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

up to
73%

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.