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FDA Approves Biologic for Adolescents with Eczema


The FDA approved dupilumab (Dupixent) for the treatment of moderate to severe atopic dermatitis (AD) in patients aged 12 to 17 years whose disease is not adequately controlled with topical therapies or who are unable to receive topical therapies.


Dupilumab, an IL-4 and IL-13 inhibitor, is administered every other week following an initial loading dose either in a clinic or at home after training by a health care professional. It is a pre-filled syringe available in 2 doses: 200 mg and 300 mg. The biologic was first approved for adults with inadequately controlled moderate to severe AD in 2017.

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A pivotal phase 3 trial evaluated the safety and efficacy of the biologic among adolescent participants. After 16 weeks, 66% of participants who received dupilumab experienced improvements in the Eczema Area and Severity Index compared with 24% of those who received placebo. More than 10 times as many participants achieved clear or almost clear skin after 16 weeks of treatment with dupilumab compared with placebo on the Investigator Global Assessment scale (24% vs 2%) . In addition, 37% of participants treated with dupilumab achieved clinically meaningful improvement in itch on the Peak Pruritus Numerical Rating Scale compared with 5% of those treated with placebo.


The safety profile among adolescents was similar to adults with AD and consistent through week 52. Common adverse events included injection site reactions, eye and eyelid inflammation (redness, swelling, and itch), oropharyngeal pain, and cold sores in the mouth or on the lips.


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