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FDA Approves Adult Eczema Drug for Use with Children

The injectable drug, Dupixent, is self-administered every other week.

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The drug will be given to teens who haven’t responded well enough to other treatments. Getty Images

Relief is on the way for teenagers who have eczema.

The Food and Drug Administration (FDA) has approved injectable dupilumab (Dupixent) for eczema patients aged 12 to 17 years who don’t respond well enough to topical treatments.

The drug, initially approved for adult use in 2017, is self-administered every other week after the first dose is given by a healthcare provider.

“For patients with really severe eczema, up to now we didn’t have anything to give them that’s safe for long-term use,” Dr. Emma Guttman, vice chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York whose research and clinical trials helped lead to FDA-approval, told Healthline.

“Oral prednisone can have terrible side effects,” she explained, “and immune suppressants can cause serious issues with long-term use. Of course, phototherapy (light treatment) is safe but must be done three times a week, which won’t work with most children’s schedule.”

Dupilumab comes in prefilled syringes and is available in two doses: 200 mg and 300 mg. It was developed by Regeneron Pharmaceuticals and Sanofi Genzyme.

Dr. Richard Torbeck, a board-certified dermatologist with Advanced Dermatology PC said “Acute dermatitis is a multitude of conditions that can be lumped together.”

“The main dermatitis Dupixent treats is atopic dermatitis, when your skin reacts against itself,” he explained to Healthline. “An unknown factor in the skin leads to an immune response that causes inflammation. Certain proteins called interleukin 4 and 13 (IL4/13) become more active in the skin causing a red, itchy, scaly rash. Dupilumab works by blocking IL4/13 on the cells causing the immune response.”

Previous eczema therapies, such as azathioprine, cyclosporine, methotrexate, and corticosteroids are immunosuppressants. They work by reducing the whole body’s normal immune response.

When used long term, immunosuppressive drugs increase the risk of infection, cardiovascular disease, and even cancer.

Dupilumab is different in that it’s a biologic drug.

According to the FDA, biologics are genetically engineered from proteins derived from living cells. They can be designed to target specific parts of the immune system that contribute to inflammatory diseases such as eczema and other forms of dermatitis.

“It’s not at all immunosuppressive. Because it just targets the lymphocytes, it acts as an immune corrector rather than an immune suppressor. It corrects a deficiency the patient has,” said Guttman.

Although dupilumab won’t resolve eczema symptoms immediately, experts say it will noticeably improve the appearance of skin within the first month.

“We found in the trials that, to resolve about 75 percent of the eczema took about 4 weeks. To see maximum clearance of symptoms will take about 16 weeks. However, there will occasionally be extremely severe patients that may need another four or eight weeks. But usually by 16 weeks, patients will see almost or completely clear skin.”

There is some evidence that eczema can be prevented if the skin is kept moisturized from a young age.

A 2014 study in The Journal of Allergy and Clinical Immunology found that using emollient therapy with creams, lotions, and moisturizing soap from birth is a safe and effective approach to prevent eczema and other forms of dermatitis.

“At this time, the best way to prevent dermatitis or eczema is through lifestyle modifications like eating healthy, avoiding perfume, scented lotions, and detergents. Also, check for any food allergies, control any asthma or seasonal allergies, and follow your dermatologist’s treatment recommendations,” said Torbeck.

“It’s an exciting time as dermatitis treatments are rapidly advancing to the forefront like other recent developments in the field, like psoriasis,” he added.

Eczema can be painful and, in extreme cases, disfiguring. It’s a chronic condition with no known cure.

Although dupilumab won’t cure the condition, it will help damaged skin to heal and alleviate symptoms.

According to Guttman, patients taking the drug regularly will see significant reduction if not a complete reversal of symptoms.

She said many patients have returned to normal life and, if it wasn’t for an injection every two weeks, they likely wouldn’t remember they had eczema.

In addition, there are other treatments on the horizon.

“Next, we will think about a cure. But right now, there are drugs in development that may only need to be taken once every three months. This concept is only starting to be tested,” Guttman-Yassky said.

The FDA has approved injectable dupilumab (Dupixent) for eczema patients aged 12 to 17 years who don’t respond sufficiently to topical treatments. It was approved for adults in 2017.

The drug is an injectable that is self-administered every other week after the first dose is given by a healthcare provider.

Unlike previous treatment options, dupilumab will not suppress the immune system, making it safe for long-term use. Patients can expect to see significant improvement in symptoms after four weeks.

Eczema is a chronic condition and no cure has yet been found. Researchers are currently working on even longer-acting drugs that could stretch the time between doses to three months.


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