The Food and Drug Administration (FDA) has expanded the approval of Dupixent® (dupilumab; Regeneron and Sanofi) to include patients aged 6 to 11 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Previously, Dupixent was only approved for patients aged ≥12 years for this indication.
The approval was based on data 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. 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.
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).
Moreover, 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.
Dupixent, an interleukin-4 receptor alpha antagonist, is also indicated for use as add-on maintenance treatment in patients aged 12 years and older with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma and as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis.
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