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

Publication Number: 2305.316

Andrew Moraco, Sanofi, Cambridge, MA; Leonard Bacharier, Vanderbilt University Medical Center, Nashville, SD, United States; Nikolaos G. Papadopoulos, NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS GREECE, Athens, Attiki, Greece; Daniel J. Jackson, University of Wisconsin School of Medicine and Public Health, Oregon, WI, United States; Antoine Deschildre, CHU Lille, Lille, Nord-Pas-de-Calais, France; Theresa W. Guilbert, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States; Olivier Ledanois, Sanofi, Paris, Ile-de-France, France; Rebecca Gall, Regeneron Pharmaceuticals, Sleepy Hollow, NY, United States

Background: Clinical remission is an emerging treatment goal in childhood asthma.

Objective: 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).

Design/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 < 1.5, and pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity and pre-bronchodilator FEV1 z-scores >−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 ( < 80%: 2.09 [1.00, 4.34], P=0.0493; ≥80%: 2.16 [1.17, 3.97], P=0.0137), or pre-bronchodilator FEV₁ z-score (<−1.645: 2.19 [1.03, 4.66], P=0.0418; ≥−1.645: 2.06 [1.13, 3.77], P=0.0183).

Conclusion(s): In children with moderate-to-severe asthma, baseline blood eosinophils counts ≥150 cells/µL or FeNO levels ≥20 ppb were associated with a higher likelihood of achieving clinical remission following dupilumab treatment.