Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY
Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY
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DOI：
10.1016/j.anai.2020.10.008
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发表时间：
2021-01-25
影响因子：
5.9
通讯作者：
O'Quinn, Sean
中科院分区：
文献类型：
--
作者：
Corren, Jonathan;Garcia Gil, Esther;O'Quinn, Sean
背景资料：重度、不受控制的哮喘患者经常发生急性发作和住院，导致健康相关的生活质量下降。在2b期Pathway研究中（NCT 02054130），与安慰剂相比，tezepelumab使急性发作减少了71%，并改善了肺功能、哮喘控制和健康相关的生活质量。目的：本分析进一步评估了tezepelumab对PATHWAY中患者报告结局（PRO）的影响。患有重度、不受控制的哮喘的成人随机接受皮下注射tezepelumab（70 mg每4周一次，210 mg每4周一次，或280 mg每2周一次）或安慰剂治疗52周。使用哮喘控制问卷-6（ACQ-6）和12岁或以上患者的哮喘生活质量问卷（标准化）（AQLQ[S]+12）评估PRO。确定了tezepelumab组和安慰剂组中缓解者（定义为ACQ-6或AQLQ（S）+12评分改善> 0.5）和哮喘控制良好、部分控制或未控制的患者比例。哮喘每日日记问卷被用来评估整体症状严重程度的变化。高达82%和77%的tezepelumab治疗患者分别为ACQ-6和AQLQ（S）+12应答者，而安慰剂治疗患者分别为70%和64%。tezepelumab治疗组中哮喘控制良好或部分控制的患者比例高于安慰剂组。结论：Tezepelumab治疗与安慰剂相比改善了PRO，如Tezepelumab剂量组中ACQ-6和AQLQ（S）+12应答者比例较高以及症状严重程度改善所示。这些数据进一步支持tezepelumab在重度、不受控制的哮喘患者中的获益。(C)2020年美国过敏，哮喘和免疫学学院。这是一个在CC BY许可证下的开放获取文章（http：//creativecommons.org/licenses/by/4.0/）。
Background: Patients with severe, uncontrolled asthma experience frequent exacerbations and hospitalization, leading to poor health-related quality of life. In the phase 2b PATHWAY study (NCT02054130), tezepelumab reduced exacerbations by up to 71% and improved lung function, asthma control, and health-related quality of life vs placebo.Objective: This analysis further assessed the impact of tezepelumab on patient-reported outcomes (PROs) in PATHWAY.Methods: Adults with severe, uncontrolled asthma were randomized to subcutaneous tezepelumab (70 mg every 4 weeks, 210 mg every 4 weeks, or 280 mg every 2 weeks) or placebo for 52 weeks. PROs were assessed using the asthma control questionnaire-6 (ACQ-6) and the asthma quality of life questionnaire (standardized) for patients aged 12 years or older (AQLQ[S]+12). The proportions of responders (defined by improvements of similar to 0.5 in ACQ-6 or AQLQ(S)+12 scores) and patients whose asthma was well-controlled, partially-controlled, or uncontrolled in the tezepelumab and placebo groups were identified. The Asthma Daily Diary questionnaire was used to assess changes in overall symptom severity.Results: Overall, 550 patients were randomized. Up to 82% and 77% of tezepelumab-treated patients were ACQ-6 and AQLQ(S)+12 responders, respectively, compared with 70% and 64% of placebo-treated patients, respectively. The proportions of patients with well-controlled or partially-controlled asthma were higher in the tezepelumab-treated group than in the placebo group. In addition, tezepelumab improved the overall symptom severity.Conclusion: Tezepelumab treatment improved PROs vs placebo, as indicated by the higher proportion of ACQ-6 and AQLQ(S)+12 responders and improvements in symptom severity in the tezepelumab dose groups. These data further support the benefits of tezepelumab in patients with severe, uncontrolled asthma. (C) 2020 American College of Allergy, Asthma & Immunology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).