Late Breaking Abstract - Clinical remission with dupilumab in children with uncontrolled, moderate-to-severe, type 2 asthma

<bold>INTRODUCTION:</bold> Dupilumab, a human monoclonal antibody, blocks signaling of interleukins 4/13, central drivers of type 2 inflammation. In phase 3 VOYAGE (<ext-link>NCT02948959</ext-link>), dupilumab reduced severe exacerbations and improved lung function and asthma control vs placebo in children (6 to 11 years) with moderate-to-severe type 2 asthma (baseline blood eosinophil count ≥150 cells/µL or fractional exhaled nitric oxide ≥20 ppb). Here, we assessed the effect of dupilumab in achieving on-treatment clinical remission, a proposed composite endpoint, in children in VOYAGE. <bold>METHODS:</bold> We assessed proportions of children achieving on-treatment clinical remission (no exacerbations/oral corticosteroid use; <italic>z</italic>-score >−1.64 for both pre-bronchodilator forced expiratory volume in 1 second (FEV₁)/forced vital capacity ratio and pre-bronchodilator FEV₁; and 5-item Asthma Control Questionnaire (ACQ-5) score <0.75.) <bold>RESULTS:</bold> 236 children received add-on dupilumab and 114 placebo. At baseline, no children in either treatment group met the requirements for remission using ACQ-5 <0.75. A significantly higher proportion of children receiving dupilumab vs placebo achieved clinical remission at Week 52 (41.9% vs 23.7%; <italic>P</italic>=0.0008; <bold>Figure</bold>). <bold>CONCLUSION:</bold> Compared with placebo, dupilumab significantly increased the proportion of patients with uncontrolled, moderate-to-severe type 2 asthma who achieved on-treatment clinical asthma remission at Week 52. <fig><object-id>erj;64/suppl_68/RCT3719/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>