PUB - Publikationen an der Universität Bielefeld

Rationale:Persistent lung function impairment in children withuncontrolled, moderate‐to‐severe asthma is associated withimpaired quality of life and long‐term risk of exacerbation andrespiratory morbidity. In the phase 3 LIBERTY ASTHMA VOYAGEstudy (NCT02948959), add‐on dupilumab, a fully human monoclo-nal antibody that blocks the shared receptor component forinterleukin (IL)‐4andIL‐13, key and central drivers of type 2inflammation, significantly reduced the annualized rate of severeexacerbations and improved lung function in children with uncon-trolled, moderate‐to‐severe, type 2 asthma (baseline blood eosino-phils≥150 cells/μL or fractional exhaled nitric oxide [FeNO]≥20parts per billion [ppb]). This analysis evaluated lung functionresponder rates at Week 12 of VOYAGE.Methods:Children between the ages of 6 and 11 years withuncontrolled, moderate‐to‐severe, type 2 asthma were randomlyassigned to receive dupilumab 100 mg or 200 mg (depending onbodyweight tier) every 2 weeks or volume‐matched placebo for 52weeks. Endpoints included the least squares mean (LSM) change frombaseline in percentage of predicted pre‐bronchodilator forcedexpiratory volume in 1 second (pre‐BD ppFEV1) at Week 12, theproportion of patients achieving≥5% and≥10% improvement inpre‐BD ppFEV1 in response to 12 weeks of dupilumab treatment,and the adjusted annualized severe exacerbation rate (AER) in thoseresponders. Results:At Week 12, pre‐BD ppFEV1 was significantly improvedwith dupilumab vs. placebo in the type 2 asthma population (LSMdifference [95% CI] 5.21 percentage points [2.14–8.27]; P = 0.0009).The proportion of patients achieving≥5% ppFEV1 improvementwith dupilumab was 59.7% (n = 141; [95% CI 53.2–66.1]) comparedwith 50.0% with placebo (n = 57; [40.5–59.5]). A≥10% ppFEV1improvement was achieved in 44.9% (n = 106; [38.5–51.5]) ofpatients receiving dupilumab vs. 31.6% (n = 36; [23.2–40.9]) ofpatients receiving placebo. Dupilumab significantly decreased theAER in patients achieving≥5% ppFEV1 improvement, 0.251 (n =141; [0.155–0.407]) vs. 0.626 (n = 57; [0.382–1.026]; p = 0.0029),and≥10% ppFEV1 improvement, 0.304 (n = 106; [0.185–0.500]) vs.0.744 (n = 36; [0.424–1.308]; p = 0.0103), compared to placebo.Conclusions:At Week 12, dupilumab significantly improved ppFEV1and more patients treated with dupilumab met the ppFEV1 respondercriteria than those treated with placebo. These patients also experienceda significantly lower AER than those treated with placebo.