The atopic dermatitis is a chronic inflammatory disease, which most often affects children and causes skin rashes that they sting and scaling (eczema). These symptoms compromise the quality of life of the young patients and their parents, since on many occasions it does not even allow them to rest at night. Now, the first study testing a biologic drug (monoclonal antibody), rather than immunosuppressive drugs, for the treatment of moderate to severe dermatitis in infants and children 6 months to 5 years of age shows that it was highly effective in reducing the signs and symptoms of this pathology, according to researchers participating in a new international phase III study led by Northwestern Medicine. The results of the research, which included 31 sites in Europe and North America, are published in The Lancet.
More than half of the children had at least a 75% decrease in signs of eczema and very significant reductions in itching, with a sleep improvement after 16 weeks of treatment with the drug dupilumab, which targets a key immune pathway in allergies.
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 6 months of age.
The children were randomized to receive either a placebo or dupilumab injection, with weight-based dosing, every four weeks for 16 weeks. Only children who did not respond adequately to topical medications could be enrolled and they had to be high severity.
“Preschoolers who constantly scratch themselves, wake up several times a night with their parents, are irritable, and have limitations in doing what other children their age can improve to the extent that they sleep all nightThey change their personalities and have normal lives,” explains the study’s lead author, Dr. Amy Paller, chair of dermatology at Northwestern University Feinberg School of Medicine and attending physician at Ann & Robert H. Lurie Children’s Hospital in Chicago.
It is estimated that approximately 20% of all children under 6 years of age have eczema and that in 85-90% of cases the disease debuted during the first five years of life.
As a result of this study, this drug is now available for infants and preschoolers ages 6 months and up old. Ella has “an outstanding safety profile” and doesn’t even require lab tests before starting the drug, Paller says.
Although one-half to two-thirds of young children with eczema have mild symptoms, which can be treated with corticosteroid creams and moisturizers, the other one-third or more have moderate to severe disease and require more aggressive treatment.
“Until now, all we’ve had to treat the most severe eczema are immunosuppressive drugs, such as oral steroids, which we try to avoid in children, because they are associated with many side effects and are therefore not a preferred treatment. for a chronic skin disease,” says Paller.
For the past several years, a new drug called dupilumab has been available, which is the first “biologic” drug to treat eczema specifically, which means a limited attack on what scientists have discovered is causing the manifestations of eczema. skin disease. This medication has been shown to be effective and safe in studies with adults, adolescents, and other school-age children. “But in the group in which we are most concerned about safety, those under 5 years of age, the test had not been done and therefore the drug was not available,” recalls Paller.
The administration of the drug consists of a monthly injection. “The effect for most of these younger children is dramatic and at least as good as we’ve seen with immunosuppressive drugs,” says Paller.
In addition, this medication has been shown to be effective in treating asthma, gastrointestinal manifestations, and other problems caused by allergiesbut it is not yet approved for these indications in infants and young children.
In fact, 66% of the children in this trial had developed their eczema during the first six months of life, and by the time dupilumab was started, more than 80% had already developed at least one allergic disorder, such as asthma or allergy food.