Proven long-term itch relief and skin clearance at Week 52 in adults (CHRONOS)1,2
≈4x
EXPERIENCED ITCH RELIEF
Proportion of patients with ≥4-point reduction in Peak Pruritus NRS: 51% with DUPIXENT + TCS vs 13% with placebo + TCS; P<0.0001, secondary endpoint1,2
≈3x
ACHIEVED ≥75% SKIN IMPROVEMENT
Proportion of patients achieving EASI-75: 65% with DUPIXENT + TCS vs 22% with placebo + TCS; P<0.0001, secondary endpoint1,2
Significant improvement at Week 16 in 3 pivotal trials in adults 1-3,a-d
| CHRONOS (concomitant TCS)e |
SOLO 1 (monotherapy) |
SOLO 2 (monotherapy) |
||||
| DUPIXENT + TCS (n=106) % of patients |
Placebo + TCS (n=315) % of patients |
DUPIXENT (n=224) % of patients |
Placebo (n=224) % of patients |
DUPIXENT (n=233) % of patients |
Placebo (n=236) % of patients |
|
| SKIN CLEARANCE Primary endpoint: IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement from baseline |
39% (P<0.0001) |
12% | 38% (P<0.001) |
10% | 36% (P<0.001) |
9% |
| Secondary endpoint: EASI-75 (≥75% improvement in lesion extent and severity) | 69% (P<0.0001) |
23% | 51% (P<0.001) |
15% | 44% (P<0.001) |
12% |
| ITCH RELIEF Secondary endpoint: ≥4-point reduction in Peak Pruritus NRS from baseline |
59%f (P<0.0001) |
20% | 41%g (P<0.001) |
12% | 36%g (P<0.001) |
10% |
| CHRONOS (concomitant TCS)e |
|
| SKIN CLEARANCE Primary endpoint: IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement from baseline |
|
| DUPIXENT + TCS (n=106) % of patients |
39% (P<0.0001) |
| Placebo + TCS (n=315) % of patients |
12% |
| Secondary endpoint: EASI-75 (≥75% improvement in lesion extent and severity) | |
| DUPIXENT + TCS (n=106) % of patients |
69% (P<0.0001) |
| Placebo + TCS (n=315) % of patients |
23% |
| ITCH RELIEF Secondary endpoint: ≥4-point reduction in Peak Pruritus NRS from baseline |
|
| DUPIXENT + TCS (n=106) % of patients |
59%f (P<0.0001) |
| Placebo + TCS (n=315) % of patients |
20% |
| SOLO 1 (monotherapy) |
|
| SKIN CLEARANCE Primary endpoint: IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement from baseline |
|
| DUPIXENT (n=224) % of patients |
38% (P<0.001) |
| Placebo (n=224) % of patients |
10% |
| Secondary endpoint: EASI-75 (≥75% improvement in lesion extent and severity) | |
| DUPIXENT (n=224) % of patients |
51% (P<0.001) |
| Placebo (n=224) % of patients |
15% |
| ITCH RELIEF Secondary endpoint: ≥4-point reduction in Peak Pruritus NRS from baseline |
|
| DUPIXENT (n=224) % of patients |
41%g (P<0.001) |
| Placebo (n=224) % of patients |
12% |
| SOLO 2 (monotherapy) |
|
| SKIN CLEARANCE Primary endpoint: IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement from baseline |
|
| DUPIXENT (n=233) % of patients |
36% (P<0.001) |
| Placebo (n=236) % of patients |
9% |
| Secondary endpoint: EASI-75 (≥75% improvement in lesion extent and severity) | |
| DUPIXENT (n=233) % of patients |
44% (P<0.001) |
| Placebo (n=236) % of patients |
12% |
| ITCH RELIEF Secondary endpoint: ≥4-point reduction in Peak Pruritus NRS from baseline |
|
| DUPIXENT (n=233) % of patients |
36%g (P<0.001) |
| Placebo (n=236) % of patients |
10% |
aCHRONOS, SOLO 1, and SOLO 2 enrolled adult subjects. In these trials, disease severity at baseline was defined by an IGA score of ≥3 in the overall assessment of AD lesions on a severity scale of 0 (clear) to 4 (severe); an EASI score of ≥16 on a scale of 0 to 72; and a minimum BSA involvement of ≥10%. At baseline, 52% of subjects had an IGA score of 3 (moderate); 48% had an IGA of 4 (severe); mean EASI score was 33; weekly averaged Peak Pruritus NRS was 7 on a scale of 0 to 10. Mean disease duration was ≈28 years and mean age was 38 years.1,4
bIn CHRONOS, SOLO 1, and SOLO 2, a loading dose of 600 mg (2 x 300 mg SC injections) was followed by 300 mg (1 SC injection) Q2W.1
cFull analysis set includes all subjects randomized.1
dIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.1
eIn CHRONOS, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.1
fData analyses reflect patients with baseline Peak Pruritus NRS score ≥4 in the DUPIXENT + TCS (n=102) group and placebo + TCS (n=299) group.1
