Extensive lesion severity:
out of 72
median EASI score
Intense pruritus:
out of 10
median peak severity
Large body surface area affected:
median
Quality of life strongly impacted:
out of 30
median DLQI score
52-week, randomised, double-blind, placebo-controlled, multi-centre, parallel-group, Phase 3 trial including patients who had moderate-to-severe AD for at least 3 years, and were not adequately controlled by topical treatments2
| STUDY | STUDY DURATION (WEEKS) | NUMBER OF PATIENTS | TREATMENT ARMS | PRIMARY ENDPOINTS |
|---|---|---|---|---|
| CHRONOS | 52 | 740* | Initial dose of 600 mg DUPIXENT (two 300 mg injections)/matching placebo on day 1, followed by 300 mg DUPIXENT + TCS Q2W/ 300 mg DUPIXENT + TCS QW/ matching placebo + TCS |
Proportion of patients who achieved both IGA 0/1 (clear/almost clear) and a ≥2-point reduction from baseline at Week 16 (0–4 scale) Proportion of patients who achieved EASI-75 from baseline at Week 16 |
| *Patients were ≥18 years of age with moderate-to-severe AD defined by IGA score ≥3, an EASI score ≥16, and a minimum BSA involvement of ≥10%. | ||||
16-week, randomised, double-blind, placebo-controlled, multi-centre, parallel-group, Phase 3 trials with identical design including patients who had moderate-to-severe AD for at least 3 years, and were not adequately controlled by topical treatment3
| STUDY | STUDY DURATION (WEEKS) | NUMBER OF PATIENTS | TREATMENT ARMS | PRIMARY ENDPOINTS |
|---|---|---|---|---|
| SOLO 1 | 16 |
671* |
Initial dose of 600 mg DUPIXENT (two 300 mg injections)/matching placebo on day 1, followed by 300 mg DUPIXENT Q2W as monotherapy/ 300 mg DUPIXENT QW as monotherapy/ matching placebo |
Proportion of patients who achieved both IGA 0/1 (clear/almost clear) and a ≥2-point reduction from baseline at Week 16 (0–4 scale) Proportion of patients who achieved EASI-75 from baseline at Week 16 |
| SOLO 2 | 16 | 708* | ||
| *Patients were ≥18 years of age with moderate-to-severe AD defined by IGA score ≥3, an EASI score ≥16, and a minimum BSA involvement of ≥10%. | ||||
16-week, randomised, double-blind, placebo-controlled, multi-centre, parallel-group, Phase 3 trial including patients who had severe AD for at least 3 years, and were not adequately controlled by, or were intolerant to ciclosporin4
| STUDY | STUDY DURATION (WEEKS) | NUMBER OF PATIENTS | TREATMENT ARMS | PRIMARY ENDPOINTS |
|---|---|---|---|---|
| CAFÉ |
16 |
325* |
Initial dose of 600 mg DUPIXENT (two 300 mg injections)/matching placebo on day 1, followed by 300 mg DUPIXENT + TCS Q2W/ 300 mg DUPIXENT + TCS QW/ matching placebo + TCS |
Proportion of patients who achieved EASI-75 from baseline at Week 16 |
| *Patients were ≥18 years of age with severe AD not adequately controlled, or intolerant to, medium/high potency TCS or oral CsA. Inclusion criteria was defined by IGA score ≥3, an EASI score ≥20, and a minimum BSA involvement of ≥10%. | ||||
AD, atopic dermatitis; BSA, body surface area; CsA, ciclosporin; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; QW, once weekly; Q2W, once every two weeks; TCS, topical corticosteroids.
References
