A new drug therapy to treat moderate to severe eczema in young children has been shown to be “safe and highly effective” in clinical trials. In an international study, published in the journal The Lancet, dupilumab was shown to improve the severity of the skin condition within two weeks in patients aged six months to six years.
The children and their parents also reported improved sleep and quality of life. Based on the findings, doctors believe the treatment may be approved for children under the age of six in the UK soon, after it was adopted in the US in June this year.
Dupilumab is already licensed in the UK for adults and children aged six to 18. Dr Peter Arkwright, from the University of Manchester, who is principle investigator for the Manchester arm of the trial, 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. The fact that infants and young children with moderate to severe eczema are inadequately controlled with creams means they have a high unmet medical need.
“We’re so delighted that dupilumab has provided clinically meaningful improvement, with an acceptable safety profile. These pivotal trial results strongly support the global approval of dupilumab in infants and children with eczema.
“It will revolutionise clinical practice worldwide.”
The phase three clinical trial, which was sponsored by Biotech companies Regeneron and Sanofi, involved 162 children from around the globe, including patients at Manchester Children’s Hospital. Of the 162 participants, 83 were given an injection of dupilumab, and 79 a placebo, every four weeks, alongside the standard therapy of a low-potency steroid cream for 16 weeks.
Results showed that 28% of patients receiving dupilumab achieved a global skin score of 0 or 1, indicating complete and almost complete healing of the skin at week 16. In addition, more than half (53%) of the children showed at least a 75% reduction in signs of eczema and highly significant reductions in itch, alongside improved sleep.
Eczema is a condition that causes the skin to become itchy, dry and cracked. It is more common in children, often developing before their first birthday and is usually a long-term condition, although it can improve significantly, or even clear completely, in some children as they get older.
