Baseline Predictors of Clinical Remission in Children With Uncontrolled, Moderate-to-Severe Asthma Treated with Dupilumab: A Post Hoc Analysis of The VOYAGE Study

Rationale: Clinical remission is an emerging treatment goal in childhood asthma. This post hoc analysis evaluated the predictive value of baseline characteristics for achieving clinical remission in children (6 to 11 years) with uncontrolled moderate-to-severe asthma from the Phase 3 VOYAGE study (NCT02948959). Methods: In VOYAGE, children received either add-on dupilumab 100/200 mg (by body weight) or placebo every two weeks for 52 weeks. A multivariate logistic regression model was used to evaluate proportion of patients achieving clinical remission (defined as meeting 4 criteria at Week 52: no exacerbations, no oral corticosteroid use during study, 5-item Asthma Control Questionnaire score− 1.64) stratified by baseline characteristics. Results: At Week 52, 43.2% (118/273) of dupilumab and 27.4% (37/135) of placebo recipients achieved clinical remission. Dupilumab vs placebo significantly increased the likelihood of remission in children with baseline blood eosinophils≥150 cells/μL (odds ratio [95% CI] 2.56 [1.53, 4.31], P =0.0004) or baseline fractional exhaled nitric oxide (FeNO)≥20 ppb (3.18 [1.58, 6.41], P =0.0012). Dupilumab vs placebo increased remission likelihood regardless of baseline pre-bronchodilator percent predicted FEV₁ (