Dupixent has had a license extension in the EU so that it can now be used to treat severe atopic dermatitis in children from six months of age.
The manufacturer Regeneron described how data from a study in The Lancet, showed that Dupixent treatment plus topical corticosteroids (hydrocortisone 1%) was effective in children under six years of age.
The trial enrolled and randomised 162 children aged six months to six years, to the drug or placebo. In the trial, participants were included if they had an Investigator's Global Assessment (IGA) score of 3 - 4, which represents moderate-to-severe disease.
The drug was given at a dose based on the bodyweight. For instance, if more than 5 kg but less than 15 kg, a dose of 200 mg was given once every four weeks and for children weighing more than 15 kg but less than 30 kg, a dose of 300 mg was given.
The primary endpoint was set as the proportion of participants with an IGA score of 0 or 1 meaning clear or almost clear skin after 16 weeks.
At week 16, there was a 24% difference in IGA scores between Dupixent and placebo and which was statistically significant (p < 0.0001). The study also observed that the drug’s safety profile was generally in line with what might be expected.
In practice, 85-90% of children will develop atopic eczema before the age of five years and in Europe alone, it is estimated that up to 80,000 children aged between six months and five years have uncontrolled severe atopic dermatitis and might therefore benefit from a trial of systemic therapy.
According to the EMA, Dupixent will now be indicated for the treatment of severe atopic dermatitis in children six months to 11 years and who are candidates for systemic therapy.
The drug was approved for the same paediatric population by the FDA in June 2022.