Tezepelumab可以恢复严重、未控制哮喘患者的正常肺功能：来自PATHWAY和NAVIGATOR研究的汇总结果
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引用次数: 0
摘要
本事后分析评估了tezepelumab治疗在PATHWAY和NAVIGATOR研究中收集的基线肺功能异常的严重、不受控制的哮喘患者恢复正常肺功能的能力。方法：PATHWAY和NAVIGATOR为多中心、随机、双盲、安慰剂对照研究。纳入该分析的患者（12-80岁）每4周接受tezepelumab 210 mg皮下注射或匹配安慰剂52周。患者预测支气管扩张剂前（BD） 1秒内用力呼气量（FEV1）为1，基线预测bd1前FEV1亚组异常(结果：分别接受tezepelumab或安慰剂治疗的665和669例患者中，564和569例患者在基线时肺功能异常。与安慰剂相比，Tezepelumab在基线时肺功能异常和正常的患者中，从基线到第52周的bd前FEV1比安慰剂分别提高了0.14 L[95%可信区间（CI） 0.09-0.19]和0.13 L （95% CI 0.01-0.24）。基线时肺功能异常的tezepelumab患者在第52周达到正常肺功能的比例高于安慰剂患者（分别为17.2%和9.9%）。在接受tezepelumab治疗的患者中，那些2型炎症生物标志物水平较高且基线时疾病持续时间较短的患者更有可能在第52周达到正常的肺功能。结论：在严重、未控制的哮喘患者中，与基线时肺功能异常的安慰剂患者相比，tezepelumab患者在52周时肺功能恢复正常的比例更高。试验注册：PATHWAY: NCT02054130；导航器:NCT03347279。本文章由计算机程序翻译，如有差异，请以英文原文为准。
Tezepelumab can Restore Normal Lung Function in Patients with Severe, Uncontrolled Asthma: Pooled Results from the PATHWAY and NAVIGATOR Studies.
Introduction: This post hoc analysis assessed the ability of tezepelumab treatment to restore normal lung function in patients with severe, uncontrolled asthma with abnormal lung function at baseline pooled from the PATHWAY and NAVIGATOR studies.
Methods: PATHWAY and NAVIGATOR were multicentre, randomized, double-blind, placebo-controlled studies. Patients (12-80 years old) included in this analysis received tezepelumab 210 mg subcutaneously every 4 weeks or matched placebo for 52 weeks. Patients had a percent predicted pre-bronchodilator (BD) forced expiratory volume in 1 s (FEV1) of < 80% (< 90% for adolescents in NAVIGATOR) at screening. The change from baseline to week 52 in pre-BD FEV1 was assessed by baseline percent predicted pre-BD FEV1 subgroup [abnormal (< 80%) and normal (≥ 80%)]. The proportion of patients with abnormal lung function at baseline who achieved normal lung function at week 52 was assessed overall and by biomarker level and disease duration subgroups.
Results: Of the 665 and 669 patients who received tezepelumab or placebo, respectively, 564 and 569 had abnormal lung function at baseline. Tezepelumab improved the pre-BD FEV1 from baseline to week 52 versus placebo by 0.14 L [95% confidence interval (CI) 0.09-0.19] and 0.13 L (95% CI 0.01-0.24) in patients with abnormal and normal lung function at baseline, respectively. A higher proportion of tezepelumab than placebo recipients with abnormal lung function at baseline achieved normal lung function at week 52 (17.2% vs. 9.9%, respectively). Among tezepelumab recipients, those with higher levels of type 2 inflammatory biomarkers and a shorter duration of disease at baseline were more likely to achieve normal lung function at week 52.
Conclusion: In patients with severe, uncontrolled asthma, a greater proportion of tezepelumab than placebo recipients with abnormal lung function at baseline achieved normal lung function at week 52.
Trial registration: PATHWAY: NCT02054130; NAVIGATOR: NCT03347279.
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来源期刊
Pulmonary Therapy
Medicine-Pulmonary and Respiratory Medicine
CiteScore
5.20
自引率
3.30%
发文量
24
审稿时长
6 weeks
期刊介绍：
Aims and Scope
Pulmonary Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the use of pulmonary therapies, devices, and surgical techniques.
Areas of focus include, but are not limited to: asthma; chronic obstructive pulmonary disease; idiopathic pulmonary fibrosis; pulmonary hypertension; cystic fibrosis; lung cancer; respiratory tract disorders; allergic rhinitis and other respiratory allergies; influenza, pneumococcal infection, respiratory syncytial virus and other respiratory infections; and inhalers and other device therapies.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Pulmonary 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 quality research, which may be considered of insufficient interest by other journals.
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The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of pulmonary therapies.
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