A biological therapy for very young children with a moderate to severe form of a common skin condition has been shown to be safe and effective in an international trial involving University of Manchester clinical scientists working at the Royal Manchester Clinical Trials Centre. Childrens Hospital.
Sponsored by the biotech companies Regeneron and Sanofi, the study of dupilumab in poorly controlled patients eczema is the first large-scale randomized double-blind trial of a monoclonal antibody for any Skin illness in patients from six months to six years.
The study, published in the lancet showed that the drug greatly improved the severity of the condition, reducing skin itching and pain within two weeks.
It also significantly improved the sleep of the patients and the quality of life of the patients and their parents.
Doctors hope the international study of 162 patients will ensure that this treatment is soon approved for British children, following its adoption in the United States in June this year.
Manchester principal investigator and academic paediatrician Dr. Peter Arkwright has been investigating the use of dupilumab in children with severe eczema, also known as atopic dermatitis—at the Clinical Research Facility (CRF) at the Royal Manchester Children Hospital since August 2015.
Although the therapy is already licensed in the UK for adults and children aged 6 to 18, the researchers see positive results for Small children like the icing on the cake.
Patients in the trial were enrolled at 31 hospitals, clinics, and academic institutions in Europe and North America from June 2020 to February 2021.
A total of 83 patients received a subcutaneous injection of dupilumab and 79 a placebo every four weeks, in addition to continuing standard therapy with a low-potency steroid cream for 16 weeks. Independent raters rated the level of inflammation.
- Twenty-eight percent of patients who received dupilumab achieved a skin global score of 0 or 1, indicating clear or nearly clear skin at week 16.
- 53% of patients experienced a 75% improvement from baseline in Eczema Area and Severity Index (EASI) at week 16.
- Conjunctivitis was slightly more common with dupilumab than with placebo (5% vs. 0%), however, no dupilumab-related adverse events were serious or led to treatment discontinuation.
Eczema is a chronic inflammatory skin disease with a prevalence of 20% or more in children under six years of age.
It is characterized by an itchy red rash, particularly on the face and in the creases of the elbows and knees, as well as an increased risk of skin infection.
Dr 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 disrupted.”
“The fact that infants and young children with moderate to severe eczema are not adequately controlled with creams means that they have a high unmet medical need. We are very pleased that dupilumab has provided clinically significant improvement, with a profile of acceptable security.
“These pivotal trial results strongly support the global approval of dupilumab in infants and children with eczema. It will revolutionize clinical practice worldwide.”
Amy S Paller et al, Dupilumab in children aged 6 months to less than 6 years with uncontrolled atopic dermatitis: a phase 3 randomized, double-blind, placebo-controlled trial, the lancet (2022). DOI: 10.1016/S0140-6736(22)01539-2, dx.doi.org/10.1016/S0140-6736(22)01539-2
university of manchester
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