The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (24% of patients treated with DUPIXENT vs 2% with placebo, P<0.001). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (42% of patients treated with DUPIXENT vs 8% with placebo, P<0.001) and ≥4-point improvement in the Peak Pruritus NRS at Week 16 (37% of patients treated with DUPIXENT vs 5% with placebo, P<0.001).2,5
251 adolescents (12-17 years) in AD-1526 (16 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. Adolescents ≥60 kg received DUPIXENT 300 mg Q2W after a 600 mg loading dose, and adolescents <60 kg received 200 mg Q2W after a 400 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, 46% had an IGA score of 3 (moderate), 54% had an IGA of 4 (severe), mean EASI score was 36, and weekly averaged Peak Pruritus NRS was 8 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. The safety profile in adolescents through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT in adolescents observed through Week 52 was consistent with that seen in adults with atopic dermatitis.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.
