Delhi: Dupilumab (Dupixent) combined with topical corticosteroids significantly improved the symptoms of severe atopic dermatitis (AD) in children, revealed results from a phase 3 clinical trial.
According to a press release, children aged 6 to 11 years with severe AD who received dupixent combined with topical corticosteroids showed a significant improvement in the measures of overall disease severity, skin clearing, itching and health-related quality of life compared with the use of topical corticosteroids alone.
The double-blind, placebo-controlled evaluated Dupilumab in a combination with topical corticosteroids in 367 children aged 6 to 11 years with severe AD whose disease could not be adequately controlled with topical medications.
All the patients received topical corticosteroids and moisturizers for 16 weeks and were randomized to receive 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.
Key findings include:
- 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.
- Also at week 16, 33% of patients who received dupilumab every 4 weeks and 30% who received dupilumab every 2 weeks achieved clear or almost clear skin vs. 11% in the placebo group.
- With regard to safety, the most common adverse events reported were conjunctivitis, nasopharyngitis, and injection site reactions.
Dupilumab, a fully human monoclonal antibody, that dually inhibits interleukin-4 (IL-4) and IL-13 signalling and is approved for 3 indications:
- Uncontrolled moderate to severe atopic dermatitis for the treatment of patients aged 12 years and older.
- as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma.
- as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis.