The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (38% and 36% of patients treated with DUPIXENT vs 10% and 9% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 39% of patients treated with DUPIXENT + TCS vs 12% with placebo + TCS in CHRONOS, P<0.0001). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (51% and 44% of patients treated with DUPIXENT vs 15% and 12% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 69% of patients treated with DUPIXENT + TCS vs 23% with placebo + TCS in CHRONOS, P<0.0001) and ≥4-point improvement in the Peak Pruritus NRS at Week 16 (41% and 36% of patients treated with DUPIXENT vs 12% and 10% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 59% of patients treated with DUPIXENT + TCS vs 20% with placebo + TCS in CHRONOS, P<0.0001).2,6,7
917 adults in SOLO 1 and SOLO 2 (16 weeks each) and 421 adults in CHRONOS (52 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. All patients in CHRONOS were treated with concomitant TCS. All patients who received DUPIXENT were given 300 mg Q2W after a 600 mg loading dose. Patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 52% had an IGA score of 3 (moderate), 48% had an IGA of 4 (severe), mean EASI score was 33, and weekly averaged Peak Pruritus NRS was 7 on a scale of 0 to 10.2
The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.2
BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.