gData analyses reflect patients with baseline Peak Pruritus NRS score ≥4. In SOLO 1, DUPIXENT (n=213) and placebo (n=212). In SOLO 2, DUPIXENT (n=225) and placebo (n=221).1
Clinically meaningful itch relief and skin clearance at Week 16 in 3 pivotal trials in pediatric patients1,5-7,a-d
| INFANTS TO PRESCHOOLERS (6 months to 5 years) AD-1539 |
CHILDREN (6-11 years) AD-1652 |
ADOLESCENTS (12-17 years) AD-1526 |
||||||
| 200/300 mg Q4W | <30 kg: 300 mg Q4W | ≥30 kg: 200 mg Q2W | 200/300 mg Q2W | |||||
| DUPIXENT + TCS (n=83) % of patients |
Placebo + TCS (n=79) % of patients |
DUPIXENT + TCS (n=61) % of patients |
Placebo + TCS (n=61) % of patients |
DUPIXENT + TCS (n=59) % of patients |
Placebo + TCS (n=62) % of patients |
DUPIXENT (n=82) % of patients |
Placebo (n=85) % of patients |
|
| SKIN CLEARANCE Primary endpoint: IGA 0 (clear) or 1 (almost clear), and in adolescents ≥2-point improvement from baseline |
28% (P<0.0001) |
4% | 30% | 13% | 39% | 10% | 24% (P<0.001) |
2% |
| Secondary endpoint: EASI-75 (≥75% improvement in lesion extent and severity) | 53% (P<0.0001) |
11% | 75% | 28% | 75% | 26% | 42% (P<0.001) |
8% |
| ITCH RELIEF Secondary endpoints: ≥4-point reduction from baseline in Peak Pruritus NRS (children and adolescents) and in Worst Scratch/Itch NRS (infants to preschoolers) |
48% (P<0.0001) |
9% | 54% | 12% | 61% | 13% | 37% (P<0.001) |
5% |
| INFANTS TO PRESCHOOLERS (6 months to 5 years) AD-1539 |
|
| SKIN CLEARANCE Primary endpoint: IGA 0 (clear) or 1 (almost clear) |
|
| 200/300 mg Q4W | |
| DUPIXENT + TCS (n=83) % of patients |
28% (P<0.0001) |
| Placebo + TCS (n=79) % of patients |
4% |
| Secondary endpoint: EASI-75 (≥75% improvement in lesion extent and severity) | |
| 200/300 mg Q4W | |
| DUPIXENT + TCS (n=83) % of patients |
53% (P<0.0001) |
| Placebo + TCS (n=79) % of patients |
11% |
| ITCH RELIEF Secondary endpoint: ≥4-point reduction from baseline in Worst Scratch/Itch NRS |
|
| 200/300 mg Q4W | |
| DUPIXENT + TCS (n=83) % of patients |
48% (P<0.0001) |
| Placebo + TCS (n=79) % of patients |
9% |
| CHILDREN (6-11 years) AD-1652 |
|
| SKIN CLEARANCE Primary endpoint: IGA 0 (clear) or 1 (almost clear) |
|
| <30 kg: 300 mg Q4W | |
| DUPIXENT + TCS (n=61) % of patients |
30% |
| Placebo + TCS (n=61) % of patients |
13% |
| ≥30 kg: 200 mg Q2W | |
| DUPIXENT + TCS (n=59) % of patients |
39% |
| Placebo + TCS (n=62) % of patients |
10% |
| Secondary endpoint: EASI-75 (≥75% improvement in lesion extent and severity) | |
| <30 kg: 300 mg Q4W | |
| DUPIXENT + TCS (n=61) % of patients |
75% |
| Placebo + TCS (n=61) % of patients |
28% |
| ≥30 kg: 200 mg Q2W | |
| DUPIXENT + TCS (n=59) % of patients |
75% |
| Placebo + TCS (n=62) % of patients |
26% |
| ITCH RELIEF Secondary endpoint: ≥4-point reduction from baseline in Peak Pruritus NRS |
|
| <30 kg: 300 mg Q4W | |
| DUPIXENT + TCS (n=61) % of patients |
54% |
| Placebo + TCS (n=61) % of patients |
12% |
| ≥30 kg: 200 mg Q2W | |
| DUPIXENT + TCS (n=59) % of patients |
61% |
| Placebo + TCS (n=62) % of patients |
13% |
| ADOLESCENTS (12-17 years) AD-1526 |
|
| SKIN CLEARANCE Primary endpoint: IGA 0 (clear) or 1 (almost clear), and in adolescents ≥2-point improvement from baseline |
|
| 200/300 mg Q2W | |
| DUPIXENT (n=82) % of patients |
24% (P<0.001) |
| Placebo (n=85) % of patients |
2% |
| Secondary endpoint: EASI-75 (≥75% improvement in lesion extent and severity) | |
| 200/300 mg Q2W | |
| DUPIXENT (n=82) % of patients |
42% (P<0.001) |
| Placebo (n=85) % of patients |
8% |
| ITCH RELIEF Secondary endpoint: ≥4-point reduction from baseline in Peak Pruritus NRS |
|
| 200/300 mg Q2W | |
| DUPIXENT (n=82) % of patients |
37% (P<0.001) |
| Placebo (n=85) % of patients |
5% |
