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
{"title":"杜匹单抗可诱导 2 型哮喘患者长期临床缓解。","authors":"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","doi":"10.1016/j.jaip.2024.10.009","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Remission is proposed as a multicomponent outcome for patients with severe asthma.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":51323,"journal":{"name":"Journal of Allergy and Clinical Immunology-In Practice","volume":" ","pages":""},"PeriodicalIF":8.2000,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Dupilumab Induces Long-term On-Treatment Clinical Remission in Patients With Type 2 Asthma.\",\"authors\":\"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\",\"doi\":\"10.1016/j.jaip.2024.10.009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Remission is proposed as a multicomponent outcome for patients with severe asthma.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":51323,\"journal\":{\"name\":\"Journal of Allergy and Clinical Immunology-In Practice\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":8.2000,\"publicationDate\":\"2024-10-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Allergy and Clinical Immunology-In Practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jaip.2024.10.009\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Allergy and Clinical Immunology-In Practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jaip.2024.10.009","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
Dupilumab Induces Long-term On-Treatment Clinical Remission in Patients With Type 2 Asthma.
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.
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.