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.