Dupilumab 诱导 2 型哮喘患者的长期治疗临床缓解
2025/03/03
摘要
背景：缓解被认为是严重哮喘患者的多组分结果。
目的：这项对 QUEST （NCT02414854） 和 TRAVERSE （NCT02134028） 的事后分析评估了 dupilumab 治疗是否会导致临床哮喘缓解（≥12 个月无严重恶化、口服皮质类固醇使用为零、肺功能稳定或改善、患者报告的哮喘控制 <1.5） 并评估其在不受控制的中度至重度 2 型哮喘（血嗜酸性粒细胞 ≥150 个细胞/μL 或呼出气一氧化氮分数≥父母研究基线时为 20 ppb）的患者的持久性，这些哮喘患者不是接受维持性口服皮质类固醇。
方法：在QUEST中，患者（年龄≥12岁）每2周随机接受dupilumab 200/300 mg或安慰剂治疗52周。在TRAVERSE中，所有患者每2周接受dupilumab 300 mg，持续96周。我们评估了在48周内达到治疗临床缓解标准的患者比例。
结果：在QUEST基线时，1040名接受dupilumab治疗的患者和544名服用安慰剂的患者患有2型哮喘；其中842名（dupilumab/dupilumab）和437名（安慰剂/dupilumab）参加了TRAVERSE。在QUEST第52周（第1年），接受dupilumab治疗的患者中有37.2%符合临床缓解标准，而服用安慰剂的患者为22.2%（均P<0.001）。在TRAVERSE的第48周（总体第2年），42.8%（dupilumab/dupilumab）和33.4%（安慰剂/dupilumab）的患者符合临床缓解标准。总体而言，dupilumab/dupilumab组中29.5%的患者在第1年和第2年都符合标准。
结论：Dupilumab治疗使大约三分之一的2型哮喘患者达到治疗临床哮喘缓解的多组分终点长达2年。
背景：缓解被认为是严重哮喘患者的多组分结果。
目的：这项对 QUEST （NCT02414854） 和 TRAVERSE （NCT02134028） 的事后分析评估了 dupilumab 治疗是否会导致临床哮喘缓解（≥12 个月无严重恶化、口服皮质类固醇使用为零、肺功能稳定或改善、患者报告的哮喘控制 <1.5） 并评估其在不受控制的中度至重度 2 型哮喘（血嗜酸性粒细胞 ≥150 个细胞/μL 或呼出气一氧化氮分数≥父母研究基线时为 20 ppb）的患者的持久性，这些哮喘患者不是接受维持性口服皮质类固醇。
方法：在QUEST中，患者（年龄≥12岁）每2周随机接受dupilumab 200/300 mg或安慰剂治疗52周。在TRAVERSE中，所有患者每2周接受dupilumab 300 mg，持续96周。我们评估了在48周内达到治疗临床缓解标准的患者比例。
结果：在QUEST基线时，1040名接受dupilumab治疗的患者和544名服用安慰剂的患者患有2型哮喘；其中842名（dupilumab/dupilumab）和437名（安慰剂/dupilumab）参加了TRAVERSE。在QUEST第52周（第1年），接受dupilumab治疗的患者中有37.2%符合临床缓解标准，而服用安慰剂的患者为22.2%（均P<0.001）。在TRAVERSE的第48周（总体第2年），42.8%（dupilumab/dupilumab）和33.4%（安慰剂/dupilumab）的患者符合临床缓解标准。总体而言，dupilumab/dupilumab组中29.5%的患者在第1年和第2年都符合标准。
结论：Dupilumab治疗使大约三分之一的2型哮喘患者达到治疗临床哮喘缓解的多组分终点长达2年。
（中日友好医院呼吸与危重症医学科 万静萱 摘译 林江涛 审校）
（J Allergy Clin Immunol Pract 2025 Jan;13(1):132-142; DOI:10.1016/j.jaip.2024.10.009.IF：7.574.）
Dupilumab Induces Long-Term On-Treatment Clinical Remission in Patients With Type 2 Asthma.
Ian D, Pavord; Klaus F, Rabe;
Abstrast
Background: Remission is proposed as a multicomponent outcome for patients with severe asthma.
Objective: This post hoc analysis of QUEST (NCT02414854) and TRAVERSE (NCT02134028) evaluated whether dupilumab treatment leads to clinical asthma remission (≥12 months with no severe exacerbations, zero oral corticosteroid use, stabilized or improved lung function, patient-reported asthma control <1.5) and assessed its durability in patients with uncontrolled, moderate to severe type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide ≥20 ppb at parent-study baseline) who are not receiving maintenance oral corticosteroids.
Methods: In QUEST, patients (aged ≥12 years) were randomized to dupilumab 200/300 mg or placebo every 2 weeks for 52 weeks. In TRAVERSE, all patients received dupilumab 300 mg every 2 weeks for up to 96 weeks. We assessed the proportion of patients meeting criteria for on-treatment clinical remission up to 48 weeks of TRAVERSE.
Results：At QUEST baseline, 1,040 patients receiving dupilumab and 544 taking placebo had type 2 asthma; of those, 842 (dupilumab/dupilumab) and 437 (placebo/dupilumab) enrolled in TRAVERSE. At QUEST week 52 (year 1), 37.2% of patients receiving dupilumab met clinical remission criteria, compared with 22.2% taking placebo (all P < .001). At week 48 of TRAVERSE (year 2 overall), 42.8% (dupilumab/dupilumab) and 33.4% (placebo/dupilumab) of patients met clinical remission criteria. Overall, 29.5% of patients in the dupilumab/dupilumab group met the criteria at both years 1 and 2.
Conclusions: Dupilumab treatment enabled approximately one third of patients with type 2 asthma to meet the multicomponent end point for on-treatment clinical asthma remission for up to 2 years.
Ian D, Pavord; Klaus F, Rabe;
Abstrast
Background: Remission is proposed as a multicomponent outcome for patients with severe asthma.
Objective: This post hoc analysis of QUEST (NCT02414854) and TRAVERSE (NCT02134028) evaluated whether dupilumab treatment leads to clinical asthma remission (≥12 months with no severe exacerbations, zero oral corticosteroid use, stabilized or improved lung function, patient-reported asthma control <1.5) and assessed its durability in patients with uncontrolled, moderate to severe type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide ≥20 ppb at parent-study baseline) who are not receiving maintenance oral corticosteroids.
Methods: In QUEST, patients (aged ≥12 years) were randomized to dupilumab 200/300 mg or placebo every 2 weeks for 52 weeks. In TRAVERSE, all patients received dupilumab 300 mg every 2 weeks for up to 96 weeks. We assessed the proportion of patients meeting criteria for on-treatment clinical remission up to 48 weeks of TRAVERSE.
Results：At QUEST baseline, 1,040 patients receiving dupilumab and 544 taking placebo had type 2 asthma; of those, 842 (dupilumab/dupilumab) and 437 (placebo/dupilumab) enrolled in TRAVERSE. At QUEST week 52 (year 1), 37.2% of patients receiving dupilumab met clinical remission criteria, compared with 22.2% taking placebo (all P < .001). At week 48 of TRAVERSE (year 2 overall), 42.8% (dupilumab/dupilumab) and 33.4% (placebo/dupilumab) of patients met clinical remission criteria. Overall, 29.5% of patients in the dupilumab/dupilumab group met the criteria at both years 1 and 2.
Conclusions: Dupilumab treatment enabled approximately one third of patients with type 2 asthma to meet the multicomponent end point for on-treatment clinical asthma remission for up to 2 years.
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