PUB - Publikationen an der Universität Bielefeld

Introduction: Persistent lung function impairment in children with asthma is associated with impaired quality of life and risk of exacerbation. In phase 3 LIBERTY ASTHMA VOYAGE (NCT02948959), add-on dupilumab (DPL) was generally well tolerated and significantly reduced the annualized rate of severe exacerbations (AER) and improved lung function in children. Aims and objectives: To evaluate lung function responder rates at Week (Wk)12 and Wk52 of VOYAGE. Methods: Children 6–11 years with uncontrolled, moderate-to-severe, type 2 asthma (baseline [BL] blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide ≥20 ppb) were randomized to dupilumab 100mg/200mg (based on bodyweight) q2w or volume-matched placebo for 52 wks. Endpoints: least squares mean (LSM) change from BL in % predicted pre-BD FEV1 (ppFEV1) at Wk12 and 52; proportion of patients with ≥10% improvement in ppFEV1 at Wk12 and 52; and AER in those responders. Results: ppFEV1 was significantly improved with DPL vs placebo (PBO) at Wk12 (LSM difference [95% CI] 5.20 [2.14–8.26]; P= 0.0009) and Wk52 (7.79 [4.36–11.22]; P<0.0001). A ≥10% ppFEV1 improvement was achieved at Wk12 in 44.9% (n=106; [38.5–51.5]) vs 31.6% (n=36; [23.2–40.9]; P=0.0173) and at Wk52 in 47.5% (n=112; [40.9–54.0]) vs 28.1% (n=32; [20.1–37.3]; P=0.0006) of patients receiving DPL vs PBO, respectively. DPL vs PBO significantly decreased the AER in patients achieving ≥10% ppFEV1 improvement, 0.304 (n=106; [0.185–0.500]) vs 0.744 (n=36; [0.424–1.308]; P=0.0103), respectively.