OBJECTIVES: There is a need to decrease systemic corticosteroid (SCS) exposure for the treatment of exacerbations in children with asthma. Dupilumab is an antibody that blocks the shared receptor component of interleukin (IL)‑4 and IL-13, key and central drivers of type 2 inflammation. In the Phase 3 study VOYAGE (NCT02948959), dupilumab was well tolerated, significantly reduced severe asthma exacerbations, and improved lung function, in children with uncontrolled moderate-to-severe asthma. This post-hoc analysis assessed dupilumab efficacy in reducing the need for rescue SCS in children with type 2 inflammation (baseline blood eosinophils ≥150cells/µL or FeNO ≥20ppb).

METHODS: Children aged 6–11 years were randomized to dupilumab 100/200mg or placebo, every 2 weeks for 52 weeks. The annualized number of total SCS courses, cumulative oral corticosteroid (OCS) dose and change from baseline in percent predicted (pp)FEV₁ were analysed in subgroups of patients stratified by number of exacerbations prior to VOYAGE.

RESULTS: Unadjusted annualized total SCS courses in children with type 2 asthma, with 1, 2 and ≥3 prior exacerbations in placebo vs dupilumab treatment arms were 0.49 vs 0.16, 0.74 vs 0.33, and 1.18 vs 0.78. Mean (SD) cumulative OCS dose in placebo vs dupilumab was 182.63mg (108.29) vs 119.55mg (81.99), 222.62mg (198.05) vs 196.52mg (202.46), and 420.80mg (332.96) vs 304.54mg (342.51), in patients with 1, 2 and ≥3 prior exacerbations. Mean (SD) change from baseline in ppFEV1 (%) at week2 in placebo vs dupilumab arms were 1.9 (10.5) vs 6.2 (13.89), 8.4 (12.75) vs 10.7 (16.4), and 2.6 (15.6) vs 8.2 (13.6), and at week12, 2.7 (10.6) vs 11.4 (15.4), 7.7 (12.8) vs 12.5 (18.5), and 3.3 (16.4) vs 9.7 (13.6) in patients with 1, 2 and ≥3 prior exacerbations.

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