Aim The relationship between lung function improvement and patient-reported outcomes is unclear. In LIBERTY ASTHMA VOYAGE (NCT02948959), dupilumab reduced exacerbations and improved lung function, control, and quality of life in children (aged 6 to 11 years) with uncontrolled, moderate-to-severe asthma, with an acceptable safety profile. This post hoc analysis evaluated association between lung function change and asthma control in children with type 2 asthma (baseline blood eosinophils ≥150 cells/µL or fractional exhaled nitric oxide [FeNO] ≥20 ppb) in each treatment group.

Material and Method 321 children were randomized 2:1 to receive add-on dupilumab 100/200 mg q2w (body-weight based) or placebo for 52 weeks. We stratified patients into low, medium, or high tertiles according to change in pre-bronchodilator percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline to Week 52. We assessed proportion and odds ratio (OR) of children achieving controlled and well-controlled asthma (Interviewer-Administered 5-item Asthma Control Questionnaire score [ACQ-5-IA]: <1.5 and ≤0.75, respectively) at Week 52 between tertile subgroups within each treatment arm using logistic regression models with age, weight, region, baseline eosinophils, FeNO, inhaled corticosteroid dose, baseline pre-bronchodilator ppFEV1, baseline ACQ-5-IA, and per-treatment tertile subgroups as covariates.

Results Dupilumab and placebo arms showed a mean reduction from baseline in pre-bronchodilator ppFEV1 at Week 52 in the low tertile and mean improvement in both medium- and high-tertile subgroups (table 1). Significantly greater proportions of children achieved well-controlled asthma in the dupilumab medium- and high-tertile vs low-tertile subgroup (table 1). In the placebo arm, the proportion of well-controlled asthma patients was significantly higher in the high- vs low-tertile subgroup only (table 1). Tertile subgroups were not significantly different in achievement of controlled asthma for dupilumab vs. placebo.

Conclusions In children with moderate-to-severe type 2 asthma, improvements in lung function were associated with achieving well-controlled asthma within dupilumab and placebo treatment arms.