Aim To assess the impact of dupilumab on severe exacerbations, systemic corticosteroid (SCS) use, and lung function in children with moderate-to-severe asthma.

Material and Method In VOYAGE (NCT02948959), children aged 6–11 years with uncontrolled moderate-to-severe type 2 inflammatory asthma were randomized 1:2 to placebo or dupilumab for 52 weeks. Children could then receive dupilumab for 52 weeks in EXCURSION (NCT03560466). We report annualized severe exacerbation event rates, annualized SCS courses, and changes from baseline in percentage of predicted pre-bronchodilator forced expiratory volume in 1 second (ppFEV1) among children who completed VOYAGE and entered EXCURSION, stratified by exacerbation history (1 or ≥2) in the year before VOYAGE.

Results 43 placebo and 77 dupilumab recipients had 1 exacerbation in the year before VOYAGE, while 63 placebo and 132 dupilumab recipients had ≥2. During VOYAGE, annualized severe exacerbation event rates with placebo and dupilumab were 0.46 vs 0.14 and 0.84 vs 0.48 among those with 1 or ≥2 prior exacerbations/year, respectively. During EXCURSION, they were 0.09 vs 0.09 and 0.20 vs 0.18, respectively, for placebo/dupilumab vs dupilumab/dupilumab. SCS use was higher with placebo vs dupilumab in VOYAGE (annualized courses 0.49 vs 0.16 and 0.97 vs 0.55 among those with 1 or ≥2 prior exacerbations/year, respectively), but similar for placebo/dupilumab vs dupilumab/dupilumab during EXCURSION (0.12 vs 0.09 and 0.27 vs 0.23, respectively). Mean (SD) changes from baseline in ppFEV1 (%) at Week 52 in VOYAGE were 3.0 (12.1) vs 10.6 (15.9) and 4.4 (15.4) vs 13.8 (20.1) among those with 1 or ≥2 prior exacerbations/year, respectively; at Week 52 in EXCURSION they were 2.5 (14.3) vs 7.4 (10.0) and 14.4 (18.7) vs 9.6 (14.9), respectively.

Conclusions Among children with uncontrolled moderate-to-severe type 2 asthma, dupilumab reduced severe exacerbations and SCS exposure while improving/maintaining lung function for up to 2 years, regardless of exacerbation history.