P4.A008: Improved Lung Function is Associated With Better Asthma Control in Children With Moderate-to-Severe Type 2 Asthma: VOYAGE Study

Background: There is a need to better examine the relationship between lung function improvement and patient-reported outcomes. In the LIBERTY ASTHMA VOYAGE study (NCT02948959), dupilumab significantly reduced asthma exacerbations and improved lung function, asthma 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 the association between lung function change and asthma control in children with type 2 asthma (baseline blood eosinophil count ≥150 cells/µL or fractional exhaled nitric oxide [FeNO] ≥20 parts per billion).

Methods: A total of 321 children received add-on dupilumab 100/200 mg every 2 weeks (body-weight based) or placebo for 52 weeks. We stratified patients into 3 subgroups: low, medium, or high tertiles according to change from baseline in pre-bronchodilator percent predicted forced expiratory volume in 1 second (ppFEV1) to Week 52. Using logistic regression models with tertiles in each treatment group, age, weight, region, baseline eosinophils, FeNO, inhaled corticosteroid dose, baseline pre-bronchodilator (BD) ppFEV1, and baseline Interviewer-Administered 5-item Asthma Control Questionnaire score (ACQ-5-IA) as covariates, we assessed the proportion and odds ratio (OR) of children achieving well-controlled asthma (ACQ-5-IA ≤0.75) at Week 52 between tertile subgroups within each treatment arm.

Results: In children who received dupilumab, mean (SD) change from baseline in pre-BD ppFEV1 at Week 52 was −5.91 (8.61), 8.05 (3.28), and 28.17 (17.45) percentage points in low- (n=56), medium- (n=73), and high- (n=86) tertile subgroups, respectively, and −8.04 (9.25), 6.44 (2.95), and 22.29 (8.09) percentage points in low- (n=46), medium- (n=36), and high- (n=24) tertile subgroups, respectively, in the placebo arm. Compared with the dupilumab low-tertile subgroup, significantly greater proportions of children achieved well-controlled asthma in the dupilumab medium- (86.3%; OR [95% CI]=4.38 [1.57–12.18]; P=0.0046) and high- (82.6%; OR [95% CI]=3.79 [1.34–10.75]; P=0.0123) tertile subgroups (Figure A). In the placebo arm, the proportion of well-controlled asthma patients was significantly higher in the high- vs low-tertile subgroup only (62.5% vs 54.3%; OR [95% CI]=3.90 [1.14–13.34]; P=0.030) (Figure B).

Conclusion: In children with moderate-to-severe type 2 asthma, improvements in lung function were associated with better asthma control within the dupilumab and placebo treatment arms.