A biologic therapy for very young children with a moderate to severe form of a common skin disease, eczema, has been shown to be safe and effective in an international study involving clinical scientists at the University of Manchester.
Sponsored by biotech companies Regeneron and Sanofi, the study of dupilumab in poorly controlled eczema is the first large-scale study of a monoclonal antibody in any skin disease in patients aged six months to six years.
The study, the results of which are published in The Lancet, found that the drug significantly improved the severity of the condition by reducing skin itching and pain within two weeks.
Manchester-based principal investigator and academic pediatrician Dr. Peter Arkwright has been studying the use of dupilumab in children with severe eczema, also known as atopic dermatitis, at the Royal Manchester Children's Hospital Clinical Research Center since August 2015.
A total of 83 patients received a subcutaneous injection of dupilumab and 79 received a placebo every four weeks, and continued standard therapy with a low-potency steroid cream for 16 weeks.
The experts found:
- 28% of patients who received dupilumab achieved a global skin score of 0 or 1, meaning clear or nearly clear skin at 16 weeks.
- In 53% of patients, the Eczema Area and Severity Index (EASI) improved by 75% at week 16 from baseline.
- Conjunctivitis occurred slightly more frequently with dupilumab compared to placebo (5% vs. 0%), but no adverse events associated with dupilumab were serious and did not lead to discontinuation of treatment.
Eczema is a chronic inflammatory skin disease with a prevalence of 20% or higher in children younger than six years of age.
It is characterized by an itchy red rash, especially on the face and the bends of the elbows and knees, and an increased risk of skin infection.
Follow NEWS.am Medicine on Facebook and Twitter
month
week
day