Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2026
Improved asthma outcomes with dupilumab plus medium-dose inhaled corticosteroids vs placebo plus high-dose inhaled corticosteroids.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Busse William W, Castro Mario, Lugogo Njira L, O'Byrne Paul M, Bacharier Leonard B, Xia Changming, Ledanois Olivier, Soliman Mena
Аннотация
BACKGROUND: Escalating from medium-dose inhaled corticosteroid (ICS) to high-dose ICS in patients with asthma offers limited clinical benefit.
OBJECTIVE: To assess the advantages of adding dupilumab to medium-dose ICS vs continuing high-dose ICS in patients with uncontrolled, moderate-to-severe asthma.
METHODS: In the phase 3 QUEST study (NCT02414854), patients receiving medium- or high-dose ICS (>250-500 or >500 µg/d fluticasone propionate or equivalent) and long-acting β2-agonists (± third controller) initiated dupilumab 200/300 mg every 2 weeks or placebo for 52 weeks. This post hoc analysis of 1584 patients with baseline eosinophils of at least 150 cells/µL or fractional exhaled nitric oxide greater than or equal to 20 parts per billion and 1 or more exacerbations in the past year assessed annualized severe exacerbation rates, changes from baseline in prebronchodilator forced expiratory volume in 1 second, type 2 inflammatory biomarkers over 52 weeks, and the proportion of patients achieving asthma control (5-item Asthma Control Questionnaire score < 1.5), grouped by treatment (dupilumab or placebo plus medium- or high-dose ICS).
RESULTS: Dupilumab improved clinical outcomes and reduced biomarker levels across ICS-dose subgroups. Dupilumab plus medium-dose ICS (n = 513) reduced exacerbations by 70% vs placebo plus high-dose ICS (n = 287) (P < .0001). At week 52, dupilumab plus medium-dose ICS improved prebronchodilator forced expiratory volume in 1 second by 0.22 L (P < .0001) and increased the odds ratio for achieving asthma control to 2.26 (P < .0001) vs placebo plus high-dose ICS.
CONCLUSION: Add-on dupilumab with medium-dose ICS improved outcomes in patients with uncontrolled asthma compared with high-dose ICS and placebo. The QUEST study was not designed to compare add-on dupilumab with ICS dose escalation, but these findings from this post hoc analysis warrant future studies directly comparing ICS dose escalation with add-on dupilumab.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02414854.
OBJECTIVE: To assess the advantages of adding dupilumab to medium-dose ICS vs continuing high-dose ICS in patients with uncontrolled, moderate-to-severe asthma.
METHODS: In the phase 3 QUEST study (NCT02414854), patients receiving medium- or high-dose ICS (>250-500 or >500 µg/d fluticasone propionate or equivalent) and long-acting β2-agonists (± third controller) initiated dupilumab 200/300 mg every 2 weeks or placebo for 52 weeks. This post hoc analysis of 1584 patients with baseline eosinophils of at least 150 cells/µL or fractional exhaled nitric oxide greater than or equal to 20 parts per billion and 1 or more exacerbations in the past year assessed annualized severe exacerbation rates, changes from baseline in prebronchodilator forced expiratory volume in 1 second, type 2 inflammatory biomarkers over 52 weeks, and the proportion of patients achieving asthma control (5-item Asthma Control Questionnaire score < 1.5), grouped by treatment (dupilumab or placebo plus medium- or high-dose ICS).
RESULTS: Dupilumab improved clinical outcomes and reduced biomarker levels across ICS-dose subgroups. Dupilumab plus medium-dose ICS (n = 513) reduced exacerbations by 70% vs placebo plus high-dose ICS (n = 287) (P < .0001). At week 52, dupilumab plus medium-dose ICS improved prebronchodilator forced expiratory volume in 1 second by 0.22 L (P < .0001) and increased the odds ratio for achieving asthma control to 2.26 (P < .0001) vs placebo plus high-dose ICS.
CONCLUSION: Add-on dupilumab with medium-dose ICS improved outcomes in patients with uncontrolled asthma compared with high-dose ICS and placebo. The QUEST study was not designed to compare add-on dupilumab with ICS dose escalation, but these findings from this post hoc analysis warrant future studies directly comparing ICS dose escalation with add-on dupilumab.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02414854.