52-WEEK PEDIATRIC TRIAL (N=408)
Randomized
Subjects were randomized to DUPIXENT (n=273) or matching placebo (n=135) Q2W based on body weight ≤30 kg (100 mg Q2W) or >30 kg (200 mg Q2W)
Study population
Pediatric patients (6-11 years) with moderate-to-severe asthma on a medium-dose ICS with a second controller medication or high-dose ICS with or without a second controller medication
Patients with markers of type 2 inflammation:
- Blood EOS ≥300 cells/µL
- Blood EOS ≥150 cells/µL or FeNO ≥20 ppb
Primary endpoint
Annualized rate of severe exacerbations during the 52-week placebo-controlled treatment period
Key secondary endpoint
Mean change from baseline at Week 12 in percent predicted pre-BD FEV1
Other secondary endpoints
- Change from baseline in percent predicted pre-BD FEV1 at Weeks 2, 4, 8, 24, 36, and 52 and other time points assessed
- Asthma Control Questionnaire, Interviewer Administered Version (ACQ-7-IA)
- Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered [PAQLQ(S)-IA]
- Use of reliever medication and systemic corticosteroids
- Nocturnal awakenings due to asthma symptoms requiring reliever medication
SELECTED DEMOGRAPHICS AND BASELINE CHARACTERISTICS1,2
Mean age
Body weight at baseline >30 kg
Body weight at baseline ≤30 kg
Mean duration of asthma
Mean number of exacerbations
in previous year
Percent predicted pre-BD FEV1
at baseline
Mean baseline blood eosinophil count
Mean FeNO
Mean total IgE
Patients with EOS
≥150 cells/μL or
FeNO ≥20 ppb
9 years
68%
32%
5.6 years
2.5
78%
570 cells/µL
31 ppb
906 IU/mL
Patients with EOS
≥300 cells/µL
9 years
67.6%
32.4%
6 years
2.6
77%
710 cells/µL
34 ppb
1077 IU/mL
| Patients with EOS ≥150 cells/μL or FeNO ≥20 ppb |
Patients with EOS ≥300 cells/µL |
| Mean age | |
| 9 years | 9 years |
| Body weight at baseline >30 kg | |
| 68% | 67.6% |
| Body weight at baseline ≤30 kg | |
| 32% | 32.4% |
| Mean duration of asthma | |
| 5.6 years | 6 years |
| Mean number of exacerbations in previous year | |
| 2.5 | 2.6 |
| Percent predicted pre-BD FEV1 at baseline | |
| 78% | 77% |
| Mean baseline blood eosinophil count | |
| 570 cells/µL | 710 cells/µL |
| Mean FeNO | |
| 31 ppb | 34 ppb |
| Mean total IgE | |
| 906 IU/mL | 1077 IU/mL |
BD, bronchodilator; BL, baseline; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; IA, interviewer administered; ICS, inhaled corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks; SCS, systemic corticosteroid; SOC, standard of care; TEAE, treatment-emergent adverse event.