Impact of dupilumab across seasons in patients with type 2, uncontrolled, moderate-to-severe asthma
- PMID: 38013139
- DOI: 10.1016/j.anai.2023.11.021
Impact of dupilumab across seasons in patients with type 2, uncontrolled, moderate-to-severe asthma
Abstract
Background: Seasonal variability could influence asthma exacerbations. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4/IL-13, key and central drivers of type 2 inflammation. In the 52-week QUEST study (NCT02414854), add-on dupilumab every 2 weeks vs placebo significantly reduced exacerbations and improved prebronchodilator forced expiratory volume in 1 second in patients with uncontrolled, moderate-to-severe asthma. TRAVERSE (NCT02134028), the open-label QUEST extension study, enrolled patients with moderate-to-severe asthma to investigate long-term safety and efficacy of dupilumab, including patients who previously received placebo that initiated dupilumab therapy.
Objective: To investigate long-term dupilumab efficacy in reducing exacerbations across yearly seasons in patients with type 2 inflammatory asthma with and without clinical evidence of allergic asthma.
Methods: Unadjusted annualized exacerbation rate and proportions of patients experiencing severe asthma exacerbations are reported by month and season and for both hemispheres.
Results: The proportion of patients with type 2 asthma experiencing 1 or more severe asthma exacerbations during QUEST was 20.8% vs 10.0% in spring, 18.2% vs 7.3% in summer, 22.2% vs 12.6% in autumn, and 26.4% vs 12.0% in winter, for placebo- vs dupilumab-treated patients, respectively; P was less than .001 for placebo vs dupilumab in all seasons. Reductions in the proportion of patients experiencing severe exacerbations across seasons in subgroups with and without evidence of allergic asthma were similar to the overall type 2 population. Reductions in severe exacerbations observed during QUEST were sustained during TRAVERSE, up to 96 weeks across both hemispheres.
Conclusion: Dupilumab reduced asthma exacerbations, with no difference in the reduction between seasons, in patients with type 2 inflammation, with and without evidence of allergic asthma.
Trial registration: ClinicalTrials.gov Identifiers: NCT02414854, NCT02134028.
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Disclosures Dr Peters has served as a consultant for and received research support from Regeneron Pharmaceuticals Inc. and Sanofi, received research support from AstraZeneca, and provided consultancy for Optinose. Dr Sagara has received speaker fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Sanofi. Dr Corren reports receiving research grants from and providing consultancy for AstraZeneca, Genentech, Novartis, Regeneron Pharmaceuticals Inc., and Sanofi and has received speaker fees from AstraZeneca, Genentech, and Novartis. Dr Domingo reports receiving travel and speaker fees from ALK, Allergy Therapeutics, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, HAL Allergy, ImmunoTek, Menarini, Novartis, Pfizer, Sanofi-Aventis, Stallergenes Greer, and Teva. Mr Altincatal, Dr Pandit-Abid, Dr Rowe, and Dr Jacob-Nara are Sanofi employees and may hold stock and/or stock options in the company. Dr Soler, Ms Crikelair, and Dr Deniz are employees and shareholders of Regeneron Pharmaceuticals Inc.
Comment in
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'Tis the season for dupilumab?Ann Allergy Asthma Immunol. 2024 Apr;132(4):413-414. doi: 10.1016/j.anai.2024.01.020. Ann Allergy Asthma Immunol. 2024. PMID: 38569752 No abstract available.