Skip to main content

EFFICACY IN CHILDREN (AGED 6-11)

Open Up a World
BEYOND THEIR ASTHMA SYMPTOMS

DUPIXENT was proven to significantly improve
and sustain lung function in children aged 6-11

Open Up a World
BEYOND THEIR ASTHMA SYMPTOMS

DUPIXENT is proven to significantly improve and sustain lung function in children aged 6-11

DUPIXENT significantly reduced exacerbations in children aged 6-11 through Year 11

VOYAGE

Annualized rate of severe exacerbations through Week 52 in eosinophilic
phenotype VOYAGE (primary endpoint)1,2,a

Weight-based dosing: DUPIXENT 100 mg Q2W (<30 kg) or 200 mg Q2W (≥30 kg).1

aSevere 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.1

EXCURSION OLE
95%

reduction

in unadjusted annualized severe exacerbation rate in patients who enrolled in EXCURSION OLE (DUPIXENT/DUPIXENT group [rate: 0.118; n=209]) from PSBL through Year 2 in patients with moderate-to-severe asthma (EOS count ≥150 cells/μL or FeNO ≥20 ppb) (PSBL rate: 2.56) (secondary endpoint)3,b

  • 94% reduction in unadjusted annualized severe exacerbation rate in patients who enrolled in EXCURSION OLE (placebo/​DUPIXENT group [rate: 0.124; n=106]) from PSBL through Year 2 in patients with moderate-to-severe asthma (EOS count ≥150 cells/μL or FeNO ≥20 ppb) (PSBL rate: 2.16) (secondary endpoint)3
ZERO

EXACERBATIONS IN 91% OF CHILDREN AGED
6-11 THROUGH YEAR 2 (EXCURSION OLE)3,c

EXCURSION OLE results are descriptive. Definitive conclusions cannot be made.

Data were not multiplicity controlled, and there are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of nonresponders.

bSevere exacerbation was defined as an event requiring SCS for ≥3 days, hospitalization, or an ED visit.3

cMost children (286 [91%] of 315) remained exacerbation-free throughout the study.3

DUPIXENT sustained lung function improvement in children
aged 6-11 through Year 11

VOYAGE
2X
improvement was seen with DUPIXENT at Week 12
in percent predicted pre-bronchodilator
FEV1 vs placebo (key secondary endpoint)1,2
  • 5.21% improvement in percent predicted pre-bronchodilator FEV1 in children aged 6-11 with EOS ≥150 cells/μL or FeNO ≥20 ppb
    at Week 12 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=229) vs placebo + SOC (n=110)
  • 5.32% improvement in percent predicted pre-bronchodilator FEV1 in children aged 6-11 with EOS ≥300 cells/μL (n=175) at Week 12 with
    DUPIXENT 100 mg/200 mg Q2W + SOC (n=168) vs placebo + SOC (n=80)
3X
improvement was seen with DUPIXENT at Week 52
in percent predicted pre-bronchodilator
FEV1 vs placebo (other secondary endpoint)1,2
  • 7.79% LSM improvement in percent predicted pre-bronchodilator FEV1 in children with EOS ≥150 cells/μL or FeNO ≥20 ppb (n=236)
    at Week 52 with DUPIXENT 100 mg/200 mg Q2W + SOC vs placebo + SOC (n=114)
  • 8.35% LSM improvement in percent predicted pre-bronchodilator FEV1 in children with EOS ≥300 cells/μL (n=175) at Week 52 with
    DUPIXENT 100 mg/200 mg Q2W + SOC vs placebo + SOC (n=84)
VOYAGE
(post hoc analysis)

Exacerbation reduction observed in lung function responders4

60%

risk reduction
in severe exacerbations4,d

Children treated with DUPIXENT vs placebo who had a ≥5% improvement in percent predicted pre-bronchodilator FEV1 at Week 12 showed a 60% risk reduction in severe exacerbation rates.

In VOYAGE:

  • In children with blood EOS ≥150 cells/μL or FeNO ≥20 ppb who achieved ≥5% improvement in percent predicted pre-bronchodilator FEV1 at Week 12, the adjusted annualized severe exacerbation rate through Week 52 was 0.251 in the DUPIXENT 100 mg/200 mg Q2W + SOC group (n=141) and 0.626 in the placebo + SOC group (n=57) (reduction in relative risk vs matching placebo: 60.0% [95% CI: 0.16, 0.41])
  • In children with blood EOS ≥150 cells/μL or FeNO ≥20 ppb who achieved ≥10% improvement in percent predicted pre-bronchodilator FEV1 at Week 12, the adjusted annualized severe exacerbation rate through Week 52 was 0.304 in the DUPIXENT 100 mg/200 mg Q2W + SOC group (n=106) and 0.744 in the placebo + SOC group (n=36) (reduction in relative risk vs matching placebo: 59.0% [95% CI: 0.19, 0.50])

Results are descriptive. Definitive conclusions cannot be made as this was a post hoc analysis. There are limitations on sample size, and data were not multiplicity controlled.

