Evaluated in 162 infants to preschoolers (6 months to 5 years of age) in AD-1539

Clinical trials in infants to preschoolers included 1 trial with concomitant TCS (AD-1539) and 1 open-label extension trial (AD-1434). In AD-1539, patients were initiated with 1 DUPIXENT (200 mg or 300 mg) dose or placebo (subcutaneous injection) at Week 0 followed by 1 DUPIXENT (200 mg or 300 mg) dose or placebo every 4 weeks, based on the child’s weight. No initial loading dose was required. In AD-1434, the dose of DUPIXENT was 200 mg or 300 mg.1

Disease severity was defined by an IGA score of ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1,2

Infants to preschoolers (6 months to 5 years of age)1,2

Number
of patients

162

Pivotal
trial

1 double-blind DUPIXENT vs placebo; all patients received concomitant TCS 
(AD-1539: 16 weeks) 

Dosinga

5 kg to <15 kg: 200 mg Q4W 

≥15 kg to <30 kg: 300 mg Q4W

BASELINE disease severityb

Moderate
disease 
(IGA 3)


Severe disease
(IGA 4)


Mean EASI


Mean Worst Scratch/Itch NRSc

23%


77%


34


7.6

aFor patients 6 months to 5 years of age with atopic dermatitis, no initial loading dose is recommended.

bMean disease duration was 3.4 years for infants to preschoolers. Mean age was 3.8 years for infants to preschoolers.1,2

cWeekly average of Worst Scratch/Itch NRS score (10 indicates the most severe).

Primary endpoint in the study with infants to preschoolers was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 161
Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%) and itch reduction defined by ≥4-point improvement in the Worst Scratch/Itch NRS at Week 16.1

EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q4W, once every 4 weeks;  SC, subcutaneous; TCS, topical corticosteroids.

Infants to preschoolers (6 months to 5 years of age)1,2

Number
of patients

162

Pivotal
trial

1 double-blind DUPIXENT vs placebo; all patients received concomitant TCS 
(AD-1539: 16 weeks) 

Dosinga

5 kg to <15 kg: 200 mg Q4W 

≥15 kg to <30 kg: 300 mg Q4W

BASELINE disease severityb

Moderate
disease 
(IGA 3)

23%

Severe disease
(IGA 4)

77%

Mean EASI

34

Mean Worst Scratch/Itch NRSc

7.6

aFor patients 6 months to 5 years of age with atopic dermatitis, no initial loading dose is recommended.

bMean disease duration was 3.4 years for infants to preschoolers. Mean age was 3.8 years for infants to preschoolers.1,2

cWeekly average of Worst Scratch/Itch NRS score (10 indicates the most severe).

Primary endpoint in the study with infants to preschoolers was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 161
Other endpoints included change from baseline in the proportion of subjects with EASI-75 at Week 16 (improvement of ≥75%) and itch reduction defined by ≥4-point improvement in the Worst Scratch/Itch NRS at Week 16.1

EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q4W, once every 4 weeks;  SC, subcutaneous; TCS, topical corticosteroids.