Extensive lesion severity:
out of 72
median EASI score
Intense pruritus:
out of 10
median peak severity
Quality of life affected:
out of 30
CDLQI score
total patients on placebo (n=120) and
of total patients on DUPIXENT 300 mg Q4W (n=120) received prior systemic treatments for AD
16-week, randomised, placebo-controlled, double-blind, parallel-group, Phase 3 trial including patients aged 6–11 years old with severe AD, and were not adequately controlled by topical treatment
| STUDY | STUDY DURATION (WEEKS) | NUMBER OF PATIENTS | TREATMENT ARMS | PRIMARY ENDPOINTS |
|---|---|---|---|---|
| AD-1652 |
16 |
367* |
Patients were randomised (1:1:1), to 16 weeks of treatment with a) 300 mg DUPIXENT Q4W + TCS (n=122) (licenced dose)†, b) 100 mg (weight, <30 kg) or 200 mg (weight, ≥ 30 kg) DUPIXENT Q2W + TCS (n=122) or c) placebo + TCS (n=123). |
The proportion of patients with IGA 0/1 (clear/almost clear) and the proportion of patients achieving 75% improvement in EASI (EASI-75) from baseline to Week 16. |
| *Patients were 6–11 years old with severe AD inadequately controlled by topical therapies. Inclusion criteria was defined by IGA score 4, EASI score ≥21, pruritus NRS ≥4 and a minimum BSA involvement ≥15%. †600 mg loading dose for >60 kg. ‡Rescue treatment with high-potency TCS or systemic therapy was permitted for patients with IGA=4 and/or intolerable symptoms during the treatment period. Very-high-potency TCS were prohibited, even as rescue. The use of rescue treatment resulted in patient being classed as a non-responder. |
||||
AD, atopic dermatitis; BSA, body surface area; CDLQI, Children Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, Numerical Rating Scale; Q2W, once very two weeks; Q4W, once every four weeks; TCS, topical corticosteroids.
References
