Itchy eczema in children is finally relieved

The first study to treat moderate to severe eczema in infants and children 6 months to 5 years old with a biologic drug (monoclonal antibody) rather than immunosuppressive drugs shows that the drug was highly effective in reducing signs and symptoms. moderate eczema symptoms. to severe eczema, report researchers involved in a new international multisite phase III study led by Northwestern Medicine.

A 16-week course of dupilumab, a drug that targets a key immune pathway in allergies, saw more than half of children have at least a 75% reduction in signs of eczema and very significant reductions itching with improved sleep.

This is the first large-scale, randomized, placebo-controlled trial of a monoclonal antibody in any skin disease, including eczema, in children as young as six months old. The study, which included 31 sites in Europe and North America, was published in The Lancet.

​​​​​​​Study: Dupilumab in Children Aged 6 Months to ​​​​​​​. Image Credit: Aisylu Ahmadieva/Shutterstock

“Preschoolers who scratch constantly, wake up several times a night with their parents, are irritable, and markedly reduced in their ability to do what other children their age can do, improve to the extent that they sleep through the night, change personalities, and have normal lives, just like babies and children should,” said study lead author Dr. Amy Paller, chair of dermatology at Northwestern. University Feinberg School of Medicine and attending physician at the Ann & Robert H. Lurie Children’s Hospital in Chicago.

Eczema, also known as atopic dermatitis, is a chronic inflammatory skin condition characterized by red, dry, often oozing and itchy skin that can profoundly affect the lives of affected patients and their families.

It is estimated that 19% or more of all children under the age of six have eczema, and 85-90% of people with eczema overall have the onset of the disease within the first five years of life. life.

Debilitating itching in children leads to sleep disturbances, poor neurocognitive development and, on average, one full night’s sleep lost per week.

“Being able to take this drug will dramatically improve the quality of life for infants and young children who suffer greatly from this disease,” Paller said. “Atopic dermatitis or eczema is much more than just itchy skin. It is a devastating disease. The quality of life of severe eczema – not only for the child but also for the parents – equals many diseases deadly.”

As a result of this study, this drug is now available for infants and preschoolers as young as six months old. What’s more, it has “an exceptional safety profile” and doesn’t even require any lab tests before starting the drug, Paller said.

Although between half and two-thirds of young children with eczema have mild symptoms, which can be treated with steroid ointment and moisturizers, the other third or more have moderate to severe disease and require treatment. more aggressive load.

“So far, all we’ve had to treat more severe eczema are immunosuppressive drugs, such as oral steroids, which we try to avoid in children because they’re associated with many side effects. side effects and therefore are not a preferred treatment for chronic skin disease,” Paller said. “The potential long-term impact on the development of the immune system in young children is also of concern with these immunosuppressants.”

In recent years, a new drug called dupilumab, the first “biological” drug to treat eczema in a targeted manner, i.e. a narrow attack on what scientists have discovered, is causing manifestations of the disease in the skin. This drug has been shown to be effective and safe in studies with adults, adolescents, and other school-aged children.

“But the group in which we’re most worried about safety — the under-5s — weren’t tested and couldn’t get this drug,” Paller said.

The parent or health care provider gives the child a monthly injection to administer the medication.

“The effect for most of these young children is dramatic and at least as good as we’ve seen with risky immunosuppressive drugs,” Paller said.

Potential additional benefit in treating associated allergies

This drug has also been shown to be effective in treating asthma, gastrointestinal manifestations of allergy, and other allergy-mediated problems, but is not yet approved for these indications in infants and young children.

In fact, 66% of the children in this trial had developed eczema within the first six months of life. Additionally, at the time of dupilumab initiation, more than 80% had already developed at least one allergic disorder, such as asthma or food allergy.

“By treating more aggressively to calm immune system activation in these young children with early and severe eczema, we can also reduce the risk of them developing a range of allergic problems, changing their lives beyond the improvement in eczema,” Paller said. “These associated allergic problems most often start after the eczema has started.”

The children were randomized to receive either a placebo injection or dupilumab (dosage based on weight) every four weeks for 16 weeks. Only children who did not respond adequately to topical medications were allowed to enroll, and they had to be very strict even with topical medications.

As a result of the study, Paller said, scientists and doctors can begin to better understand the relationships between eczema and a variety of allergic disorders. Additionally, they may consider the possibility of using this medication for other conditions that affect these very young children.

The trial was sponsored by Regeneron Pharmaceuticals, Inc. and Sanofi, who jointly developed dupilumab.

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Source: Northwestern University

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