Dupilumab Induces Long-term On-Treatment Clinical Remission in Patients With Type 2 Asthma.

IF 8.2 1区医学 Q1 ALLERGY

Journal of Allergy and Clinical Immunology-In Practice Pub Date : 2024-10-16 DOI:10.1016/j.jaip.2024.10.009

Ian D Pavord, Klaus F Rabe, Elliot Israel, Stanley J Szefler, Guy Brusselle, Nami Pandit-Abid, Arman Altincatal, Zhen Chen, Nikhil Amin, Asif H Khan, David J Lederer, Yi Zhang, Paul J Rowe, Yamo Deniz, Amr Radwan, Juby A Jacob-Nara, William W Busse

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引用次数: 0

Abstract

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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杜匹单抗可诱导 2 型哮喘患者长期临床缓解。

背景：缓解被认为是重症哮喘患者的一个多因素结果：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、零口服皮质类固醇[OCS]用量、肺功能稳定或改善、患者报告的哮喘控制）：在QUEST中，患者（≥12岁）被随机分配到每两周一次（q2w）的dupilumab 200/300毫克或安慰剂中，共52周。在TRAVERSE研究中，所有患者均接受300毫克的dupilumab治疗，每两周一次，最长96周。我们评估了在 TRAVERSE 48 周内达到治疗中临床缓解标准的患者比例：在QUEST基线，1040名接受杜比鲁单抗治疗的患者和544名服用安慰剂的患者患有2型哮喘；其中842名（杜比鲁单抗/杜比鲁单抗）和437名（安慰剂/杜比鲁单抗）参加了TRAVERSE。在QUEST第52周（第1年），37.2%接受dupilumab治疗的患者达到了临床缓解标准，而接受安慰剂治疗的患者只有22.2%达到了临床缓解标准（所有P均小于0.001）。在TRAVERSE第48周（第二年），42.8%（dupilumab/dupilumab）和33.4%（安慰剂/dupilumab）的患者达到了临床缓解标准。总体而言，29.5%的杜匹单抗/杜匹单抗组患者在第一年和第二年都达到了标准：结论：杜匹单抗治疗可使约三分之一的2型哮喘患者在长达2年的治疗中达到哮喘临床缓解的多组分终点。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Allergy and Clinical Immunology-In Practice ALLERGYIMMUNOLOGY-IMMUNOLOGY

CiteScore

11.10

自引率

9.60%

发文量

683

审稿时长

50 days

期刊介绍： JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases. This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders. The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.