- Dupilumab is associated with significant treatment response compared with placebo in adolescents with inadequately controlled moderate-to-severe atopic dermatitis (AD), according to a multicentre, randomised, controlled, phase 3 trial.
Why this matters
- These phase 3 trial results led to approval of dupilumab in this patient population.
- Dupilumab was associated with a significantly higher rate of ≥75% improvement in the Eczema Area and Severity Index (EASI-75) compared with placebo (41.5% for Q2W, 38.1% for Q4W, 8.2% for placebo; P<.001>
- Dupilumab was associated with a significantly higher rate of Investigator’s Global Assessment 0/1 compared with placebo (24.4% for Q2W, 17.9% for Q4W, 2.4% for placebo; P<.001>
- Dupilumab was associated with numerically higher rates of conjunctivitis (9.8% for Q2W, 10.8% for Q4W, 4.7% for placebo) and injection-site reactions (8.5% for Q2W, 6.0% for Q4W, 3.5% for placebo) compared with placebo.
- 251 adolescent patients with moderate-to-severe AD inadequately controlled with topical medications or for whom topical therapy was inadvisable were included and randomly assigned 1:1:1 to receive dupilumab Q2W, dupilumab Q4W, or placebo.
- Funding: Sanofi, Regeneron Pharmaceuticals Inc.
- Relatively short treatment time (16 weeks).