|
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 |
>2,200 |
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 |
>2,200 |
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 |
ATOPIC DERMATITIS
PATIENTS AGED 12+ YEARS WITH UNCONTROLLED MODERATE-TO-SEVERE
HAND AND/OR FOOT INVOLVEMENT1,2
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
adultsb and
adolescents) (% of
patients)
ADULTS AND ADOLESCENTS
12+ years of
age
AD-HAFT MONOTHERAPY
ADULTS
18+ years of age
DUPIXENT monotherapy
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 adultsh and adolescents)
(% of patients)
ADOLESCENTS
12-17 years of age
DUPIXENT monotherapy
AD-1526
DUPIXENT (n=67)
Placebo (n=66)
Primary
endpoint
≥4-point improvement
in hand and foot Peak
Pruritus NRS (in
adultsb 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 adultsh and adolescents)
(% of patients)
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<0.0028) |
22% |
≥4-point improvement in hand and foot
Peak Pruritus NRS (in adultsb and adolescents) (% of patients) |
52%
(P<0.0001) |
14% |
IMPROVEMENT WAS SEEN AT WEEK 16 IN MONOTHERAPY TRIALS1,3,4,c,d
Primary endpoint
IGA 0 (clear) or 1 (almost clear), and in adultsb 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
adultsb and adolescents) (% of patients)
DUPIXENT monotherapy
ADULTS
18+ years of age
ADOLESCENTS
12-17 years of age
ADULTS
18+ years of age
DUPIXENT monotherapy
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 adultsh 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)
9%
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 adultsh and adolescents)
(% of patients)
51%
(P<0.001)
15%
44%
(P<0.001)
12%
41%
(P<0.001)
12%
36%
(P<0.001)
10%
DUPIXENT monotherapy
|
ADULTS
18+ years of age
|
SOLO 1 |
SOLO 2 |
DUPIXENT
(n=224) |
PLACEBO
(n=224) |
DUPIXENT
(n=223) |
PLACEBO
(n=236) |
Primary
endpoint
IGA 0 (clear) or 1 (almost clear), and in adultsb 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 adultsb 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 adultsh and adolescents) (% of patients)
|
37%
(P<0.001) |
5% |
CLINICALLY MEANINGFUL IMPROVEMENT WAS SEEN AT WEEK 16 IN CONCOMITANT TCS
TRIALS1,5‑7,c,d
Primary endpoint
IGA 0 (clear) or 1 (almost clear), and in adults ≥2-point
improvement (% of patients)
Secondary endpoints
EASI-75: ≥75% improvement in lesion extent and
severity
(% of patients)
≥4-point improvement in: Peak Pruritus NRS (in
adultsb 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
CHRONOSe
AD-1652
AD-1539h
<30 kg: 300 mg
Q4Wf
≥30 kg: 200 mg
Q2Wg
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)
ADULTS
18+ years of age
|
CHRONOSe |
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)d
|
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 adultsb 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 Q4Wf |
DUPIXENT + TCS
(n=61) |
Placebo + TCS
(n=61) |
≥30 kg: 200 mg Q2Wg |
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)f
|
<30 kg: 300 mg Q4Wf |
DUPIXENT
30% |
Placebo
13% |
≥30 kg: 200 mg Q2Wg |
DUPIXENT
39% |
Placebo
10% |
Secondary
endpoint
EASI-75: ≥75% improvement in lesion extent and severity (% of patients) |
<30 kg: 300 mg Q4Wf |
DUPIXENT
75% |
Placebo
28% |
≥30 kg: 200 mg Q2Wg |
DUPIXENT
75% |
Placebo
26% |
Secondary
endpoint
≥4-point improvement in: Peak Pruritus NRS (in adultsg and children) or Worst Scratch/Itch
NRS (in infants to preschoolers) (% of patients) |
<30 kg: 300 mg Q4Wf |
DUPIXENT
54% |
Placebo
12% |
≥30 kg: 200 mg Q2Wg |
DUPIXENT
61% |
Placebo
13% |
INFANTS TO
PRESCHOOLERS 6 months to 5 years of age |
AD-1539h |
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)
|
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 adultsh 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.1
b Data analyses reflect patients with baseline Peak Pruritus NRS 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).3,6
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