Studied in over 3000 patients across 7 pivotal trials

Proven itch relief and skin clearance at week 52 in adults (CHRONOS)^1,2

≈4x EXPERIENCED
ITCH RELIEF

Proportion with ≥4-point reduction in
Peak Pruritus NRS: 51% with
DUPIXENT + TCS vs 13% with placebo +
TCS; P<0.0001, secondary endpoint

≈3x ACHIEVED ≥75%
SKIN CLEARANCE

Proportion achieving EASI-75: 65% with
DUPIXENT + TCS vs 22% with placebo +
TCS; P<0.0001, secondary endpoint

Clinically meaningful improvement was seen at Week 16 in concomitant
TCS trials^1‑4,a,b

Primary endpoint

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

Secondary endpoints

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

≥4-point improvement in: Peak Pruritus NRS (in adults^h 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^c

AD-1652

AD-1539^f

<30 kg: 300 mg Q4W^d

≥30 kg: 200 mg Q2W^e

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^c
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)^g
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^h 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^d
DUPIXENT + TCS (n=61)	Placebo + TCS (n=61)
≥30 kg: 200 mg Q2W^e
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)^g
<30 kg: 300 mg Q4W^d
DUPIXENT 30%	Placebo 13%
≥30 kg: 200 mg Q2W^e
DUPIXENT 39%	Placebo 10%
Secondary endpoint EASI-75: ≥75% improvement in lesion extent and severity (% of patients)
<30 kg: 300 mg Q4W^d
DUPIXENT 75%	Placebo 28%
≥30 kg: 200 mg Q2W^e
DUPIXENT 75%	Placebo 26%
Secondary endpoint ≥4-point improvement in: Peak Pruritus NRS (in adults^h and children) or Worst Scratch/Itch NRS (in infants to preschoolers) (% of patients)
<30 kg: 300 mg Q4W^d
DUPIXENT 54%	Placebo 12%
≥30 kg: 200 mg Q2W^e
DUPIXENT 61%	Placebo 13%

INFANTS TO PRESCHOOLERS 6 months to 5 years of age
AD-1539^f
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)^g
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^h and children) or Worst Scratch/Itch NRS (in infants to preschoolers) (% of patients)
DUPIXENT 48% (P<0.0001)	Placebo 9%

Improvement was seen at Week 16 in monotherapy trials^1,5,6,a,b

Primary endpoint

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

Secondary endpoints

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

≥4-point improvement in: Peak Pruritus NRS (in adults^h 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)^g

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)^g

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)

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)^g
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^h 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)^g
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^h and adolescents) (% of patients)
37% (P<0.001)	5%

Atopic dermatitis patients aged 12+ years with uncontrolled moderate-to-
severe hand and/or foot involvement clinical trial^1,7

Primary endpoint

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

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^h 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)^g

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^h 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)^g
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^h and adolescents) (% of patients)
52% (P<0.0001)	14%

The results presented are not intended to be comparative across clinical 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 scales were defined as 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.⁸

^h 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

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%) were 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 REDUCTION

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)

DATA FROM 3 REAL‑WORLD STUDIES

VIEW REAL‑WORLD RESULTS

Efficacy and Safety Overview

ITCH RELIEF AND SKIN CLEARANCE DEMONSTRATED ACROSS
AGE GROUPS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Studied in over 3000 patients across 7 pivotal trials

Proven itch relief and skin clearance at week 52 in adults (CHRONOS)^1,2

Clinically meaningful improvement was seen at Week 16 in concomitant
TCS trials^1‑4,a,b

Improvement was seen at Week 16 in monotherapy trials^1,5,6,a,b

Atopic dermatitis patients aged 12+ years with uncontrolled moderate-to-
severe hand and/or foot involvement clinical trial^1,7

Demonstrated long-term safety profile

Study designs

Itch REDUCTION

Skin clearance

Improvement in lesion
extent
and severity

DATA FROM 3 REAL‑WORLD STUDIES

Efficacy and Safety Overview

ITCH RELIEF AND SKIN CLEARANCE DEMONSTRATED ACROSS AGE GROUPS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Studied in over 3000 patients across 7 pivotal trials

Proven itch relief and skin clearance at week 52 in adults (CHRONOS)1,2

Clinically meaningful improvement was seen at Week 16 in concomitant TCS trials1‑4,a,b

Improvement was seen at Week 16 in monotherapy trials1,5,6,a,b

Atopic dermatitis patients aged 12+ years with uncontrolled moderate-to-severe hand and/or foot involvement clinical trial1,7

Demonstrated long-term safety profile

Study designs

Itch REDUCTION

Skin clearance

Improvement in lesion extent and severity

DATA FROM 3 REAL‑WORLD STUDIES

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ITCH RELIEF AND SKIN CLEARANCE DEMONSTRATED ACROSS
AGE GROUPS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Proven itch relief and skin clearance at week 52 in adults (CHRONOS)^1,2

Clinically meaningful improvement was seen at Week 16 in concomitant
TCS trials^1‑4,a,b

Improvement was seen at Week 16 in monotherapy trials^1,5,6,a,b

Atopic dermatitis patients aged 12+ years with uncontrolled moderate-to-
severe hand and/or foot involvement clinical trial^1,7

Improvement in lesion
extent
and severity