Study finds biological drug ‘highly effective’ in reducing symptoms – ScienceDaily

The first study to treat moderate to severe eczema in infants and children aged 6 months to 5 years using a biologic drug (monoclonal antibodies) instead of immunosuppressive drugs, showed that the drug was very effective in reducing the signs and symptoms of moderate to severe eczema, Report of researchers participating in the new Northwestern Medicine-led international multi-site Phase III study.

A 16-week course of dupilumab, a drug that targets a key immune pathway in allergies, resulted in more than half of the children having at least a 75% reduction in signs of eczema and a significant reduction in itch 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 less than 6 months of age. The study, which included 31 sites in Europe and North America, will be published on September 15 scalpel;

“Preschoolers who scratch constantly, get up several times a night with their parents, are irritable and have markedly limited ability to do what other children their age can do, get so good that they sleep through the night, change their personalities and have a normal life.” “Life is as it should be for babies and children,” said study lead author Dr. Amy Baller, chief of dermatology at Northwestern University Feinberg School of Medicine and attending physician at Ann and Robert H. Laurie Children’s Hospital in Chicago.

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

It is estimated that 19% or more of all children under 6 years of age have eczema and 85 to 90% of individuals with eczema generally have an onset within the first 5 years of life.

Children’s debilitating itch leads to disturbed sleep, impaired neurocognitive development, and, on average, the loss of an entire night of sleep per week.

“The ability to take this drug will greatly improve the quality of life for infants and young children who are severely affected by this disease,” Baler said. “Atopic dermatitis or eczema is so much more than just itchy skin. It’s a devastating disease. The quality of life for severe eczema—not only for children but also for parents—is equivalent to many life-threatening illnesses.”

As a result of this study, this drug is now available for infants and preschoolers up to 6 months of age. It has an “outstanding safety profile” and doesn’t even require any lab tests before starting treatment, Baler said.

Although half to two-thirds of young children with eczema have mild symptoms, which can be dealt with with steroid ointment and moisturizers, another third or more have moderate to severe disease and require more aggressive management.

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

Over the past few years, a new drug called dupilumab has become available, and it’s the first “biological” drug to treat eczema in a targeted manner, meaning a narrow attack on what scientists have found causes manifestations of the disease in the skin. . This drug was found to be effective and safe in studies of adults, then adolescents, and then other school-age children.

“But the group that we are most concerned about with safety – those under 5 – have not been tested and have not had access to this drug,” Baller said.

The parent or health care provider gives the child a monthly dose to give the medicine.

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

Possible additional benefit by treating concomitant allergies

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

In fact, 66% of the children in this trial developed eczema within the first six months of their lives, and by the time they started taking the drug, more than 80% had already developed at least one allergic disorder, such as asthma or food allergy. .

“By treating more aggressively to calm the activation of the immune system in these young children with severe early eczema, we can also reduce their risk of developing a range of allergic problems, changing their lives beyond improving eczema,” Baller said. “The associated allergy issues often start after the onset of eczema.”

Children were randomly assigned to receive either a placebo or dupilumab (weight-based dose) injection every four weeks for 16 weeks. Only children who did not respond adequately to the topical medication were allowed to enroll, and had to be in a high-risk condition, even with the topical medication.

As a result of the study, Baler said, scientists and clinicians can begin to better understand the relationships between eczema and a variety of allergic disorders and can consider the possibility of using this drug for other disorders affecting these very young children.

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

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