FDA Approves Dupixent (Dupilumab) as First Biologic Atopic Dermatitis Treatment for Kids 5 and Under

Doctors were already prescribing the medication to adults, teens, and older children with moderate to severe disease. Now they can consider it for their youngest patients with intense skin inflammation and itch.

Dupixent Approved for Children 6 Month and Up
Dupixent (dupilumab) is now okayed for children as young as 6 months.Courtesy of Sanofi and Regeneron Pharmaceuticals

One of the most vexing things about having a young child with atopic dermatitis (eczema) is figuring out how to help them when topical treatments don’t work. Now there’s an entirely new option to try with Dupixent (dupilumab), a once-monthly injection that parents can give kids at home.

In June 2022 the U.S. Food and Drug Administration (FDA) approved Dupixent to treat moderate-to-severe atopic dermatitis in children 6 months to 5 years old who haven’t achieved enough symptom relief with prescription corticosteroid creams or ointments, according to a statement from the drug’s developers, Sanofi and Regeneron.

More than 1 in 10 Americans have atopic dermatitis, which is much more common in children and typically develops before kids are 5 years old, according to the American Academy of Dermatology (AAD).

Around a third of all children in the United States with atopic dermatitis experience moderate to severe disease, per the National Eczema Association (NEA).

“Atopic dermatitis is a highly prevalent disease associated with significant disease burden on the patient and caregiver and with multiple studies demonstrating its marked negative impact on quality of life and high economic cost,” says Zelma Chiesa Fuxench, MD, an assistant professor of dermatology at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

“However, treatment options for patients with atopic dermatitis, particularly very young pediatric patients such as those under age 5, are limited, and until recently, we had no FDA-approved options for this age group,” Dr. Fuxench says.

For Some Kids With Atopic Dermatitis, Even Prescription Creams Aren’t Enough

In babies and young children, atopic dermatitis produces rashes that can feel dry, raw, and scaly, according to the AAD. Affected areas can cause intense itching and ooze or weep fluid. It’s not uncommon for babies to develop skin infections, have trouble sleeping, or act fussy when they have eczema.

For children with milder cases, baths with gentle soaps immediately followed by moisturizer can help prevent symptom flare-ups and soothe skin, according to the NEA. Adding a half cup of bleach to a full tub of water can sometimes reduce the inflammation that exacerbates eczema symptoms.

Over-the-counter remedies like petroleum jelly or mild corticosteroid creams or ointments can also sometimes control symptoms, according to the NEA. Stronger prescription versions of topical corticosteroids are also approved for use in babies and toddlers.

Dupixent offers a different option. First approved for adults about five years ago, and more recently in adolescents and children older than 5, Dupixent is in a family of medicines known as biologics, which are drugs derived from living cells or tissues that are designed to target specific parts of the immune system.

An overactive immune system can contribute to chronic inflammatory diseases like atopic dermatitis. According to the NEA, Dupixent calms the immune system by blocking a type of protein called an interleukin from binding to cell receptors.

More Than Half the Kids in Trials Experienced a 75 Percent Reduction in Disease Severity

In a clinical trial reviewed by the FDA as part of the approval process for patients under 5 years old, patients used topical corticosteroids alone or combined with Dupixent every four weeks for 16 weeks. More than half the kids treated with both topical corticosteroids and Dupixent achieved at least a 75 percent reduction in disease severity by the end of the trial, according to data shared by the companies selling the drug.

With topical corticosteroids plus Dupixent, 28 percent of children achieved completely or nearly clear skin by the end of the trial, compared with just 4 percent of the kids who only used topical corticosteroids, according to data from the companies. And, 48 percent of patients on topical corticosteroids and Dupixent experienced a clinically meaningful reduction in itching, compared with 9 percent of those who only used topical corticosteroids.

“It is the itch that severely adversely affects children’s sleep and thus adversely affects their activities or daily living,” says Saxon Smith, PhD, a dermatologist and a clinical professor at the Australian National University Medical School in Canberra.

“Rectifying this with effective disease control can be transformational in the lives of these young patients,” Dr. Smith says.

Side effects of Dupixent after one year appeared similar to what’s been seen with older patients with atopic dermatitis, according to company data. In patients 6 months to 5 years old, 5 percent of trial participants developed hand, foot, and mouth disease, a common ailment among young children, and 2 percent developed skin papillomas, which are noncancerous tumors on the skin.

These side effects didn’t cause young patients to stop treatment with Dupixent in the trial, according to the companies.

“Overall, dupilumab has demonstrated a consistently good safety profile across populations including very young children, and studies in adults have shown that this safety is sustained through time,” Dr. Fuxench says. “However, more long-term data is still needed, particularly for younger children for whom this drug has been recently approved.”

Will Babies and Children Outgrow the Need for Treatment?

One open question is how long younger children might need to stay on Dupixent. Adults with moderate to severe atopic dermatitis may need to remain on this drug for years, if not for their entire lives, in order to sustain symptom relief, Fuxench notes.

“For young children, this may be a whole different ball game for many reasons,” Fuxench says. Some younger patients might outgrow their disease, ending the need for this medication. It’s also possible that taking Dupixent early in life might prevent eczema from worsening in the future, limiting the need for lifelong treatment.

Despite the uncertainty around long-term usage, it makes sense for parents of young children with eczema to ask their doctor about Dupixent if kids’ symptoms are poorly controlled by other interventions, Fuxench advises.

“I do not think that for the majority of patients dupilumab will be the first-line option, as most pediatric patients have mild disease that can be managed with a gentle skin care regimen and occasional use of prescription topical therapies,” Fuxench says. “But it is a treatment option that can bring relief to those whose disease is poorly controlled.”