P4.A004: Dupilumab Reduces Corticosteroid Use in Children With Uncontrolled Moderate-to-Severe Asthma Regardless of Exacerbation History

Background: There is a need to limit systemic corticosteroid (SCS) exposure in children with asthma. In VOYAGE (NCT02948959), dupilumab significantly reduced severe asthma exacerbations, improved lung function and was well tolerated in children (6 to 11 years) with moderate-to-severe asthma. This post-hoc analysis assessed dupilumab efficacy in reducing rescue SCS use in children with moderate-to-severe type 2 asthma (baseline blood eosinophil count ≥150 cells/µL or fractional exhaled nitric oxide ≥20 parts per billion).

Methods: Children received dupilumab 100/200 mg or placebo, every 2 weeks for 52 weeks. Unadjusted annualized severe exacerbation rate, number of total SCS courses, and change from baseline in pre-bronchodilator percent predicted forced expiratory volume in 1 second (ppFEV1) were analysed in patients stratified by number of exacerbations (1, 2, or ≥3) in the year prior to VOYAGE.

Results: Dupilumab vs placebo reduced severe exacerbation rates for children with type 2 asthma, with 1 (0.143 [n=77] vs 0.463 [n=43]), 2 (0.290 [n=69] vs 0.678 [n=31]), or ≥3 (0.682 [n=63] vs 0.994 [n=32]) prior exacerbations. Unadjusted annualized number of SCS courses were 0.16 vs 0.49/0.33 vs 0.74/0.78 vs 1.18, respectively. Dupilumab vs placebo improved ppFEV1 by Week 2 (Mean [SD] change from baseline: 6.2 (13.9) vs 1.9 (10.5)%/10.7 (16.4) vs 8.4 (12.8)%/8.2 (13.6) vs 2.6 (15.6)%; Week 52: 10.6 (15.9) vs 3.0 (12.1)%/ 17.3 (23.6) vs 5.8 (12.7)%/10.0 (14.7) vs 3.0 (18.0)%) with 1, 2, and ≥3 prior exacerbations, respectively.

Conclusion: In children with uncontrolled moderate-to-severe type 2 asthma, dupilumab reduced corticosteroid burden related to exacerbations, regardless of exacerbation history.