| AD-HAFT (Adults and adolescents aged 12+ years) |
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| Trial Overview1,2 | Number of patients | 133a | |
| Design | Randomized, double-blind | ||
| Duration | 16 weeks | ||
| Treatment arms | DUPIXENT monotherapy vs placebob | ||
| Dosing | For adolescents <60 kg Initial loading dose: 400 mg (2 x 200 mg SC) Followed by: 200 mg Q2W (1 x 200 mg SC) |
For adults and adolescents ≥60 kg Initial loading dose: 600 mg (2 x 300 mg SC) Followed by: 300 mg Q2W (1 x 300 mg SC) |
|
| Primary endpoint | IGA hand or foot 0 (clear) or 1 (almost clear) at Week 16 | ||
| Secondary endpoints | ≥4-point reduction in hand and/or foot Peak Pruritus NRS at Week 16 ≥75% improvement in hand lesion extent and severity (HECSI-75) at Week 16 |
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| Baseline Disease Severity1,3 | IGA hand and foot 3 (moderate disease) |
72% | |
| IGA hand and foot 4 (severe disease) |
28% | ||
| Mean HECSI (0 to 360) |
46.8 | ||
| Hand and foot Peak Pruritus NRS (out of 10)c |
7.1 | ||
| AD-HAFT (Adults and adolescents aged 12+ years) |
|
| Trial Overview1,2 | |
| Number of patients | 133a |
| Design | Randomized, double-blind |
| Duration | 16 weeks |
| Treatment arms | DUPIXENT monotherapy vs placebob |
| Dosing | For adolescents <60 kg Initial loading dose: 400 mg (2 x 200 mg SC) Followed by: 200 mg Q2W (1 x 200 mg SC) For adults and adolescents ≥60 kg Initial loading dose: 600 mg (2 x 300 mg SC) Followed by: 300 mg Q2W (1 x 300 mg SC) |
| Primary endpoint | IGA hand or foot 0 (clear) or 1 (almost clear) at Week 16 |
| Secondary endpoints | ≥4-point reduction in hand and/or foot Peak Pruritus NRS at Week 16 ≥75% improvement in hand lesion extent and severity (HECSI-75) at Week 16 |
| Baseline Disease Severity1,3 | |
| IGA hand and foot 3 (moderate disease) |
72% |
| IGA hand and foot 4 (severe disease) |
28% |
| Mean HECSI (0 to 360) |
46.8 |
| Hand and foot Peak Pruritus NRS (out of 10)c |
7.1 |
aParticipants included subjects with both hand and foot involvement (n=71), foot-only involvement (n=4), and hand-only involvement (n=58).1
bPatients were not allowed to use TCS on the hands and feet but could use TCS on other parts of the body with certain restrictions.1
cWeekly average of hand and foot Peak Pruritus NRS score (10 indicates the most severe).1
Watch healthcare providers discuss AD and treatment with DUPIXENT
AD, atopic dermatitis; HECSI, Hand Eczema Severity Index; IGA, Investigator's Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; SC, subcutaneous; TCS, topical corticosteroids.