Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study

医学 哮喘 呼出气一氧化氮 安慰剂 嗜酸性粒细胞 内科学 过敏 置信区间 恶化 随机对照试验 奥马佐单抗 空气过敏原 欧洲联盟 免疫学 支气管收缩 免疫球蛋白E 过敏原 病理 替代医学 抗体 业务 经济政策
作者
Jonathan Corren,Christopher S. Ambrose,Janet M. Griffiths,Åsa Hellqvist,Andrew Lindsley,Jean‐Pierre Llanos,Gene Colice,Andrew Menzies‐Gow
出处
期刊:Clinical & Experimental Allergy [Wiley]
卷期号:53 (4): 417-428 被引量:18
标识
DOI:10.1111/cea.14256
摘要

Abstract Background Allergic asthma is the most common phenotype among patients with severe asthma. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) versus placebo in patients with severe, uncontrolled asthma. This exploratory analysis evaluated the efficacy of tezepelumab in NAVIGATOR participants with evidence of severe allergic asthma. Methods Patients (12–80 years old) receiving medium‐ or high‐dose inhaled corticosteroids and ≥ 1 additional controller medication, with or without oral corticosteroids, were randomized to tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks in NAVIGATOR. In this analysis, the AAER, forced expiratory volume in 1 second (FEV 1 ), patient‐reported outcomes (PROs), and type 2 biomarker levels were evaluated in patients grouped by sensitivity to perennial aeroallergens, confirmed symptomatic allergy, and eligibility for omalizumab treatment according to the United States (OMA‐US) and the European Union (OMA‐EU) prescribing information, including subgroups according to baseline blood eosinophil counts and fractional exhaled nitric oxide (FeNO) levels. Results Of 1059 patients who received treatment in NAVIGATOR, 680 (64%) had perennial aeroallergen sensitivity and 318 (30%) had confirmed symptomatic allergy; 379 (36%) and 359 (34%) patients were OMA‐US‐ and OMA‐EU‐eligible, respectively. Tezepelumab reduced the AAER over 52 weeks versus placebo by 58% (95% confidence interval [CI]: 47–67) to 68% (95% CI: 55–77) across these subgroups. Among omalizumab‐eligible patients, AAERs were reduced in patients across baseline blood eosinophil counts and FeNO levels. Tezepelumab improved FEV 1 and PROs, and reduced type 2 biomarkers, versus placebo in patients with and without perennial allergy. Conclusions Tezepelumab was efficacious in patients with severe, uncontrolled asthma with evidence of allergic inflammation, defined by multiple clinically relevant definitions. These findings further support the benefits of tezepelumab in a broad population of patients with severe asthma, including those with severe allergic asthma.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
biubiu完成签到,获得积分10
刚刚
bjglp完成签到,获得积分10
刚刚
微风完成签到,获得积分10
刚刚
三只眼小怪兽完成签到,获得积分10
1秒前
AJ完成签到 ,获得积分10
3秒前
蒲公英完成签到 ,获得积分10
3秒前
勤劳绿毛龟完成签到,获得积分10
3秒前
雷欧奥特曼完成签到,获得积分10
3秒前
hq完成签到,获得积分10
3秒前
gao完成签到 ,获得积分0
3秒前
hunajx完成签到,获得积分10
3秒前
开心的若烟完成签到,获得积分10
4秒前
来自三百发布了新的文献求助10
4秒前
研友_LMpo68完成签到 ,获得积分10
4秒前
好的昂完成签到,获得积分10
5秒前
Ygy完成签到,获得积分10
5秒前
fann完成签到 ,获得积分10
5秒前
梨梨完成签到,获得积分10
6秒前
auraLyV完成签到,获得积分10
7秒前
科研通AI5应助子车谷波采纳,获得10
8秒前
鹏N完成签到,获得积分10
9秒前
文心同学完成签到,获得积分0
9秒前
zp6666tql完成签到 ,获得积分10
9秒前
断水断粮的科研民工完成签到,获得积分10
9秒前
ff0110完成签到,获得积分10
9秒前
彭于晏应助勤劳绿毛龟采纳,获得10
9秒前
orixero应助勤劳绿毛龟采纳,获得10
10秒前
哈喽完成签到,获得积分10
10秒前
唐唐完成签到 ,获得积分10
11秒前
皓月星辰完成签到,获得积分10
12秒前
鹿叽叽完成签到,获得积分10
12秒前
佳佳应助JIE采纳,获得10
13秒前
xiangzq完成签到,获得积分10
15秒前
胖宏完成签到 ,获得积分10
16秒前
拼搏尔风完成签到,获得积分10
16秒前
顾闭月完成签到,获得积分10
17秒前
biofresh完成签到,获得积分10
19秒前
牛姐完成签到,获得积分10
19秒前
lyan完成签到,获得积分10
20秒前
呆萌滑板完成签到 ,获得积分10
21秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
Cognitive Neuroscience: The Biology of the Mind 1000
Technical Brochure TB 814: LPIT applications in HV gas insulated switchgear 1000
Immigrant Incorporation in East Asian Democracies 600
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
A Preliminary Study on Correlation Between Independent Components of Facial Thermal Images and Subjective Assessment of Chronic Stress 500
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3968593
求助须知:如何正确求助?哪些是违规求助? 3513416
关于积分的说明 11167791
捐赠科研通 3248853
什么是DOI,文献DOI怎么找? 1794507
邀请新用户注册赠送积分活动 875170
科研通“疑难数据库(出版商)”最低求助积分说明 804671