SIGNIFICANTLY REDUCED EXACERBATIONS THROUGH 1 YEAR

Significant exacerbation reduction in pediatric patients (6‑11 years) with type 2 inflammatory
biomarkers1,a

ANNUALIZED SEVERE EXACERBATION REDUCTION THROUGH WEEK 52 IN
EOSINOPHILIC PHENOTYPE (PRIMARY ENDPOINT)

Weight-based dosing: DUPIXENT 100 mg Q2W (≤30 kg) or 200 mg Q2W (> 30 kg)

aSevere exacerbations were defined as deterioration of asthma requiring the use of systematic corticosteriods for at least 3 days or hospitalization or emergency department visit due to asthma that required systemic corticosteriods.2

RAPID AND SUSTAINED BREATHING RELIEF1

Significant improvement in lung function observed at Week 2, maintained at Week 52

MEAN CHANGE FROM BASELINE IN PERCENT PREDICTED FEV1 THROUGH WEEK 52 (OTHER SECONDARY ENDPOINT)

Significant improvement in lung function observed at Week 2, maintained at Week 52

Weight-based dosing: DUPIXENT 100 mg Q2W (≤30 kg) or 200 mg Q2W (> 30 kg)

b Eosinophilic phenotype.

Percent predicted pre-BD FEV1 at Week 12 (key secondary endpoint)

  • 5.21% improvement in percent predicted pre-BD FEV1 vs placebo in pediatric patients (6‑11 years) with EOS ≥150 cells/μL or FeNO ≥20 ppb
    (eosinophilic phenotype) at Week 12 with DUPIXENT 100 mg/200 mg Q2W + SOC vs placebo + SOC1
  • 5.32% improvement in percent predicted pre-BD FEV1 vs placebo in pediatric patients (6‑11 years) with EOS ≥300 cells/μL at Week 12 with DUPIXENT
    100 mg/200 mg Q2W + SOC vs placebo + SOC1

REDUCED SYSTEMIC STEROID USE AND IMPROVED ASTHMA CONTROL

SCS reduction through Week 52 in eosinophilic phenotype

EOS ≥150 cells/μL or FeNO ≥20 ppb

in SCS courses in pediatric patients 6‑11 years 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]) (VOYAGE, other secondary endpoint)1

EOS ≥300 cells/µL

in SCS courses in pediatric patients 6‑11 years 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]) (VOYAGE, other secondary endpoint)1

IMPROVED ASTHMA CONTROL AND QUALITY OF LIFE

Significantly improved asthma control at Week 24, as measured by ACQ-7-IA1,c

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) (odds ratio: 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) (odds ratio: 2.79 [95% CI: 1.43, 5.44]) (other secondary endpoint)

A 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).

Improved quality of life, as measured by PAQLQ(S)-IA1,d,e

EOS ≥150 cells/μL or FeNO ≥20 ppb (eosinophilic phenotype)

  • 0.34-point LSM difference vs placebo at Week 52 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=211) vs placebo + SOC (n=107) (95% CI: 0.16, 0.52)

EOS ≥300 cells/µL

  • 0.33-point LSM difference vs placebo at Week 52 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=158) vs placebo + SOC (n=81) (95% CI: 0.12, 0.53)

c ACQ-7-IA: Asthma Control Questionnaire, Interviewer Administered version: Pediatric patients (6-16 years) respond to 7 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 0.5.1,3

d PAQLQ(S)-IA: Pediatric Asthma Quality of Life Questionnaire With Standardized Activities-Interviewer Administered: Pediatric patients (≥7 to <12 years) 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 score at randomization.1

e Analysis of change at Week 52 was not multiplicity controlled; result is descriptive.

BD, bronchodilator; BL, baseline; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; IA, interviewer administered; ICS, inhaled corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks; SCS, systemic corticosteroid; SOC, standard of care; TEAE, treatment-emergent adverse event.

EXPLORE THE EFFICACY DATA AND SAFETY DATA IN PEDIATRIC PATIENTS (6-11 YEARS)

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