The monoclonal antibody is safe and well tolerated in children under age six who have atopic dermatitis.
Young kids with atopic dermatitis now have a new hope, thanks to new research showing the monoclonal antibody dupilumab appears to be safe and effective.
The PBAC recommended the drug for severe atopic dermatitis in patients under 12 in March this year, but it is not yet listed for children under the age of six and evidence around its safety and efficacy has been limited.
But this new phase III randomised controlled trial, published in The Lancet found that dupilumab (Dupixent, Sanofi) provided clinically meaningful and statistically significant improvements compared to a placebo in outcomes such as the extent and severity of atopic dermatitis, pruritus and skin pain.
Before starting treatment, nearly 30% of study participants needed systemic immunosuppressants and around 80% had one or more comorbid conditions, including asthma and food allergies. This highlighted the âsubstantial unmet medical need for efficacious and safe treatment options for this populationâ, the authors said.
Researchers randomly assigned the 160 young children to receive either a 200mg or 300mg dupilumab or placebo subcutaneous injection every four weeks. They found that at week 16 of treatment, more than one in four patients in the dupilumab group had IGA score of 0â1, which represents clear or almost clear skin, compared to one in 25 children in the placebo group.
Similarly, half of the children taking the monoclonal antibody achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI-75), compared to one in 10 children taking the placebo. The incidence of skin infection was also halved with dupilumab compared to placebo.
Adverse events, most commonly atopic dermatitis exacerbation, nasopharyngitis and upper respiratory tract infection, were non-serious and similar across the groups, the authors reported.
Dupilumab has not been actively contraindicated in children, but there has been limited research data on its safety and efficacy in younger patients. While it has now been shown as suitable for all ages, instigation and supervision by a dermatologist is still required according to the Product Information.
âDupixent is currently TGA-registered for the treatment of severe atopic dermatitis in patients aged 6 to 11 years,â a spokeswoman for Sanofi told TMR in a statement.
âFor patients 12 years and over Dupixent is indicated for treatment of moderate to severe atopic dermatitis.â
