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The Largest Clinical Development Program in Atopic Dermatitis

The DUPIXENT clinical development program for uncontrolled moderate-to-severe atopic dermatitis included over 2700 patients across 5 pivotal trials.1

CHILDREN
6-11 years of age,
DUPIXENT + TCS
ADOLESCENTS
12-17 years of age,
DUPIXENT Monotherapy
ADULTS
18+ years of age,
DUPIXENT Monotherapy and + TCS
NUMBER OF
PATIENTS		 367 251 >2100
PIVOTAL
TRIALS

1 Concomitant TCS
(Trial 8: 16 weeks)

1 Monotherapy
(Trial 6: 16 weeks)

2 Monotherapy
(Trials 1 and 2: 16 weeks)

1 Concomitant TCS
(Trial 3: 52 weeks)
NUMBER OF
PATIENTS		 PIVOTAL
TRIALS
CHILDREN
6-11 years of age, DUPIXENT + TCS
 367

1 Concomitant TCS
(Trial 8: 16 weeks)
ADOLESCENTS
12-17 years of age, DUPIXENT Monotherapy
 251

1 Monotherapy
(Trial 6: 16 weeks)
ADULTS
18+ years of age, DUPIXENT Monotherapy and + TCS
 >2100

2 Monotherapy
(Trials 1 and 2: 16 weeks)

1 Concomitant TCS
(Trial 3: 52 weeks)

Study Designs

A robust clinical development program in 3 diseases driven in part by Type 2 inflammation

For Adults

For Adolescents

For Children

Peak Pruritus NRS Efficacy Results

Significant itch relief

In Adults

In Adolescents

In Children

IGA Efficacy Results

Clear or almost-clear skin

In Adults

In Adolescents

In Children

EASI Efficacy Results

Improvement in lesion extent and severity

In Adults

In Adolescents

In Children

Real-world Results

Clinical trial outcomes supported by real-world data1-3

In Adults

Adult Safety Profile

Demonstrated safety
across 52 weeks in adults1

The Week 52 safety profile of DUPIXENT + TCS in adults was generally consistent with Week 16 in adults. The most common adverse reactions (incidence ≥1% at Week 16) in adult patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.1

Review the Adult Safety Data

Adolescent Safety Profile

Long-term Safety
Observed in Adolescents

The long-term safety of DUPIXENT in adolescents was assessed in an open-label extension trial (Trial 7) through Week 521

  • The safety profile at Week 52 was similar to the safety profile observed at Week 16 in Trial 6 (adolescent trial) and in all 3 adult trials
  • The safety profile through Week 16 and Week 52 in adolescents was consistent with that seen in adults

Review the Adolescent Safety Data

Safety Profile in Children

Long-term Safety
Observed in Children

The long-term safety of DUPIXENT + TCS in children was assessed in an open-label extension study (Trial 7) through Week 52

  • The safety profile in subjects followed through Week 52 was similar to the safety profile observed through Week 16 in Trial 8 (trial in children)
  • The long-term safety profile of DUPIXENT + TCS in children was consistent with that seen in adults and adolescents with atopic dermatitis

Review the Safety Data in Children

Dosing and
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Reference:
  1. DUPIXENT Prescribing Information.
  2. Guttman-Yassky E, Lio PA, Mallya UG, et al. Real-world effectiveness of dupilumab in atopic dermatitis: improvement in itch as assessed by the peak pruritus numerical rating scale (PNRS) in an electronic medical records dataset. Paper presented at: 24th World Congress of Dermatology (WCD); June 10-15, 2019; Milan, Italy.
  3. Eichenfield LF, Gadkari A, Armstrong AW, et al. Real-world effectiveness of dupilumab based on Investigator Global Assessment (IGA) scores and Peak Pruritus Numerical Rating Scale (PNRS) in an electronic medical records dataset. Poster presented at: 77th Annual Meeting of the Society for Investigative Dermatology (SID); May 8-11, 2019; Chicago, IL.