Atopic Dermatitis: Dupilumab gets FDA approval for pediatric patients
USA: Dupixent (dupilumab) has received another approval from the US Foood and Drug Administration (FDA) to be used in children aged 6 to 11 years with moderate-to-severe atopic dermatitis. Previously, Dupixent was approved only for patients aged ≥12 years for this indication.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 and interleukin-13 proteins. It is prescribed in two doses based on weight: 300 mg every 4 weeks for children between 15 kg and 30 kg and 200 mg every 2 weeks for children between 30 kg and 60 kg.
The approval was based on results from a phase 3 trial that compared the efficacy and safety of dupilumab to placebo in 367 patients aged 6 to 11 years with severe atopic dermatitis whose disease could not be adequately controlled with topical medications.
In this trial, patients were randomized to receive 1 of 3 treatments for 16 weeks: dupilumab subcutaneous injection 300mg every 4 weeks (with an initial dose of 600mg); dupilumab 100mg (<30kg) or 200mg (≥30kg) every 2 weeks (with an initial dose of 200mg or 400mg, respectively); or placebo every 2 or 4 weeks. Each group also received background treatment with topical corticosteroids and moisturizers.
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.
"This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate to severe atopic dermatitis. This young, vulnerable population struggles with debilitating symptoms and disease covering over half of their body, impacting them and their families who spend countless hours helping them manage their disease," George D. Yancopoulos, co-founder, president and chief scientific officer at Regeneron, said in the release.