DUPIXENT was proven to significantly improve and sustain lung function in children aged 6-113

dSevere exacerbation was defined as an event requiring SCS for ≥3 days, hospitalization, or an ED visit.2

Results in lung function improvement in children aged 6-11
through Year 23

EXCURSION OLE

Change from PSBL in percent predicted pre-bronchodilator FEV1 over time in children with blood EOS count ≥150 cells/µL or FeNO ≥20 ppb at PSBL (secondary endpoint)

EXCURSION OLE results are descriptive. Definitive conclusions cannot be made.

Data were not multiplicity controlled and there are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of nonresponders.

  • At PSBL, mean percent predicted pre-bronchodilator FEV1 was 76.9% in the DUPIXENT/DUPIXENT group (n=209) and 78.7% in the placebo/DUPIXENT group (n=106)
  • In patients initiated with placebo who switched to DUPIXENT (n=106) at Week 52 of VOYAGE, rapid improvement in percent predicted pre-bronchodilator FEV1 was observed as early as Week 2 (mean change from baseline: 8.7%, secondary endpoint)
  • By Week 52 in EXCURSION, percent predicted pre-bronchodilator FEV1 improvement results from baseline were 12.6% in the DUPIXENT/DUPIXENT group (n=209) and 9.4% in the placebo/DUPIXENT group (n=106) (secondary endpoint)

78% of children who continued on DUPIXENT had percent predicted pre-bronchodilator FEV1 ≥80% by the end of Year 2e

e(n=143/184) measured as percent predicted pre-bronchodilator FEV1 ≥80% by Week 52.

DUPIXENT reduced systemic corticosteroid use in children aged 6-112

~50% of children aged 6-12 were reported to receive SCS bursts for asthma in the previous 3 months in an observational study (n=770)2,f
VOYAGE
59%

reduction in SCS courses in children with EOS ≥150 cells/μL or FeNO ≥20 ppb through Year 1 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=236) vs placebo + SOC (n=114) (adjusted annualized total SCS courses in all patients: 0.35 [95% CI: 0.26, 0.48] vs 0.86 [95% CI: 0.62, 1.20]) (secondary endpoint)1,2

66%

reduction in SCS courses in children with EOS ≥300 cells/μL through Year 1 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=175) vs placebo + SOC (n=84) (adjusted annualized total SCS courses in all patients: 0.27 [95% CI: 0.19, 0.40] vs 0.81 [95% CI: 0.56, 1.15]) (secondary endpoint)1,2

EXCURSION OLE (post hoc analysis)
ZERO

RESCUE SCS USE in 81% of children aged 6-11
through Year 2 who had 1 severe prior exacerbation
(DUPIXENT/DUPIXENT, n=77)6

Zero rescue SCS use through Year 2:

  • In 70% of children aged 6-11 who had 1 severe prior exacerbation (placebo/​DUPIXENT, n=43)
  • In 66% of children 6-11 who had ≥2 severe prior exacerbations (DUPIXENT/​DUPIXENT, n=132)
  • In 54% of children aged 6-11 who had ≥2 severe prior exacerbations (placebo/​DUPIXENT, n=63)

EXCURSION OLE results are descriptive. Definitive conclusions cannot be made as this was a post hoc analysis of open-label extension data.

Data were not multiplicity controlled, and there are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of nonresponders.

fTENOR was a 3-year, multicenter, observational study of 4756 patients with severe or difficult-to-treat asthma, including 770 children aged 6-12.5

DUPIXENT improved asthma
control in children aged 6‑112

DUPIXENT IMPROVED
ASTHMA CONTROL RESULTS,
AS MEASURED BY ACQ-7-IA7,g

EOS ≥150 cells/μL or FeNO ≥20 ppb
(eosinophilic phenotype)
  • 79% responder rate vs 69% responder rate in the placebo
    group at Week 24 with DUPIXENT 100 mg/200 mg Q2W + SOC
    (n=236) vs placebo + SOC (n=114) (OR: 1.82 [95% CI: 1.02,
    3.24]) (other secondary endpoint)
EOS ≥300 cells/μL
  • 81% responder rate vs 64% responder rate in the placebo
    group at Week 24 with DUPIXENT 100 mg/200 mg Q2W + SOC
    (n=175) vs placebo+ SOC (n=84) (OR: 2.79 [95% CI: 1.43, 5.44])
    (other secondary endpoint)

Results are descriptive. Definitive conclusions cannot be made. There are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of nonresponders.

gA responder was defined as a patient with a reduction of ≥0.5 in
ACQ-7-IA score from baseline (minimal clinically important difference
for this outcome).7

ACQ-7-IA: Asthma Control Questionnaire, Interviewer Administered
version: Children 6-16 years respond to 6 questions about symptoms,
lung function, and medication use on a 7-point scale (0=no
impairment; 6=maximum impairment). Lower scores indicate better
asthma control. The minimal clinically important difference is 0.5.1,8

ED, emergency department; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; LSM, least squares mean; OLE, open-label extension; OR, odds ratio; PAQLQ(S)-IA, Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered; PSBL, parent study baseline; Q2W, once every 2 weeks; SCS, systemic corticosteroid; SOC, standard of care.

EXPLORE THE SAFETY DATA AND STUDY DESIGN FOR CHILDREN (AGED 6-11)

VIEW safety data VIEW STUDY DESIGN

Dosage and Administration

See the multiple dosage and administration options for patients on DUPIXENT.

EXPLORE ADMINISTRATION OPTIONS