VOYAGE ENROLLED >400 CHILDREN
AGED 6-11 WITH MODERATE-TO-
SEVERE ASTHMA THROUGH YEAR 11-3
VOYAGE (N=408), 52 weeks
Study objective
- To evaluate efficacy and safety of DUPIXENT in children aged 6-11 years with uncontrolled, moderate-to-severe asthma
Study design
- 52-week, randomized, double-blind, placebo-controlled phase 3 study
a In pediatric patients aged 6-11, the recommended dosage of DUPIXENT is 300 mg Q4W for children 15 kg to <30 kg and 200 mg Q2W for children weighing ≥30 kg.
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 periodb
Mean change from baseline at Week 12 in percent predicted pre-bronchodilator FEV1
- Change from baseline in percent predicted pre-bronchodilator FEV1 assessed at Weeks 2, 4, 8, 24, 36, and 52 and other time points
- ACQ-7-IA
- PAQLQ(S)-IA
- Use of reliever medication and SCS
- Nocturnal awakenings due to asthma symptoms requiring reliever medication
b Severe exacerbations were defined as deterioration of asthma requiring the use of SCS for at least 3 days or hospitalization or ED visit due to asthma that required SCS.3
Selected demographic and baseline characteristics2
- 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 EOS 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 EOS count: 710 cells/μL; mean FeNO: 34 ppb; and mean total IgE: 1077 IU/mL
>360 children aged 6-11 with moderate-to-severe asthma continued into EXCURSION OLE through Year 24
EXCURSION (n=365), 52 Weeks
Study objective
- To evaluate the long-term safety and efficacy of DUPIXENT in children aged 6-11 with moderate-to-severe asthma who previously participated in the VOYAGE study
Study design
- 52-week OLE study
Of the 408 children in the VOYAGE parent study, 365 (90%) enrolled in EXCURSION (overall population). Enrollment in EXCURSION was voluntary (43 children did not enter). Of the 365 children, 240 who received DUPIXENT during VOYAGE continued DUPIXENT in EXCURSION (DUPIXENT/DUPIXENT group), and 125 children who were on placebo during VOYAGE initiated DUPIXENT in EXCURSION for up to 52 weeks (placebo/DUPIXENT group).
DUPIXENT dose
DUPIXENT + SOC for 52 weeks
In children ≤30 kg: 100 mg Q2W or 300 mg Q4W
DUPIXENT + SOC for 52 weeks
In children >30 kg: 200 mg Q2W
- Children (aged 6-11) with moderate-to-severe asthma who completed the treatment period in VOYAGE
- Subjects were on a background of medium-dose ICS with a second controller medication or high-dose ICS with or without a second controller medication
- Number and percentage of children experiencing any TEAEs by up to week 52 of the OLE study
Secondary endpoints
- Annualized rate of severe asthma exacerbation events
- Mean change from PSBL in percent predicted pre-bronchodilator FEV1 at Week 52
cAfter a protocol amendment in December 2019, for children ≤30 kg who received DUPIXENT 100 mg Q2W in the parent study and were >8 weeks from completing the treatment period, the DUPIXENT dose was changed to 300 mg Q4W.
There are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, potential continued involvement of responders, and attrition of nonresponders. The number of patients enrolled from the United States was relatively low (n=44) compared with the overall trial population. Thus, conclusions on the racial and ethnic subgroups of the United States are difficult to make due to the smaller numbers of patients enrolled. This limitation should be considered when generalizing findings to the wider population of children with asthma.
Selected demographic and baseline characteristics4
- DUPIXENT/DUPIXENT (n=240): Mean age: 8.9 years; mean weight: 35.4 kg; mean number of exacerbations in previous year: 2.6; high-dose ICS use: 43.5%; percent predicted pre-bronchodilator FEV1 at Week 0: 76.9%; mean baseline blood EOS count: 550 cells/μL; mean FeNO: 30 ppb; and mean total IgE: 832 IU/mL
- Placebo/DUPIXENT (n=125): Mean age: 8.9 years; mean weight: 36.7 kg; mean number of exacerbations in previous year: 2.2; high-dose ICS use: 46%; percent predicted pre-bronchodilator FEV1 at Week 0: 78.7%; mean baseline blood EOS count: 450 cells/μL; mean FeNO: 25 ppb; and mean total IgE: 676 IU/mL
ACQ-7-IA, Asthma Control Questionnaire, Interviewer Administered version; ED, emergency department; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; OLE, open-label extension; PAQLQ(S)-IA, Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered; PSBL, parent study baseline; Q2W, once every 2 weeks; Q4W, once every 4 weeks; SCS, systemic corticosteroid; TEAE, treatment-emergent adverse event.
EXPLORE THE EFFICACY
DATA AND SAFETY DATA
FOR CHILDREN (AGED 6-11)
Dosage and Administration
See the multiple dosage and administration options for patients on DUPIXENT.