This site is intended for health professionals only

Dupilumab recommended for expanded EU approval for severe atopic dermatitis in children from 6 months

In a press release from Regeneron, the company described how data from a study in the Lancet showed that dupilumab treatment plus topical corticosteroids (hydrocortisone 1%) was effective in children under 6 years of age. The Lancet trial enrolled and randomised 162 children aged 6 months to 6 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 > 5 kg but < 15 mg, a dose of 200 mg was given once every 4 weeks and for children weighing > 15 kg but < 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 (i.e., 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.

The press release describes how, in practice, 85 to 90% of children will develop atopic dermatitis before the age of 5 years and, in Europe alone, it is estimated that up to 80,000 children aged between 6 months and 5 years have uncontrolled severe disease 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 6 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.






Be in the know
Subscribe to Hospital Pharmacy Europe newsletter and magazine

×