EFFICACY AND SAFETY OVERVIEW

Lila, 4

Living with moderate‑to‑
severe atopic
dermatitis
since early childhood

Real patient being treated
with DUPIXENT
Individual results may vary

First and only biologic approved to treat uncontrolled
moderate‑to‑severe atopic dermatitis from infancy to adulthood¹

DUPIXENT was studied in over 3000 patients across 7 pivotal trials that included monotherapy and concomitant TCS^1,2

	Adults 18+ years of age DUPIXENT Monotherapy or + TCS	ADOLESCENTS 12-17 years of age DUPIXENT Monotherapy	Children 6-11 years of age DUPIXENT + TCS	Infants to Preschoolers 6 months to 5 years of age DUPIXENT + TCS
Number of Patients	>2200	278	367	162
Monotherapy	SOLO 1: 16 weeks SOLO 2: 16 weeks AD-1526: 16 weeks AD-HAFT: 16 weeks
Concomitant DUPIXENT + TCS	CHRONOS: 52 weeks		AD-1652: 16 weeks	AD-1539: 16 weeks

Adults 18+ years of age DUPIXENT Monotherapy or + TCS
Number of Patients	>2200
Monotherapy	SOLO 1: 16 weeks SOLO 2: 16 weeksAD-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 INVOLVEMENT CLINICAL TRIAL^1,2

Primary endpoint

IGA hand and foot 0
(clear) or 1 (almost
clear) (% of patients)^a

Secondary endpoints

HECSI-75: ≥75%
improvement in hand
lesion extent and
severity (% of patients)

≥4-point improvement
in hand and foot Peak
Pruritus NRS (in
adults^b and
adolescents) (% of
patients)

ADULTS AND ADOLESCENTS
12+ years of age

AD-HAFT MONOTHERAPY

ADULTS
18+ years of age
DUPIXENT monotherapy

SOLO 1

SOLO 2

Primary endpoint

IGA hand and foot 0
(clear) or 1 (almost
clear) (% of patients)^a

Secondary endpoint

HECSI-75: ≥75%
improvement in hand
lesion extent and
severity (% of patients)

Secondary endpoint

≥4-point improvement
in: Peak Pruritus NRS
(in adults^h and adolescents)
(% of patients)

ADOLESCENTS
12-17 years of age
DUPIXENT monotherapy

AD-1526

DUPIXENT (n=67)

Placebo (n=66)

40%
(P=0.0030)

17%

Primary endpoint

≥4-point improvement
in hand and foot Peak
Pruritus NRS (in
adults^b and
adolescents) (% of
patients)

Secondary endpoint

HECSI-75: ≥75%
improvement in hand
lesion extent and
severity (% of patients)

Secondary endpoint

≥4-point improvement
in: Peak Pruritus NRS
(in adults^h and adolescents)
(% of patients)

47%
(P<0.01)

22%

52%
(P<0.0001)

14%

ADULTS AND ADOLESCENTS 12+ years of age
AD-HAFT MONOTHERAPY
DUPIXENT (n=67)	Placebo (n=66)
Primary endpoint
IGA hand and foot 0 (clear) or 1 (almost clear) (% of patients)^a
40% (P=0.0030)	17%
Secondary endpoints
HECSI-75: ≥75% improvement in hand lesion extent and severity (% of patients)
47% P<0.001	22%
≥4-point improvement in hand and foot Peak Pruritus NRS (in adults^b and adolescents) (% of patients)
52% (P<0.0001)	14%

IMPROVEMENT WAS SEEN AT WEEK 16 IN MONOTHERAPY TRIALS^1,3-5,c,d

Primary endpoint

IGA 0 (clear) or 1 (almost clear), and in adults and adolescents ≥2‑point improvement (% of patients)^a

Secondary endpoints

EASI-75: ≥75% improvement in lesion extent and severity
(% of patients)

≥4-point improvement in: Peak Pruritus NRS (in adults^b and adolescents) (% of patients)

DUPIXENT monotherapy

ADULTS
18+ years of age

ADOLESCENTS
12-17 years of age

SOLO 1

SOLO 2

AD-1526

ADULTS
18+ years of age
DUPIXENT monotherapy

SOLO 1

SOLO 2

DUPIXENT
(n=224)

