Dupixent (dupilumab) has now been recommended for approval in the EU to treat patients with severe atopic dermatitis from 6 months of age
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.