The journal of allergy and clinical immunology. In practice · 2024
Dupilumab Efficacy in Children With Type 2 Asthma Receiving High- to Medium-Dose Inhaled Corticosteroids (VOYAGE).
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Maspero Jorge F, Antila Martti A, Deschildre Antoine, Bacharier Leonard B, Altincatal Arman, Laws Elizabeth, Mortensen Eric, Radwan Amr, Jacob-Nara Juby A, Deniz Yamo, Rowe Paul J, Lederer David J, Hardin Megan
Аннотация
BACKGROUND: In phase 3 VOYAGE (NCT02948959; Evaluation of Dupilumab in Children With Uncontrolled Asthma), dupilumab showed clinical efficacy with an acceptable safety profile in children aged 6 to 11 years with uncontrolled moderate to severe type 2 asthma (blood eosinophils ≥150 cells/μL or FeNO ≥20 ppb).
OBJECTIVE: We analyzed dupilumab's efficacy in children with type 2 asthma by high- or medium-dose inhaled corticosteroids (ICS) at baseline.
METHODS: Children were randomized to receive add-on dupilumab 100/200 mg (by body weight ≤30 kg/>30 kg) every 2 weeks or placebo for 52 weeks and stratified by high- or medium-dose ICS at baseline. End points were annualized severe exacerbation rate, changes from baseline in percent predicted FEV1, and seven-item Asthma Control Questionnaire-Interviewer Administered (ACQ-7-IA) score, proportions of ACQ-7-IA responders (improvement ≥0.5), and biomarker changes.
RESULTS: In children receiving high-dose (n = 152) or medium-dose (n = 195) ICS at baseline, dupilumab versus placebo reduced severe exacerbation rates by 63% (P < .001) and 59% (P = .003), respectively. At week 52, dupilumab improved percent predicted FEV1 by least squares mean difference versus placebo of 5.7 percentage points (P = .02) and 9.35 points (P < .001), and reduced ACQ-7-IA scores by 0.53 points (P < .001) and 0.40 points (P < .001), respectively. No significant treatment interactions between ICS subgroups were detected at week 52. Significant improvements were observed in ACQ-7-IA responder rates and most type 2 biomarker levels.
CONCLUSION: Dupilumab reduced severe exacerbation rates and improved lung function and asthma control in children with uncontrolled moderate to severe type 2 asthma regardless of ICS dose at baseline.
OBJECTIVE: We analyzed dupilumab's efficacy in children with type 2 asthma by high- or medium-dose inhaled corticosteroids (ICS) at baseline.
METHODS: Children were randomized to receive add-on dupilumab 100/200 mg (by body weight ≤30 kg/>30 kg) every 2 weeks or placebo for 52 weeks and stratified by high- or medium-dose ICS at baseline. End points were annualized severe exacerbation rate, changes from baseline in percent predicted FEV1, and seven-item Asthma Control Questionnaire-Interviewer Administered (ACQ-7-IA) score, proportions of ACQ-7-IA responders (improvement ≥0.5), and biomarker changes.
RESULTS: In children receiving high-dose (n = 152) or medium-dose (n = 195) ICS at baseline, dupilumab versus placebo reduced severe exacerbation rates by 63% (P < .001) and 59% (P = .003), respectively. At week 52, dupilumab improved percent predicted FEV1 by least squares mean difference versus placebo of 5.7 percentage points (P = .02) and 9.35 points (P < .001), and reduced ACQ-7-IA scores by 0.53 points (P < .001) and 0.40 points (P < .001), respectively. No significant treatment interactions between ICS subgroups were detected at week 52. Significant improvements were observed in ACQ-7-IA responder rates and most type 2 biomarker levels.
CONCLUSION: Dupilumab reduced severe exacerbation rates and improved lung function and asthma control in children with uncontrolled moderate to severe type 2 asthma regardless of ICS dose at baseline.