泰泽单抗可恢复重度、未控制哮喘患者的正常肺功能：PATHWAY和NAVIGATOR研究的汇总结果
Tezepelumab can Restore Normal Lung Function in Patients with Severe, Uncontrolled Asthma: Pooled Results from the PATHWAY and NAVIGATOR Studies.
作者信息
Pavord Ian D, Brightling Christopher E, Korn Stephanie, Martin Nicole L, Ponnarambil Sandhia S, Molfino Nestor A, Parnes Jane R, Ambrose Christopher S
机构信息
Respiratory Medicine, National Institute for Health and Care Research Oxford Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Institute for Lung Health, National Institute for Health and Care Research Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.
出版信息
Pulm Ther. 2025 Jun;11(2):315-325. doi: 10.1007/s41030-025-00294-2. Epub 2025 Apr 26.
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 (FEV) of < 80% (< 90% for adolescents in NAVIGATOR) at screening. The change from baseline to week 52 in pre-BD FEV was assessed by baseline percent predicted pre-BD FEV 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 FEV 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.
简介
这项事后分析评估了tezepelumab治疗对基线时肺功能异常的重度、未控制哮喘患者恢复正常肺功能的能力，这些患者数据来自PATHWAY和NAVIGATOR研究。
方法
PATHWAY和NAVIGATOR是多中心、随机、双盲、安慰剂对照研究。纳入该分析的患者（12 - 80岁）每4周皮下注射210 mg tezepelumab或匹配的安慰剂，持续52周。患者在筛查时支气管扩张剂前（BD）1秒用力呼气容积（FEV）预测值百分比<80%（NAVIGATOR研究中的青少年为<90%）。通过基线BD前FEV预测值百分比亚组[异常（<80%）和正常（≥80%）]评估从基线到第52周BD前FEV的变化。总体以及按生物标志物水平和疾病持续时间亚组评估基线时肺功能异常的患者在第52周达到正常肺功能的比例。
结果
分别接受tezepelumab或安慰剂的665例和669例患者中，564例和569例在基线时肺功能异常。与安慰剂相比，tezepelumab使基线时肺功能异常和正常的患者从基线到第52周的BD前FEV分别改善了0.14 L [95%置信区间（CI）0.09 - 0.19]和0.13 L（95% CI 0.01 - 0.24）。基线时肺功能异常的接受tezepelumab治疗的患者在第52周达到正常肺功能的比例高于接受安慰剂治疗的患者（分别为17.2%和9.9%）。在接受tezepelumab治疗的患者中，基线时2型炎症生物标志物水平较高且疾病持续时间较短的患者在第52周更有可能达到正常肺功能。
结论
在重度、未控制哮喘患者中，基线时肺功能异常的接受tezepelumab治疗的患者在第52周达到正常肺功能的比例高于接受安慰剂治疗的患者。
试验注册
PATHWAY：NCT02054130；NAVIGATOR：NCT03347279。
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