The U.S. Food and Drug Administration approves first biologic for treatment of eczema

On March 28th 2017, the U.S. Food and Drug Administration (FDA) approved a new drug called dupilumab (brand name: Dupixent) for the treatment of adults with moderate-to-severe atopic dermatitis (also known as atopic eczema) that is not adequately controlled with topical treatment, or for whom topical treatments are not appropriate.

This new drug is administered by injection under the skin and can be used either with or without topical corticosteroids.

What is atopic dermatitis?
Atopic dermatitis is a common, chronic, non-contagious inflammatory skin condition, characterised by red, dry, itchy skin, which can sometimes weep, become blistered, crusted and thickened. It can start at any time of life but is most common in childhood, affecting approximately 1 in 5 children.

Genetic, immune and environmental factors are thought to play a role in the development of atopic dermatitis. The major symptom is an intense itch. Scratching only provides temporary relief, and leads to more itching and scratching (described as the itch-scratch cycle), which worsens eczema, interferes with sleep and reduces the patient’s quality of life.

Despite the devastating effect that this condition can have on quality of life, there have been no significant changes in the way it has been treated in the last 15 years.

Evidence of safety and efficacy
FDA approval of dupilumab follows results from three phase 3 clinical trials involving 2,119 adult patients with inadequately controlled moderate-to-severe atopic dermatitis. The trials evaluated the effects of dupilumab as a single therapy, and when used in combination with topical corticosteroids.

Results show dupilumab to have good safety and efficacy, with improvements in skin clearing, severity of eczema, symptoms (itch) and quality of life. The most common side effects included injection site reactions, eye and eyelid inflammation, and cold sores on the lips or in the mouth.

How does dupilumab work?
Dupilumab is a targeted therapy believed to work by blocking the actions of two key proteins [interleukin-4 (IL 4) and interleukin-13 (IL 13)] involved in the inflammatory response, which plays a part in the development of atopic dermatitis.

The future
This new biologic will extend the range of treatments available for patients with atopic dermatitis, and potentially heralds the beginning of a new era of life changing treatments for this distressing condition.

For more information on eczema and atopic dermatitis visit our eczema section.