 2 weeks versus matched placebo (PBO) reduced annualized severe exacerbation rates, improved lung function, and was generally well tolerated in adults and adolescents with uncontrolled, moderate-to-severe asthma. Improvements in asthma control and quality of life were observed as early as Week 2 and sustained throughout the 52-week treatment period. This pre-specified analysis evaluates DPL's effect on asthma-related symptoms.

Symptoms were recorded daily by electronic diary; symptoms occurring during the night (AM) and day (PM) were scored on a 5-point Likert-like scale from 0 (no asthma symptoms) to 4 (more severe symptoms). Changes from baseline in symptoms at Weeks 2 and 52 were assessed for DPL versus PBO. Correlations between symptom scores and 5-item Asthma Control Questionnaire (ACQ-5) and Asthma Quality of Life Questionnaire (AQLQ) scores were assessed by Pearson's correlation coefficient.

DPL 200 mg/300 mg rapidly improved AM (P≤0.05) and PM (P ≤ 0.01) symptom scores versus PBO at Week 2 (Table). AM/PM symptom scores continued to improve throughout the 52-week treatment period (P ≤ 0.01). At Week 52, moderate correlations were observed between change in AM/PM symptom scores and change in ACQ-5/AQLQ scores in the PBO and DPL groups. The most frequent adverse event in the DPL group was injection site reactions (15% and 18%; versus placebo, 5% and 10%, respectively).

Add-on dupilumab rapidly improves morning and evening asthma symptoms in adolescents and adults with uncontrolled, moderate-to-severe asthma. Improvements in symptom scores were maintained during the 52 weeks’ treatment and moderately correlated with improvements in asthma control and quality of life.

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来源期刊
Internal Medicine Journal
Internal Medicine Journal 医学-医学:内科
CiteScore
3.50
自引率
4.80%
发文量
600
审稿时长
3-6 weeks
期刊介绍: The Internal Medicine Journal is the official journal of the Adult Medicine Division of The Royal Australasian College of Physicians (RACP). Its purpose is to publish high-quality internationally competitive peer-reviewed original medical research, both laboratory and clinical, relating to the study and research of human disease. Papers will be considered from all areas of medical practice and science. The Journal also has a major role in continuing medical education and publishes review articles relevant to physician education.
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