A biologic therapy for very young children with moderate to severe eczema (or atopic dermatitis) has been shown to be safe and effective in an international trial.
Sponsored by Regeneron and Sanofi, the study of dupilumab in poorly controlled eczema is the first large-scale randomised double-blind trial of a monoclonal antibody for any skin disease in patients aged six months to six years.
The study, published in The Lancet showed that the drug reduced skin itch and pain within two weeks, as well as improving patients’ sleep, and the quality of life of patients and their parents.
The therapy is already licensed in the UK for adults and children aged six to 18, and was approved by the FDA in June 2022 for use in younger children.
Principle Investigator for Manchester and Academic Paediatrician Peter Arkwright, has been investigating the use of dupilumab in children with severe eczema at Royal Manchester Children Hospital’s Clinical Research Facility (CRF) since August 2015.
Arkwright said: “Young children and infants who have moderate-to-severe eczema have a substantially reduced quality of life. It’s also incredibly stressful for their families, particularly as children’s sleep is so disturbed.
“These pivotal trial results strongly support the global approval of dupilumab in infants and children with eczema. It will revolutionise clinical practice worldwide.”
