DUPIXENT WAS STUDIED IN CHILDREN
WITH MODERATE-TO-SEVERE ASTHMA
AGED 6-11 YEARS1,2
VOYAGE (n=408), 52 weeks
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)
Children (aged 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
Children with markers of type 2 inflammation:
- Blood EOS ≥300 cells/µL
- Blood EOS ≥150 cells/µL or FeNO ≥20 ppb
Annualized rate of severe exacerbations during the 52-week placebo-controlled treatment period
Mean change from baseline at Week 12 in percent predicted pre-bronchodilator FEV1
- Change from baseline in percent predicted pre-bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52 and other time points
- ACQ-7-IA
- PAQLQ(S)-IA
- Use of reliever medication and systemic corticosteroids
- Nocturnal awakenings due to asthma symptoms requiring reliever medication
Selected demographic and baseline characteristics1,2
- Children with EOS ≥150 cells/μL or FeNO ≥20 ppb: Mean age: 9 years; body weight at baseline ≥30 kg: 68%; body weight at baseline <30 kg: 32%; mean duration of asthma: 5.6 years; mean number of exacerbations in previous year: 2.5; percent predicted pre-bronchodilator FEV1 at baseline: 78%; mean baseline blood eosinophil count: 570 cells/μL; mean FeNO: 31 ppb; and mean total IgE: 906 IU/mL
- Children with EOS ≥300 cells/μL: Mean age: 9 years; body weight at baseline ≥30 kg: 67.6%; body weight at baseline <30 kg: 32.4%; mean duration of asthma: 5.7 years; mean number of exacerbations in previous year: 2.6; percent predicted pre-bronchodilator FEV1 at baseline: 77%; mean baseline blood eosinophil count: 710 cells/μL; mean FeNO: 34 ppb; and mean total IgE: 1077 IU/mL
ACQ-7-IA, Asthma Control Questionnaire, Interviewer Administered version; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroids; PAQLQ(S)-IA, Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered; Q2W, once every 2 weeks.