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The Largest Clinical Development Program in Atopic Dermatitis

The DUPIXENT clinical development program included ≈6000 patients across 9 pivotal trials1,a

ATOPIC DERMATITIS
18+ years of age
ATOPIC DERMATITIS
12-17 years of age
ASTHMA
12+ years of age (eosinophilic phenotype or OCS dependent)
CRSwNP
18+ years of age
NUMBER OF
PATIENTS		 >2100 251 2888 724
PIVOTAL
TRIALSa

2 Monotherapy
(Trials 1 and 2)

1 Concomitant TCS
(Trial 3)

1 Monotherapy
(Trial 6)

2 Concomitant SOC
(Trials 1b and 2)

1 Concomitant SOC
+ OCS (Trial 3)

2 Concomitant SOC
(Trials 1 and 2)
NUMBER OF
PATIENTS		 PIVOTAL
TRIALSa
ATOPIC
DERMATITIS
18+ years
of age
 >2100

2 Monotherapy (Trials 1 and 2)

1 Concomitant TCS (Trial 3)
ATOPIC
DERMATITIS
12-17 years
of age
 251

1 Monotherapy (Trial 6)
ASTHMA
12+ years
of age
(eosinophilic
phenotype or
OCS dependent)
 2888

2 Concomitant SOC (Trials 1b and 2)

1 Concomitant SOC + OCS (Trial 3)
CRSwNP
18+ years
of age
 724

2 Concomitant SOC (Trials 1 and 2)
  • aIn atopic dermatitis, Trial 4 was a dose-ranging trial to evaluate the safety of DUPIXENT monotherapy through Week 16. In atopic dermatitis, Trial 5 evaluated multiple DUPIXENT monotherapy dose regimens for maintaining treatment response for 36 weeks.
  • bTrial 1 studied patients aged 18 years and older.

Study Designs

The largest clinical development program in atopic dermatitis

For Adults

For Adolescents

Peak Pruritus NRS Efficacy Results

Significant itch relief

In Adults

In Adolescents

IGA Efficacy Results

Clear or almost-clear skin

In Adults

In Adolescents

EASI Efficacy Results

Improvement in lesion extent and severity

In Adults

In Adolescents

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 long-term safety profile in adolescents was consistent with that seen in adults

Review the Adolescent Safety Data

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Reference:
  1. DUPIXENT Prescribing Information.