Dupilumab long-term efficacy in patients with non–OCS–dependent asthma with and without evidence of allergic asthma

医学 杜皮鲁玛 哮喘 恶化 空气过敏原 内科学 安慰剂 过敏性哮喘 过敏 免疫学 过敏原 病理 替代医学
作者
Lawrence Sher,Jonathan Corren,Ian Pavord,Nadia Daizadeh,Arman Altincatal,Xavier Soler,Michel Djandji,Amr Radwan,Juby A. Jacob‐Nara,Yamo Deniz,Paul J. Rowe
出处
期刊:Journal of Asthma [Taylor & Francis]
卷期号:60 (9): 1767-1774 被引量:4
标识
DOI:10.1080/02770903.2023.2185895
摘要

The open-label extension TRAVERSE study (NCT02134028) assessed dupilumab long-term safety and efficacy in patients who completed Phase 2/3 dupilumab asthma studies. This post hoc analysis evaluated long-term efficacy in type 2 patients with and without evidence of allergic asthma who enrolled in TRAVERSE from Phase 3 QUEST (NCT02414854) and Phase 2b (NCT01854047) studies. Non-type 2 patients with evidence of allergic asthma were also assessed.Unadjusted annualized exacerbation rates during parent study and TRAVERSE treatment period, and changes from parent study baseline in pre-bronchodilator forced expiratory volume in 1 s (FEV1) and in 5-item Asthma Control Questionnaire (ACQ-5) scores were assessed in patients from QUEST and Phase 2b; change from parent study baseline in total IgE level was assessed in patients enrolled from Phase 2b.2062 patients from Phase 2b and QUEST enrolled in TRAVERSE. Of these, 969 were type 2 with evidence of allergic asthma; 710 were type 2 without evidence of allergic asthma; and 194 were non-type 2 with evidence of allergic asthma at parent study baseline. In these populations, reductions in exacerbation rates observed during parent studies were sustained during TRAVERSE. Type 2 patients who switched from placebo arm to dupilumab in TRAVERSE experienced similar reductions in severe exacerbation rates, and improvements in lung function and asthma control to those patients who already received dupilumab during the parent study.Dupilumab efficacy was sustained for up to 3 years in patients with uncontrolled, moderate-to-severe type 2 inflammatory asthma, with or without evidence of allergic asthma.ClinicalTrials.gov identifier: NCT02134028.

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