Placebo
(n=224)

DUPIXENT
(n=233)

Placebo
(n=236)

Primary endpoint

IGA 0 (clear) or 1 (almost clear), and in adults and adolescents ≥2‑point improvement (% of patients)^a

Secondary endpoint

EASI-75: ≥75% improvement in lesion extent and severity
(% of patients)

Secondary endpoint

≥4-point improvement
in: Peak Pruritus NRS
(in adults^h and adolescents)
(% of patients)

ADOLESCENTS
12-17 years of age
DUPIXENT monotherapy

AD-1526

DUPIXENT
(n=82)

Placebo
(n=85)

38%
(P<0.001)

10%

36%
(P<0.001)

24%
(P<0.001)

Primary endpoint

IGA 0 (clear) or 1 (almost clear), and in adults and adolescents ≥2‑point improvement (% of patients)^a

Secondary endpoint

EASI-75: ≥75% improvement in lesion extent and severity
(% of patients)

Secondary endpoint

≥4-point improvement
in Peak Pruritus NRS
(in adults^b and adolescents)
(% of patients)

51%
(P<0.001)

15%

44%
(P<0.001)

12%

42%
(P<0.001)

41%
(P<0.001)

12%

36%
(P<0.001)

10%

37%
(P<0.001)

DUPIXENT monotherapy
ADULTS 18+ years of age
SOLO 1		SOLO 2
DUPIXENT (n=224)	Placebo (n=224)	DUPIXENT (n=233)	Placebo (n=236)
Primary endpoint IGA 0 (clear) or 1 (almost clear), and in adults and adolescents ≥2‑point improvement (% of patients)^a
38% (P<0.001)	10%	36% (P<0.001)	9%
Secondary endpoint EASI-75: ≥75% improvement in lesion extent and severity (% of patients)
51% (P<0.001)	15%	44% (P<0.001)	12%
Secondary endpoint ≥4-point improvement in Peak Pruritus NRS (in adults^b and adolescents) (% of patients)
41% (P<0.001)	12%	36% (P<0.001)	10%

DUPIXENT monotherapy
ADOLESCENTS 12-17 years of age
AD-1526
DUPIXENT (n=82)	Placebo (n=85)
Primary endpoint IGA 0 (clear) or 1 (almost clear), and in adults and adolescents ≥2‑point improvement (% of patients)^a
24% (P<0.001)	2%
Secondary endpoint EASI-75: ≥75% improvement in lesion extent and severity (% of patients)
42% (P<0.001)	8%
Secondary endpoint ≥4-point improvement in: Peak Pruritus NRS (in adults^b and adolescents) (% of patients)
37% (P<0.001)	5%

CLINICALLY MEANINGFUL IMPROVEMENT WAS SEEN AT WEEK 16 IN CONCOMITANT TCS TRIALS^1,6-8,c,d

Primary endpoint

IGA 0 (clear) or 1 (almost clear), and in adults ≥2-point improvement (% of patients)^a

Secondary endpoints

EASI-75: ≥75% improvement in lesion extent and severity
(% of patients)

≥4-point improvement in: Peak Pruritus NRS (in adults^b and children) or Worst Scratch/Itch NRS (in infants to preschoolers) (% of patients)

ADULTS
18+ years of age

CHILDREN
6-11 years of age

INFANTS TO PRESCHOOLERS
6 months to 5 years of age

CHRONOS^e

AD-1652

AD-1539^h

<30 kg: 300 mg Q4W^f

≥30 kg: 200 mg Q2W^g

DUPIXENT
+ TCS
(n=106)

Placebo
+ TCS
(n=315)

DUPIXENT
+ TCS
(n=61)

Placebo
+ TCS
(n=61)

DUPIXENT
+ TCS
(n=59)

Placebo
+ TCS
(n=62)

DUPIXENT
+ TCS
(n=83)

Placebo
+ TCS
(n=79)

39%
(P<0.0001)

12%

30%

13%

39%

10%

28%
(P<0.0001)

69%
(P<0.0001)

23%

75%

28%

75%

26%

53%
(P<0.0001)

11%

59%
(P<0.0001)

20%

54%

12%

61%

13%

48%
(P<0.0001)

