Dupilumab efficacy by disease severity in pediatric type 2 asthma.

BACKGROUND

Dupilumab demonstrated efficacy in children with asthma in phase 3 VOYAGE (NCT02948959) and open-label extension EXCURSION (NCT03560466) studies. This post hoc analysis assessed dupilumab's long-term efficacy by asthma severity at parent study baseline.

METHODS

Children (6-11 years) with moderate-to-severe type 2 inflammatory asthma (PS baseline blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide ≥20 ppb) from placebo-controlled VOYAGE who enrolled in EXCURSION received dupilumab every 2 weeks for an additional 52 weeks. We assessed annualized severe exacerbation rates, change in pre-bronchodilator percent predicted forced expiratory volume in 1 second (FEV1) and FEV1 z-score, and Interviewer-Administered 7-item Asthma Control Questionnaire (ACQ-7-IA) score in subgroups with moderate (medium-dose inhaled corticosteroid (ICS), pre-bronchodilator percent predicted FEV1 ≥ 80%) and severe (high-dose ICS, pre-bronchodilator percent predicted FEV1 < 80%) asthma at parent study baseline.

RESULTS

Among 179 children (104 with moderate, 75 with severe asthma), dupilumab compared to placebo reduced unadjusted annualized severe exacerbation rates during VOYAGE in children with moderate (0.22 vs. 0.37) and severe (0.41 vs. 1.07) asthma, with sustained reductions in EXCURSION (moderate: 0.07 and 0.07; severe: 0.24 and 0.19). At VOYAGE Week 52, the change from the parent study baseline in pre-bronchodilator percent predicted FEV1 was 8.6 versus 2.1 percentage points with dupilumab and placebo in children with moderate asthma, and 16.7 versus 9.8 percentage points in children with severe asthma. Improvements in the change from the parent study baseline in pre-bronchodilator FEV1 z-scores and ACQ-7-IA scores were also observed with dupilumab treatment in both subgroups.

CONCLUSION

Long-term dupilumab treatment reduced exacerbation rates and improved lung function and asthma control in children with type 2 asthma irrespective of disease severity, with numerically greater improvements in children with severe asthma.