Everything You Need to Know About Dupixent

It's the first and only biologic medicine approved to treat moderate to severe atopic dermatitis from infancy to adulthood.

In a press release issued by the French multinational pharmaceutical and healthcare company Sanofi, the U.S. Food and Drug Administration (FDA) has given the green light to the utilization of Dupixent to treat cases of atopic dermatitis. 

Dupixent (dupilumab), the first biologic medication approved by the FDA for children aged 6 months to 5 years with moderate to severe atopic dermatitis "whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable."

WHAT IS DUPIXENT? 

According to the National Eczema Association (NEA), Dupixent is a form of a biologic medication engineered from proteins derived from living cells or tissues. They are designed to "target specific parts of the immune system that contribute to chronic inflammatory diseases such as atopic dermatitis."

"Biologics take an ‘inside out’ approach to treating inflammatory conditions by addressing the issue at the immune system level, the root cause of many diseases," said the NEA.

HOW DOES DUPIXENT WORK? 

NEA explained that Dupixent works by blocking a type of protein called an interleukin, or IL, from binding to their cell receptors. By assisting in our bodies' defense against bacteria or viruses, interleukins support a healthy immune system. Certain ILs may mistakenly attack the body when the immune system is out of control, leading to chronic inflammatory diseases like atopic dermatitis.

Photo from www.dupixent.com/atopicdermatitis/about-dupixent/how-dupixent-works

HOW DO YOU TAKE DUPIXENT?

As do all biologic medications, Dupixent requires injection. NEA explains that a large molecule drug like Dupixent cannot be given in a pill or be applied topically. 

“If given in a pill, our digestive tract will easily break these proteins down and make the drug ineffective… When applied topically, large molecule drugs are unable to penetrate the skin’s surface to carry the medication to the immune system,” they clarified.

Photo taken from www.dupixent.com/atopicdermatitis/about-dupixent/how-dupixent-is-taken

HOW DO I KNOW IF I HAVE MODERATE OR SEVERE ATOPIC DERMATITIS?

Atopic dermatitis, a chronic inflammatory skin condition, is frequently referred to as "eczema," a blanket term for various kinds of skin inflammation. It’s the most common of the many types of eczema, which typically begins in childhood and lasts through adulthood.

The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. People with this skin condition develop red, scaly and crusty bumps in the skin. The degree of skin involvement and the severity of symptoms like redness, itch, and rash that are unaffected by topical medications alone are used to classify atopic dermatitis as moderate to severe. 

Atopic dermatitis can, however, be categorized as moderate or severe if it significantly impairs your quality of life. It's crucial to discuss with your doctor how AD impacts all facets of your life, not just your skin.

IS IT SAFE? 

According to the FDA, the safety and efficacy of Dupixent were established in three placebo-controlled clinical trials with a total of 2,119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medications.

"Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment," said FDA.

HOW ARE THE CLINICAL RESULTS? 

Dupixent was studied in both adults and children 6 months of age and older. 

• FOR ADULTS 

Dupixent was studied in 3 clinical trials with more than 2,100 adults with moderate-to-severe eczema not well controlled with topical prescription treatments. It was first approved by the FDA for this patient population on March 28, 2017.

View the full clinical results here.

• FOR TEENS

Dupixent was studied in a 16-week clinical trial with 251 patients ages 12-17 years with moderate-to-severe eczema not well controlled with topical prescription treatments. It was approved by the FDA for this patient population on March 11, 2019.

View the full clinical results here.

• FOR CHILDREN

Dupixent was studied in a 16-week clinical trial with 367 patients ages 6-11 years with severe eczema not well controlled with topical prescription treatments. It was approved by the FDA for the moderate-to-severe patient population on May 26, 2020.

View the full clinical results here.

• FOR YOUNG CHILDREN

Dupixent was studied in a 16-week clinical trial with 162 patients ages 6 months to 5 years with moderate-to-severe eczema not well controlled with topical prescription treatments. It was approved by the FDA for the moderate-to-severe patient population on June 7, 2022.

View the full clinical results here.

HOW TO GET DUPIXENT?

According to their website, Dupixent is available by prescription only. In several other nations around the world, including the EU and Japan, Dupixent is authorized for a limited number of patients with moderate-to-severe atopic dermatitis and specific cases of asthma.

If you'd like to learn more about their prices, Sanofi Genzyme and Regeneron, manufacturers of Dupixent, have programs to assist with your copay costs. Talk to your doctor first and visit www.dupixent.com to learn more.

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