Biologic Meets Key Endpoints for Pediatric Patients with AD
Dupilumab (Dupixent) was found to improve disease severity and health-related quality of life among adolescents with moderate to severe atopic dermatitis (AD) in a pivotal phase 3 trial, meeting primary and key secondary endpoints.
The randomized, double-blind, placebo-controlled trial included 251 participants from aged 12 to 17 years with moderate to severe AD that was resistant to topical therapies or whom topical therapy was contraindicated. Participants were randomized to either 200 mg or 300 mg of subcutaneous dupilumab every 2 weeks, based on weight, after an initial dose of 400 mg or 600 mg; 300 mg of dupliumab, after an initial dose of 600 mg, every 4 weeks; or placebo every 2 weeks. Therapies were administered for 16 weeks. Primary endpoints included the proportion of participants achieving a score of 0 or 1 (clear or almost clear skin, respectively) on the Investigator’s Global Assessment (IGA) and a 75% or greater improvement in the Eczema Area and Severity Index (EASI) at week 16.
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At week 16, 24% of participants who received weight-based dosing of dupilumab every 2 weeks and 18% of participants who received the fixed-dose dupilumab every 4 weeks achieved IGA score of 0 or 1 compared with 2% of those who received placebo. In addition, 41.5% and 38% of those who received dupilumab every 2 weeks or 4 weeks, respectively, achieved a 75% or greater improvement on EASI compared with 8% of those who received placebo.
Dupilumab every 2 weeks and every 4 weeks was associated with a 66% and 65% improvement, respectively, in the average percent change from baseline EASI scores compared with placebo (24%). On the pruritus numerical rating scale, dupilumab every 2 weeks and every 4 weeks was associated with a 48% and 45.5% improvement, respectively, compared with 19% in the placebo group.
The overall adverse event rate was comparable between the 2-week and 4-week dupilumab treatment groups and placebo (72%, 64%, and 69%, respectively). Among dupilumab treatment groups, there were no serious adverse events or events that lead to discontinuation of therapy.
While rates of injection site reactions and conjunctivitis were higher among the dupilumab treatment groups, skin infections were numerically lower compared with placebo.