Extensive lesion severity:
out of 72
mean EASI score
Intense pruritus:
out of 10
mean peak severity
Quality of life affected:
out of 30
CDLQI score
total patients on placebo (n=85) and
of total patients on DUPIXENT Q2W (n=82) received prior systemic treatments for AD
16-week, randomised, double-blind, placebo-controlled, multi-centre, parallel-group, Phase 3 trial including adolescent patients who had moderate-to-severe AD, and were not adequately controlled by topical treatment
| STUDY | STUDY DURATION (WEEKS) | NUMBER OF PATIENTS | TREATMENT ARMS | PRIMARY ENDPOINTS |
|---|---|---|---|---|
| AD-1526 | 16 | 251* | Patients were randomised (1:1:1) to 16 weeks of treatment with a) 200 mg (weight, <60 kg) or 300 mg (weight, ≥60 kg) DUPIXENT Q2W (n=82) (licensed dose)†, b) 300 mg DUPIXENT Q4W (n=84) or c) placebo Q2W (n=85). One patient in the DUPIXENT Q4W group was randomised but did not receive treatment. |
The proportion of patients with both 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 12 to 17 years old with moderate-to-severe AD inadequately controlled by topical therapies. Inclusion criteria was defined by IGA score ≥3, and EASI score ≥16, pruritus NRS ≥4, and a minimum BSA involvement of ≥10.
†Topical therapy and other systemic atopic dermatitis therapies were prohibited but allowed as rescue treatment for intolerable symptoms. The use of rescue treatment resulted in patient being classed as a non-responder.
AD, atopic dermatitis; BSA, body surface area; CDLQI, Children’s Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; TCS, topical corticosteroids.
References
