Infants to Preschoolers IGA Efficacy Results

In the treatment of infants to preschoolers (6 months to 5 years of age) with uncontrolled moderate-to-severe atopic dermatitis

Clearer skin with DUPIXENT + TCS

Clearer skin in AD-1539

AD-1539 6 MONTHS TO
5 YEARS OF AGE

IGA 0 OR 1 AT WEEK 16
(primary endpoint)^1,2,a,b

Improvement after first
dose, at Week 4 (12% vs 1%)

Proportion of
patients with IGA 0
or 1 from baseline
to Week 16

60
50
40
30
20
10
0

Weeks

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16

28%

≈7x as many
patients
(P<0.001)

4%

DUPIXENT 200/300 mg Q4W + TCS (n=83) Placebo + TCS (n=79)

Definitive conclusions cannot be made for time points earlier than Week 16 as those data were not multiplicity controlled and P value was nominal.

Q4W, once every 4 weeks; TCS, topical corticosteroids.

^aFull Analysis Set includes all subjects randomized.¹

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

Visible results with DUPIXENT

In DUPIXENT clinical trials including infants to preschoolers, the primary endpoint was the proportion of subjects with an Investigator's Global Assessment (IGA) of 0 (clear) or 1 (almost clear) at Week 16.¹

Actual patients in a phase 3 DUPIXENT trial (AD-1539) in infants to preschoolers (aged 6 months to 5 years). Patients were prescribed concomitant low-potency TCS based on the clinical trial program. Patients 1, 2, and 3 were considered clinical responders. Individual results may vary.^1,2

Patient 1: 4-year-old achieved a 2-point improvement in IGA

BASELINE: IGA 3 (moderate)

DRAG TO SEE
RESULTS

WEEK 16: IGA 1
(almost clear)

Patient 2: 4-year-old achieved a 3-point improvement in IGA

BASELINE: IGA 4 (severe)

DRAG TO SEE
RESULTS

WEEK 16: IGA 1 (almost clear)

Patient 3: 3-year-old achieved a 2-point improvement in IGA

BASELINE: IGA 3 (moderate)

DRAG TO SEE
RESULTS

WEEK 16: IGA 1 (almost clear)

Patient 4: 2-year-old achieved a 2-point improvement in IGA

BASELINE: IGA 4 (severe)

DRAG TO SEE
RESULTS

WEEK 16: IGA 2
(mild)

Explore more IGA
efficacy results

VIEW ADULT DATA VIEW ADOLESCENT (12 TO 17 YEARS) DATA VIEW CHILD (6 TO 11 YEARS) DATA

How is clear or almost-clear skin (IGA) assessed?

IGA assessed the overall severity of the clinical signs of atopic dermatitis²

A 0- to 4-point scoring system of the overall severity of atopic dermatitis skin lesions²

4

Severe
Disease

Severe erythema and severe
papulation/infiltration

3

Moderate
Disease

Moderate erythema and moderate
papulation/infiltration

2

Mild
Disease

Mild erythema and mild
papulation/infiltration

1

Almost
Clear

Just perceptible erythema, and
just perceptible papulation/infiltration

0

Clear

No inflammatory signs of atopic dermatitis

Example representation of IGA scoring. Not an actual patient.

A clinical responder
was defined as a
patient achieving IGA 0
or 1 and at least a
2-point improvement
from baseline¹

IGA, Investigator's Global Assessment.
Example representation of IGA scoring.
Not an actual patient.

READY TO PRESCRIBE DUPIXENT?

DOSAGE AND ADMINISTRATION