Open Up a World
BEYOND THEIR ASTHMA SYMPTOMS
DUPIXENT was proven to significantly improve and sustain lung function in children aged 6-11 years1-3
DUPIXENT significantly reduced exacerbations in children aged 6-11 years through Year 11
Annualized rate of severe exacerbations through Week 52 in
eosinophilic phenotype
VOYAGE (primary endpoint)1,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
Results in severe exacerbation reduction in children aged 6-11 years through Year 22
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)2,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)2
EXACERBATIONS IN 91% OF CHILDREN AGED
6-11 years THROUGH YEAR 2 (EXCURSION OLE)2,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.2
cMost children (286 [91%] of 315) remained exacerbation-free throughout the study.2
ED, emergency department; EOS, eosinophil; FeNO, fractional exhaled nitric oxide; OLE, open-label extension; PSBL parent study baseline; Q2W, once every 2 weeks; QoL, quality of life; SCS, systemic corticosteroid; SOC, standard of care.
DUPIXENT sustained lung function improvement in children
aged 6-11 years through Year 13
improvement was seen with DUPIXENT at Week 12
in percent predicted pre-bronchodilator
FEV1 vs placebo (key secondary endpoint)1
-
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)
improvement was seen with DUPIXENT at Week 52
in percent predicted pre-bronchodilator
FEV1 vs placebo (other secondary endpoint)1
-
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)
(post hoc analysis)
Exacerbation reduction observed in lung function responders4
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 VOYAGE4:
- 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.
dSevere exacerbation was defined as an event requiring SCS for ≥3 days, hospitalization, or an ED visit.2
DUPIXENT was proven to significantly improve and sustain lung function in children aged 6-11 years2
DUPIXENT lung function improvement results in children aged 6-11 years through Year 22
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)2
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)2
- 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)2
- 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)2
78% of children who continued on DUPIXENT had percent predicted pre-bronchodilator FEV1 ≥80% by the end of Year 22,e
e(n=143/184) measured as percent predicted pre-bronchodilator FEV1 ≥80% by Week 52.2
EOS, eosinophil; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; LSM, least squares mean; OLE, open-label extension; PSBL parent study baseline; Q2W, once every 2 weeks; QoL, quality of life; SCS, systemic corticosteroid SOC, standard of care.
DUPIXENT reduced SCS use in children aged 6-11 years2
~50% of children aged 6-12 years were reported to receive SCS bursts for asthma in the previous 3 months in an observational study (n=770)5,f
VOYAGE
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
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)
RESCUE SCS USE in 81% of children aged 6-11 years
through Year 2 who had 1 severe prior exacerbation
(DUPIXENT/DUPIXENT, n=77)6
Zero rescue SCS use through Year 26:
- In 70% of children aged 6-11 years who had 1 severe prior exacerbation (placebo/DUPIXENT, n=43)
- In 66% of children 6-11 years who had ≥2 severe prior exacerbations (DUPIXENT/DUPIXENT, n=132)
- In 54% of children aged 6-11 years 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
EOS, eosinophil; FeNO, fractional exhaled nitric oxide; OLE, open-label extension; Q2W, once every 2 weeks; QoL, quality of life; SCS, systemic corticosteroid; SOC, standard of care.
Asthma control data in children
DUPIXENT IMPROVED
ASTHMA CONTROL RESULTS,
AS
MEASURED BY ACQ-7-IA1,7,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 aged 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 0.5.7,8
Not an actual DUPIXENT patient.
Quality of life data in children
of children aged 6-11 years experienced an improved
quality of life, as measured by PAQLQ(S)-IA1,7
- 73% of children improved their quality of life at Week 24 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=211) vs 65% with placebo + SOC (n=107)
- 73% of children improved their quality of life at Week 24 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=158) vs 63% with placebo + SOC (n=81)
PAQLQ(S)-IA was studied in children aged ≥7 to <12 years.1
Results are descriptive. Definitive conclusions cannot be made. Analysis of change at Week 24 was not multiplicity controlled. 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.
PAQLQ(S)-IA: Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered: Children aged ≥7 to <12 years at randomization responded to questions about health-related quality of life on a 7-point scale (7=no impairment; 1=severe impairment) at Weeks 12, 24, 36, and 52. The ability of DUPIXENT to impact health-related quality of life was assessed by evaluating the LSM change in PAQLQ(S)-IA scores.1,7
EOS, eosinophil; FeNO, fractional exhaled nitric oxide; LSM, least squares mean; OR, odds ratio; Q2W, once every 2 weeks; QoL, quality of life; SCS, systemic corticosteroid; SOC, standard of care.
EXPLORE THE SAFETY DATA AND STUDY DESIGN FOR CHILDREN (AGED 6-11 years)
Dosage and Administration
See the multiple dosage and administration options for patients on DUPIXENT.