{Reference Type}: Randomized Controlled Trial
{Title}: Dupilumab Improves Lung Function Parameters in Pediatric Type 2 Asthma: VOYAGE Study.
{Author}: Bacharier LB;Guilbert TW;Katelaris CH;Deschildre A;Phipatanakul W;Liu D;Altincatal A;Mannent LP;Amin N;Laws E;Akinlade B;Jacob-Nara JA;Deniz Y;Rowe PJ;Lederer DJ;Hardin M;
{Journal}: J Allergy Clin Immunol Pract
{Volume}: 12
{Issue}: 4
{Year}: 2024 Apr 11
暂无{DOI}: 10.1016/j.jaip.2023.12.006
{Abstract}: <B>BACKGROUND: </B>Uncontrolled asthma in growing children can impair lung growth that may lead to adverse complications in later life. Dupilumab, a human monoclonal antibody, blocks the shared receptor for IL-4 and IL-13, key drivers of type 2 inflammation.<BR><B>OBJECTIVE: </B>To extensively evaluate the effect of dupilumab on lung function in children (6-11 years) with moderate-to-severe asthma enrolled in phase 3 LIBERTY ASTHMA VOYAGE (NCT02948959).<BR><B>METHODS: </B>Children with asthma were randomized 2:1 to add-on dupilumab 100/200 mg by bodyweight or placebo every 2 weeks, for 52 weeks. We analyzed spirometry parameters in children with type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥20 parts per billion [ppb] at baseline) and within subgroups defined by baseline blood eosinophils or FeNO values.<BR><B>RESULTS: </B>A total of 116 (49%) dupilumab-treated children and 59 (52%) on placebo had impaired lung function (prebronchodilator percent-predicted forced expiratory volume in 1 second [ppFEV1] <80%) at baseline. Dupilumab improved pre- and postbronchodilator ppFEV1 as early as week 2, sustained for up to 52 weeks (least-squares mean difference vs placebo at week 52: 7.79 percentage points; 95% confidence interval [CI]: 4.36-11.22; P < .001 and 4.37 points; 95% CI: 0.95-7.78; P = .01, respectively). Sustained improvements were also observed in other lung function parameters, including pre- and postbronchodilator forced vital capacity (FVC), prebronchodilator forced expiratory flow, and FEV1/FVC ratio across all populations.<BR><B>CONCLUSIONS: </B>Dupilumab led to significant, sustained lung function improvements across a range of lung function measures in children (6-11 years) with uncontrolled, moderate-to-severe type 2 asthma.