| INFANTS TO PRESCHOOLERS AD-1539 (6 months to 5 years)1,2 |
CHILDREN AD-1652 (6-11 years)1,3 |
ADOLESCENTS AD-1526 (12-17 years)4 |
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| Trial Overview | Number of patients | 162 | 367 | 251 |
| Design | Randomized, phase 3, double-blind | |||
| Duration | 16 weeks | |||
| Treatment arms | DUPIXENT + TCS vs placebo + TCS | DUPIXENT monotherapy vs placebo |
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| Primary endpoint | IGA 0 (clear) or 1 (almost clear), and in adolescents ≥2-point improvement at Week 16 | |||
| Secondary endpoints | ≥75% improvement in lesion extent and severity (EASI-75) at Week 16 | |||
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INFANTS TO PRESCHOOLERS AD-1539 (6 months to 5 years)1,2 |
CHILDREN AD-1652 (6-11 years)1,3 |
ADOLESCENTS AD-1526 (12-17 years)4 |
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| Weight-Tiered Dosing | Weight | 5 kg to <15 kg | 15 to <30 kg | 15 to <30 kg | 30 to <60 kg | 30 to <60 kg | ≥60 kg |
| Dosing | No initial loading dose recommended |
Initial loading dose: 600 mg (2 x 300 mg SC) |
Initial loading dose: 400 mg (2 x 200 mg SC) |
Initial loading dose: 400 mg (2 x 200 mg SC) |
Initial loading dose: 600 mg (2 x 300 mg SC) |
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|
200 mg Q4W (1 x 200 mg SC) |
300 mg Q4W (1 x 300 mg SC) |
Followed by: 300 mg Q4W (1 x 300 mg SC) |
Followed by: 200 mg Q2W (1 x 200 mg SC) |
Followed by: 200 mg Q2W (1 x 200 mg SC) |
Followed by: 300 mg Q2W (1 x 300 mg SC) |
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| INFANTS TO PRESCHOOLERS AD-1539 (6 months to 5 years)1,2 |
CHILDREN AD-1652 (6-11 years)1,3 |
ADOLESCENTS AD-1526 (12-17 years)4 |
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| Baseline Disease Severity |
Mean age | 3.8 years | 8.5 years | 14.5 years |
| Mean disease duration | 3.4 years | ≈7 years | ≈12 years | |
| IGA 3a (moderate disease) |
23% | 0 | 46% | |
| IGA 4a (severe disease) |
77% | 100% | 54% | |
| Mean EASI score (out of 72)b |
34.1 | 37.9 | 36.0 | |
| Mean BSAc | 58% | 58% | 57% | |
| Mean Worst Scratch/Itch in infants to preschoolers OR Peak Pruritus NRS (out of 10) in children and adolescentsd |
7.6 | 7.8 | 8.0 | |
| INFANTS TO PRESCHOOLERS AD-1539 (6 months to 5 years)1,2 |
|
| Trial Overview | |
| Number of patients | 162 |
| Design | Randomized, phase 3, double-blind |
| Duration | 16 weeks |
| Treatment arms | DUPIXENT + TCS vs placebo + TCS |
| Primary endpoint | IGA 0 (clear) or 1 (almost clear) at Week 16 |
| Secondary endpoints | ≥75% improvement in lesion extent and severity (EASI-75) at Week 16 |
| ≥4-point reduction in Worst Scratch/Itch NRS at Week 16 |
|
| Weight-Tiered Dosing | |
| 5 kg to <15 kg | No initial loading dose recommended 200 mg Q4W (1 x 200 mg SC) |
| 15 to <30 kg | No initial loading dose recommended 300 mg Q4W (1 x 300 mg SC) |
| Baseline Disease Severity | |
| Mean age | 3.8 years |
| Mean disease duration | 3.4 years |
| IGA 3a (moderate disease) |
23% |
| IGA 4a (severe disease) |
77% |
| Mean EASI score (out of 72)b |
34.1 |
| Mean BSAc | 58% |
| Mean Worst Scratch/Itch NRS (out of 10)d | 7.6 |
| CHILDREN AD-1652 (6-11 years)1,3 |
|
| Trial Overview | |
| Number of patients | 367 |
| Design | Randomized, phase 3, double-blind |
| Duration | 16 weeks |
| Treatment arms | DUPIXENT + TCS vs placebo + TCS |
| Primary endpoint | IGA 0 (clear) or 1 (almost clear) at Week 16 |
| Secondary endpoints | ≥75% improvement in lesion extent and severity (EASI-75) at Week 16 |
| ≥4-point reduction in Peak Pruritus NRS at Week 16 |
|
| Weight-Tiered Dosing | |
| 15 to <30 kg | Initial loading dose: 600 mg (2 x 300 mg SC) Followed by: 300 mg Q4W (1 x 300 mg SC) |
| 30 to <60 kg | Initial loading dose: 400 mg (2 x 200 mg SC) Followed by: 200 mg Q2W (1 x 200 mg SC) |
| Baseline Disease Severity | |
| Mean age | 8.5 years |
| Mean disease duration | ≈7 years |
| IGA 3a (moderate disease) |
0 |
| IGA 4a (severe disease) |
100% |
| Mean EASI score (out of 72)b |
37.9 |
| Mean BSAc | 58% |
| Mean Peak Pruritus NRS (out of 10)d | 7.8 |
| ADOLESCENTS AD-1526 (12-17 years)4 |
|
| Trial Overview | |
| Number of patients | 251 |
| Design | Randomized, phase 3, double-blind |
| Duration | 16 weeks |
| Treatment arms | DUPIXENT monotherapy vs placebo |
| Primary endpoint | IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 |
| Secondary endpoints | ≥75% improvement in lesion extent and severity (EASI-75) at Week 16 |
| ≥4-point reduction in Peak Pruritus NRS at Week 16 |
|
| Weight-Tiered Dosing | |
| 30 to <60 kg | Initial loading dose: 400 mg (2 x 200 mg SC) Followed by: 200 mg Q2W (1 x 200 mg SC) |
| ≥60 kg | Initial loading dose: 600 mg (2 x 300 mg SC) Followed by: 300 mg Q2W (1 x 300 mg SC) |
| Baseline Disease Severity | |
| Mean age | 14.5 years |
| Mean disease duration | ≈12 years |
| IGA 3a (moderate disease) |
46% |
| IGA 4a (severe disease) |
54% |
| Mean EASI score (out of 72)b |
36.0 |
| Mean BSAc | 57% |
| Mean Peak Pruritus NRS (out of 10)d | 8.0 |
aIGA scale was defined as 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. Disease-severity was defined by: Infants to preschoolers with IGA score ≥3, children with IGA score =4, and adolescents with IGA score ≥3.1
bDisease severity was defined by: infants to preschoolers with an EASI score ≥16, children with an EASI score ≥21, and adolescents with an EASI score ≥16.1
cDisease severity was defined by: infants to preschoolers with BSA involvement of ≥10%, children with BSA involvement ≥15%, and adolescents with BSA involvement of ≥10%.1
dWeekly average of Worst Scratch/Itch NRS and Peak Pruritus NRS score (10 indicates the most severe).1
Watch healthcare providers discuss AD and treatment with DUPIXENT
AD, atopic dermatitis; BSA, body surface area; 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; SC, subcutaneous; TCS, topical corticosteroids.