Dupilumab efficacy in children with uncontrolled, moderate-to-severe asthma with and without an allergic phenotype

Abstract

<b>Background:</b> Most pediatric asthma patients have type 2 asthma. Dupilumab (DPL), a fully human mAb, blocks the shared receptor component for IL-4/13, key and central drivers of type 2 inflammation. In VOYAGE (NCT02948959), dupilumab 100/200mg q2w vs placebo (PBO) reduced severe asthma exacerbations and improved % predicted pre-BD FEV₁ in children aged 6–11 years with uncontrolled, moderate-to-severe type 2 asthma (baseline blood eosinophils ≥150cells/µl or FeNO ≥20ppb), and was generally well tolerated. <b>Aim:</b> To evaluate DPL efficacy in children with type 2 asthma with/without an allergic asthma phenotype. <b>Methods:</b> Annualized severe exacerbation rate (AER) was assessed using a negative binomial model. Changes from baseline (BL) in % predicted pre-BD FEV₁ and 7-item Asthma Control Questionnaire (ACQ-7) score were assessed using mixed-effect models with repeated measures (MMRM). <b>Results:</b> 75% of the type 2 patients had evidence of allergic phenotype. DPL vs PBO significantly reduced AER in patients with/without allergic phenotype. Change from BL in % predicted pre-BD FEV₁ at Week 12 and ACQ-7 at Week&nbsp;24 was greater in patients treated with DPL vs PBO in both subgroups (<b>Figure</b>). <b>Conclusion:</b> Dupilumab showed efficacy in reducing asthma exacerbations significantly in children with type 2 asthma with/without evidence of allergic asthma. Efficacy on lung function was similar in both subgroups.