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Dupilumab efficacy by disease severity in pediatric type 2 asthma
Daniel J Jackson1, Monika Gappa2, Leonard B Bacharier3
1University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
Insights
Long-term dupilumab treatment effectively reduced asthma exacerbations and improved lung function in children with moderate-to-severe type 2 asthma. These benefits were observed regardless of initial disease severity, indicating broad efficacy for this asthma biologic.
Area of Science:
- Pediatric Pulmonology
- Immunology
- Clinical Pharmacology
Background:
- Dupilumab has shown efficacy in pediatric asthma patients.
- This study is a post hoc analysis of the VOYAGE and EXCURSION trials.
- The analysis focuses on long-term dupilumab efficacy based on asthma severity at baseline.
Purpose of the Study:
- To assess the long-term efficacy of dupilumab in children with moderate-to-severe type 2 asthma.
- To evaluate efficacy based on asthma severity (moderate vs. severe) at the start of the parent study.
Main Methods:
- Children aged 6-11 years with moderate-to-severe type 2 asthma were included.
- Participants received dupilumab every 2 weeks for an additional 52 weeks.
- Outcomes measured included severe exacerbation rates, lung function (FEV1, FEV1 z-score), and asthma control (ACQ-7-IA).
Main Results:
- Dupilumab significantly reduced annualized severe exacerbation rates in both moderate and severe asthma subgroups compared to placebo.
- Sustained reductions in exacerbations were observed during the extension study.
- Improvements in pre-bronchodilator percent predicted FEV1, FEV1 z-scores, and ACQ-7-IA scores were noted in both subgroups, with greater numerical improvements in severe asthma.
Conclusions:
- Long-term dupilumab treatment improves lung function and asthma control in children with type 2 asthma.
- Efficacy was observed irrespective of baseline disease severity.
- Numerically greater improvements were seen in children with severe 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.
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