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Dupixent shows positive results in children with severe atopic dermatitis
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Children aged 6 to 11 years with severe atopic dermatitis assigned dupilumab and topical corticosteroids significantly improved in measures of overall disease severity, skin clearing, itching and health-related quality of life vs. topical corticosteroids alone in a phase 3 trial.
The randomized, double-blind, placebo-controlled trial evaluated Dupixent (dupilumab; Regeneron Pharmaceuticals, Sanofi) combined with topical corticosteroids in 367 children aged 6 to 11 years with severe atopic dermatitis whose disease could not be adequately controlled with topical medications, according to a press release.
For the 16-week treatment period, all patients received topical corticosteroids and were randomly assigned to one of three treatment groups: dupilumab subcutaneous injection 300 mg every 4 weeks and an initial dose of 600 mg; dupilumab 100 mg or 200 mg every 2 weeks (based on weight) and an initial dose of 200 mg or 400 mg; and placebo every 2 or 4 weeks.
At week 16, 70% of patients treated with dupilumab 300 mg every 4 weeks and 67% of patients treated with dupilumab every 2 weeks (dose based on weight) achieved 75% or greater skin improvement on the Eczema Area and Severity Index (EASI-75) vs. 27% for placebo (P < .0001 for both).
Also at week 16, 33% of patients who received dupilumab every 4 weeks (P < .0001) and 30% who received dupilumab every 2 weeks (P = .0004) achieved clear or almost clear skin vs. 11% in the placebo group, according to the release
Additionally, Regeneron and Sanofi announced that the European Commission extended marketing authorization for dupilumab in the EU to include adolescents aged 12 to 17 years with severe to moderate atopic dermatitis who are candidates for systemic therapy, according to a press release.
Dupilumab is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and IL-13 proteins, according to the release.
The safety data in this trial were similar to the previously documented safety profile of dupilumab in older populations.
In the U.S., dupilumab is currently approved in patients aged 12 years and older with moderate to severe atopic dermatitis as well as moderate to severe asthma and adults with severe chronic rhinosinusitis with nasal polyposis.