A Phase 3 trial of Dupixent (dupilumab; Sanofi and Regeneron) in adolescent patients found that monotherapy resulted in significant improvements in the signs and symptoms of atopic dermatitis. The findings were presented at the recent European Academy of Dermatology and Venereology (EADV) Congress.
Dupixent is an interleukin-4 and interleukin-13 inhibitor and is currently approved to treat moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies.
The Phase 3 trial enrolled 251 patients aged 12–17 years old with moderate-to-severe atopic dermatitis, whose disease was not adequately controlled by prescription topical medications or for whom topical treatment was medically inadvisable. Study patients were randomized into 3 groups for a control period of 16 weeks.
The first group was treated with Dupixent 200mg or 300mg every 2 weeks, based on weight (with an initial dose of 400mg or 600mg respectively). The second group was treated with Dupixent 300mg every 4 weeks (with an initial dose of 600mg). The third group was treated with placebo every 2 weeks. The primary endpoint was the proportion of patients with an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at week 16.
Results showed that 24%, 18% and 2% of the first group, second group, and placebo group achieved the primary endpoint of IGA 0 or 1, respectively (P <.001). A secondary endpoint measured a 75% improvement in Eczema Area and Severity Index (EASI-75) at 16 weeks. Data further demonstrated significant improvements in this efficacy outcome with 41.5% in the first group, 38% in the second group, and 8% in the placebo group achieving EASI-75 (P <.001).
In addition, patients in the Dupxient every 2 weeks group and Dupixent every 4 weeks group saw a 48% and 45.5% improvement, respectively, in average percent change from baseline in the pruritus numerical rating scale (NRS) vs 19% in the placebo group (P <.001).
Results from this trial in adolescents will form the basis of regulatory submissions for patients ages 12 to 17, according to the Companies.
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