ADULTS 18+ years of age
CHRONOS^e
DUPIXENT + TCS (n=106)	Placebo + TCS (n=315)
Primary endpoint IGA 0 (clear) or 1 (almost clear), and in adults ≥2-point improvement (% of patients)^a
39% (P<0.0001)	12%
Secondary endpoint EASI-75: ≥75% improvement in lesion extent and severity (% of patients)
69% (P<0.0001)	23%
Secondary endpoint ≥4-point improvement in: Peak Pruritus NRS (in adults^b and children) or Worst Scratch/Itch NRS (in infants to preschoolers) (% of patients)
59% (P<0.0001)	20%

CHILDREN 6-11 years of age
AD-1652
<30 kg: 300 mg Q4W^f
DUPIXENT + TCS (n=61)	Placebo + TCS (n=61)
≥30 kg: 200 mg Q2W^g
DUPIXENT + TCS (n=59)	Placebo + TCS (n=62)
Primary endpoint IGA 0 (clear) or 1 (almost clear), and in adults ≥2-point improvement (% of patients)^a
<30 kg: 300 mg Q4W^f
DUPIXENT 30%	Placebo 13%
≥30 kg: 200 mg Q2W^g
DUPIXENT 39%	Placebo 10%
Secondary endpoint EASI-75: ≥75% improvement in lesion extent and severity (% of patients)
<30 kg: 300 mg Q4W^f
DUPIXENT 75%	Placebo 28%
≥30 kg: 200 mg Q2W^g
DUPIXENT 75%	Placebo 26%
Secondary endpoint ≥4-point improvement in: Peak Pruritus NRS (in adults^b and children) or Worst Scratch/Itch NRS (in infants to preschoolers) (% of patients)
<30 kg: 300 mg Q4W^f
DUPIXENT 54%	Placebo 12%
≥30 kg: 200 mg Q2W^g
DUPIXENT 61%	Placebo 13%

INFANTS TO PRESCHOOLERS 6 months to 5 years of age
AD-1539^h
DUPIXENT + TCS (n=83)	Placebo + TCS (n=79)
Primary endpoint IGA 0 (clear) or 1 (almost clear), and in adults ≥2-point improvement (% of patients)^a
DUPIXENT 28% (P<0.0001)	Placebo 4%
Secondary endpoint EASI-75: ≥75% improvement in lesion extent and severity (% of patients)
DUPIXENT 53% (P<0.0001)	Placebo 11%
Secondary endpoint ≥4-point improvement in: Peak Pruritus NRS (in adults^b and children) or Worst Scratch/Itch NRS (in infants to preschoolers) (% of patients)
DUPIXENT 48% (P<0.0001)	Placebo 9%

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 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

Study designs

Studied in 7 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)

Hand and foot Peak Pruritus NRS (adults and adolescents)

Skin clearance

IGA

IGA hand and foot (adults and adolescents)

Improvement in lesion
extent
and severity

EASI-75

HECSI-75 (adults and adolescents)

Real-world results

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

VIEW RESULTS IN ADULTS

Dosage and administration

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EFFICACY AND SAFETY OVERVIEW

First and only biologic approved to treat uncontrolled moderate‑to‑severe atopic dermatitis from infancy to adulthood1

ATOPIC DERMATITIS PATIENTS AGED 12+ YEARS WITH UNCONTROLLED MODERATE-TO-SEVERE HAND AND/OR FOOT INVOLVEMENT CLINICAL TRIAL1,2

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

Demonstrated long-term safety profile

Study designs

Itch relief

Skin clearance

Improvement in lesion extent and severity

Real-world results

Dosage and administration

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First and only biologic approved to treat uncontrolled
moderate‑to‑severe atopic dermatitis from infancy to adulthood¹

ATOPIC DERMATITIS
PATIENTS AGED 12+ YEARS WITH UNCONTROLLED MODERATE-TO-SEVERE
HAND AND/OR FOOT INVOLVEMENT CLINICAL TRIAL^1,2

IMPROVEMENT WAS SEEN AT WEEK 16 IN MONOTHERAPY TRIALS^1,3-5,c,d

CLINICALLY MEANINGFUL IMPROVEMENT WAS SEEN AT WEEK 16 IN CONCOMITANT TCS TRIALS^1,6-8,c,d

Improvement in lesion
extent
and severity