Abstract

<b>Background:</b> Asthma is the most common chronic respiratory condition in children, who may have uncontrolled disease despite maximal therapy. Type 2 (T2) inflammation (blood eosinophils ≥150 cells/µL or FeNO ≥20 ppb) underlies most pediatric asthma. Dupilumab (DPL), a fully human mAb, blocks the shared receptor component for IL-4/13, key and central drivers of T2 inflammation. VOYAGE, a 52-week randomized, double-blind, placebo (PBO)-controlled phase 3 study (NCT02948959), evaluated DPL efficacy/safety in children aged 6–11 years with uncontrolled persistent asthma. <b>Aim:</b> Assess DPL impact on asthma control (ACQ-7-IA) and health-related quality of life (HRQoL; PAQLQ[S]-IA) in VOYAGE T2 patients (pts). <b>Methods:</b> Change from baseline in ACQ-7-IA/PAQLQ[S]-IA scores, percentage of responders (improvement ≥0.5) or pts who achieved well-controlled asthma (ACQ-7-IA score ≤0.75). <b>Results:</b> DPL vs PBO rapidly improved asthma control by Week (Wk)4 and was sustained to Wk52 (<i>P</i>&lt;0.05). At Wk24, 79% DPL vs 69% PBO pts were ACQ-7-IA responders and 61% DPL vs 43% PBO achieved well-controlled asthma (<i>P</i>&lt;0.05). From Wk36, DPL vs PBO significantly improved PAQLQ[S]-IA scores across all domains—symptoms, activity limitation, emotional. A higher proportion of DPL vs PBO pts were PAQLQ[S]-IA responders at Wk52 (<i>P</i>&lt;0.05; <b>Figure</b>). <b>Conclusion:</b> In children with uncontrolled T2 asthma, DPL rapidly improved asthma control. HRQoL also improved over time.

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