LONG-TERM DUPILUMAB ASSESSMENT IN CHILDREN WITH TYPE 2 ASTHMA WITH OR WITHOUT EVIDENCE ALLERGIC ASTHMA

Abstract

Introduction

Dupilumab, a human monoclonal antibody blocking interleukins 4/13 signaling, demonstrated efficacy in children (6–11 years) with moderate-to-severe type 2 asthma (blood eosinophils ≥150cells/µL or fractional exhaled nitric oxide ≥20ppb) in VOYAGE (NCT02948959) and in the single-arm, open-label EXCURSION (NCT035604666) extension study. We assessed dupilumab efficacy in children in EXCURSION, with/without evidence of allergic asthma (total serum IgE ≥30IU/mL and ≥1 perennial aeroallergen-specific IgE ≥0.35kU/L at baseline).

Methods

In VOYAGE, children received add-on dupilumab 100/200mg q2w (by bodyweight) or placebo for 52 weeks; in EXCURSION, all received dupilumab for 52 weeks. Endpoints: annualized severe exacerbation rates; change from VOYAGE baseline in pre-bronchodilator percent predicted forced expiratory volume in 1 second (ppFEV₁) by presence/absence of allergic asthma. Only descriptive analyses are available for EXCURSION outcomes.

Results

In VOYAGE, dupilumab reduced exacerbations by 57.0% in patients with evidence of allergic asthma and by 49.1% in those without. Reductions were sustained in EXCURSION. At Week 52 (VOYAGE): dupilumab significantly improved pre-bronchodilator ppFEV₁ in children with allergic asthma (least squares [LS] mean difference vs placebo [95% CI]: 9.45 [5.14 to 13.77]; P<0.0001), with a numerical improvement in those without (4.60 [−1.99 to 11.20]; P=0.1685). In EXCURSION (Week 52), pre-bronchodilator ppFEV₁ improvements were sustained regardless of allergic status: mean (SD) change 13.1% (19.5)/9.9% (15.9) for dupilumab-dupilumab/placebo-dupilumab groups with allergic asthma, and 11.2% (13.5)/8.4% (17.3) in children without allergic asthma.

Conclusions

Dupilumab reduced severe exacerbations and improved lung function up to 2 years in children with moderate-to-severe type 2 asthma, irrespective of allergic status.