aDisease severity at baseline was defined by an IGA score of 4 in children and ≥3 in infants to preschoolers and adolescents in the overall assessment of AD lesions on a severity scale of 0 (clear) to 4 (severe); an EASI score ≥21 in children and ≥16 in infants to preschoolers and adolescents on a scale of 0 to 72; and a minimum BSA involvement of ≥15% in children and ≥10% in infants to preschoolers and adolescents. At baseline, 46% of adolescents and 23% of infants to preschoolers had an IGA score of 3 (moderate); 54% of adolescents, 100% of children, and 77% of infants to preschoolers had an IGA of 4 (severe); mean EASI score was 36 for adolescents, 38 for children, and 34.1 for infants to preschoolers; weekly average Peak Pruritus NRS was 8 on a scale of 0 to 10 for adolescents and 7.8 for children; and weekly average of daily Worst Scratch/Itch NRS was 7.6 for infants to preschoolers on a scale of 0 to 10. Mean disease duration was ≈12 years for adolescents, ≈7 years for children, and 3.4 years for infants to preschoolers. Mean age was 14.5 years for adolescents, 8.5 years for children, and 3.8 years for infants to preschoolers.1,5
bA loading dose of 600 mg (2 x 300 mg SC injections) was followed by 300 mg (1 SC injection) Q2W for pediatric subjects (6-17 years) ≥60 kg; a loading dose of 400 mg (2 x 200 mg SC injections) was followed by 200 mg (1 SC injection) Q2W for pediatric subjects 30 kg to <60 kg; and a loading dose of 600 mg (2 x 300 mg SC injections) was followed by 300 mg (1 SC injection) Q4W for pediatric subjects <30 kg. For infants to preschoolers, there is no initial loading dose, and the weight-tiered dosage regimen was 200 mg (1 SC injection) Q4W for subjects 5 to 15 kg, and 300 mg (1 SC injection) Q4W for subjects 15 kg to <30 kg.1
cFull analysis set includes all subjects randomized.1
dIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.1
Significant itch relief and skin clearance at Week 16 in patients aged 12+ years with hand and/or foot involvement1,8,a-d
| AD-HAFT (monotherapy, 12+ years) |
||
| DUPIXENT (n=67) % of patients |
Placebo (n=66) % of patients |
|
| SKIN CLEARANCE Primary endpoint: IGA hand and foot 0 (clear) or 1 (almost clear) |
40% (P=0.003) |
17% |
| Secondary endpoint: HECSI-75 (≥75% improvement in hand lesion extent and severity) | 47% (P<0.05) |
22% |
| ITCH RELIEF Secondary endpoint: ≥4-point reduction in hand and foot Peak Pruritus NRS from baseline |
52% (P<0.0001) |
14% |
| AD-HAFT (monotherapy, 12+ years) |
|
| SKIN CLEARANCE Primary endpoint: IGA hand and foot 0 (clear) or 1 (almost clear) |
|
| DUPIXENT (n=67) % of patients |
40% (P=0.003) |
| Placebo (n=66) % of patients |
17% |
| Secondary endpoint: HECSI-75 (≥75% improvement in hand lesion extent and severity) | |
| DUPIXENT (n=67) % of patients |
47% (P<0.05) |
| Placebo (n=66) % of patients |
22% |
| ITCH RELIEF Secondary endpoint: ≥4-point reduction in hand and foot Peak Pruritus NRS from baseline |
|
| DUPIXENT (n=67) % of patients |
52% (P<0.0001) |
| Placebo (n=66) % of patients |
14% |
aAD-HAFT enrolled adult and adolescent patients (12-17 years). In this trial, disease severity at baseline was defined by an IGA hand and foot score of ≥3 on a severity scale of 0 (clear) to 4 (severe). Participants included subjects with both hand and foot involvement (n=71), foot-only involvement (n=4), and hand-only involvement (n=58). At baseline, 72% of subjects had an IGA hand and foot score of 3 (moderate) and 28% had an IGA hand and foot score of 4 (severe); weekly average hand and foot Peak Pruritus NRS was 7.1 on a scale of 0 to 10; and mean HECSI score was 46.8 on a scale of 0 to 360.1,8
bFull analysis set includes all subjects randomized.1
cIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.1
dIn AD-HAFT, a loading dose of 600 mg (2 x 300 mg SC injections) was followed by 300 mg (1 SC injection) Q2W for adults and adolescents ≥60 kg; a loading dose of 400 mg (2 x 200 mg SC injections) was followed by 200 mg (1 SC injection) Q2W for adolescents <60 kg.1
The results presented are not intended to be comparative across clinical trials.
Demonstrated long-term safety profile
The Week 52 safety profile of DUPIXENT + TCS in adults was generally consistent with the Week 16 safety profile 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
AD, atopic dermatitis; BSA, body surface area; EASI, Eczema Area and Severity Index; HECSI, Hand Eczema Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; Q4W, once every 4 weeks; SC, subcutaneous; TCS, topical corticosteroids.
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