First and only biologic approved to treat uncontrolled
moderatetosevere atopic dermatitis from infancy to adulthood1

DUPIXENT was studied in over 3000 patients across 7 pivotal trials that included monotherapy and concomitant TCS1,2

Adults
18+ years of age
DUPIXENT Monotherapy or + TCS
Number
of Patients
>2200
Monotherapy SOLO 1:16 weeks
SOLO 2: 16 weeks
AD-HAFT:
16 weeks
Concomitant
DUPIXENT + TCS
CHRONOS:
52 weeks

 

ADOLESCENTS
12-17 years of age
DUPIXENT Monotherapy
Number
of Patients
278
Monotherapy AD-1526:
16 weeks
AD-HAFT:
16 weeks

 

Children
6-11 years of age
DUPIXENT + TCS
Number
of Patients
367
Concomitant
DUPIXENT
+ TCS
AD-1652:
16 weeks

 

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

First specialty systemic therapy with a phase 3 study in atopic dermatitis patients aged 12+ years with
uncontrolled moderate-to-severe hand and/or foot involvement

ATOPIC DERMATITIS
PATIENTS AGED 12+ YEARS WITH UNCONTROLLED MODERATE-TO-SEVERE
HAND AND/OR FOOT INVOLVEMENT1,2

IMPROVEMENT WAS SEEN AT WEEK 16 IN MONOTHERAPY TRIALS1,3-5,c,d

CLINICALLY MEANINGFUL IMPROVEMENT WAS SEEN AT WEEK 16 IN CONCOMITANT TCS TRIALS1,6-8,c,d

The results presented are not intended to be comparative among the infant to preschooler, 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 IGA and IGA hand and foot scales were defined as 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.3

b Data analyses reflect patients with baseline Peak Pruritus NRS and hand and foot Peak Pruritus NRS score ≥4. In AD-HAFT, DUPIXENT (n=67) and placebo (n=66). 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).1

c Full Analysis Set includes all subjects randomized.1

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

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

f At Day 1, subjects (baseline weight <30 kg) received 600 mg of DUPIXENT1

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

h 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

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

Real-world results

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

VIEW RESULTS IN ADULTS