First and only biologic approved to treat uncontrolled moderate-to-severe atopic dermatitis from infancy to adulthood (6+ months
of age)1

DUPIXENT was studied in over 2800 patients across 6 pivotal trials that included monotherapy and concomitant TCS1

Infants to Preschoolers
6 months to 5 years
of age
DUPIXENT + TCS
Number
of Patients		 162
Pivotal
Trials		 1 Concomitant TCS
(AD-1539: 16 weeks)

 

Children
6-11 years of age
DUPIXENT + TCS
Number
of Patients		 367
Pivotal
Trials		 1 Concomitant TCS
(AD-1652: 16 weeks)

 

ADOLESCENTS
12-17 years of age
DUPIXENT Monotherapy
Number
of Patients		 251
Pivotal
Trials		 1 Monotherapy
(AD-1526: 16 weeks)

 

Adults
18+ years of age
DUPIXENT Monotherapy or + TCS
Number
of Patients		 >2100
Pivotal
Trials		 2 Monotherapy
(SOLO 1 and SOLO 2: 16 weeks)
1 Concomitant TCS
(CHRONOS: 52 weeks)

In atopic dermatitis, clinically meaningful improvement was seen at Week 16 in concomitant TCS trials in adults, children, and infants to preschoolers1-4,a,b

In atopic dermatitis, improvement was seen at Week 16 in monotherapy trials in adults and adolescents1,5,6,a,b

The results presented are not intended to be comparative among the child, adolescent, and adult DUPIXENT trials.

EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; Q4W, once every 4 weeks; TCS, topical corticosteroids.

a Full Analysis Set includes all subjects randomized.1

b In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.1

c In CHRONOS, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.1

d At Day 1, subjects (baseline weight <30 kg) received 600 mg of DUPIXENT.1

e At Day 1, subjects (baseline weight ≥30 kg) received 400 mg of DUPIXENT.1

f Infants to preschoolers 15 kg but <30 kg received 300 mg Q4W, and infants to preschoolers 5 kg but <15 kg received 200 mg Q4W.1

g IGA scale was defined as 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.1

h Data analyses reflect patients with baseline Peak Pruritus NRS score ≥4. In SOLO 1, DUPIXENT (n=213) and placebo (n=212). In SOLO 2, DUPIXENT (n=225) and placebo
(n=221). In CHRONOS, DUPIXENT + TCS (n=102) and placebo + TCS (n=299).3,5

Demonstrated long-term safety profile

The Week 52 safety profile of DUPIXENT + TCS in adults was generally consistent with Week 16 in adults.1

The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.1

The safety profile in pediatric patients through Week 16 (in pivotal trials) and Week 52 (in an open-label extension trial, AD-1434) was consistent with that of adults with atopic dermatitis. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.1

Study designs

Studied in 6 pivotal trials in uncontrolled moderate-to-severe atopic dermatitis

Itch relief

Peak Pruritus NRS (adults, adolescents, and children) Worst Scratch/Itch NRS (infants to preschoolers)

Skin clearance

IGA

Improvement in lesion extent and severity

EASI-75

Real-world results

Data from 3 real-world studies of patients treated with DUPIXENT

Dosage and Administration
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