Atopic Dermatitis: Dupilumab gets FDA approval for pediatric patients

Key findings of the trial include:

• Results at week 16 showed a significantly greater proportion of patients treated with dupilumab achieved clear or almost clear skin, as measured by Investigator's Global Assessment (IGA; primary end point) (30% for dupilumab every 4 weeks and 39% for dupilumab every 2 weeks vs 13% and 10% for placebo, respectively).
• A greater proportion of patients treated with dupilumab also achieved EASI (Eczema Area and Severity Index)-75 (75% for dupilumab every 4 and 2 weeks vs 28% and 26% for placebo, respectively) and EASI-90 (46% for dupilumab every 4 weeks and 36% for dupilumab every 2 weeks vs 7% and 8% for placebo, respectively).
• Treatment with dupilumab resulted in a greater proportion of patients with at least a 4-point reduction in itch intensity, as assessed by the Peak Pruritus Numerical Rating Scale (54% for dupilumab every 4 weeks and 61% for dupilumab every 2 weeks vs 12% and 13% for placebo, respectively).
• The safety profile of dupilumab in patients aged 6 to 11 years was similar to that seen in patients aged ≥12 years with atopic dermatitis in previous studies.
• The most common adverse reactions included upper respiratory tract infections, injection site reactions, nasopharyngitis, conjunctivitis, vomiting, and fever.