ACCORDING to the results of a new Phase III, multisite, international study, a biologic drug has been shown to be effective in the reduction of symptoms of moderate-to-severe eczema in children and infants aged 6 months to 5 years old. The study included 31 sites in Europe and North America and is the first extensive randomised, placebo-controlled trial of a monoclonal antibody on skin diseases such as eczema in children.
Eczema, also known as atopic dermatitis, is a chronic inflammatory skin disorder characterised by red, dry skin and itching that can have a big impact on the lives of affected patients and their families. Children with eczema may have a constant urge to itch, leading to sleep disruption, and thus poor neurocognitive development, which also affects the children’s parents. Approximately 19% or more of children under 6 years are diagnosed with eczema. Additionally, 85–90% of people with eczema have the onset of the disease during the first 5 years of life. Mild symptoms are experienced by one-half to two-thirds of young children and this can be managed by the use of steroid ointments and moisturisers; however, one-third or more of children have moderate-to-severe eczema, which requires a more aggressive approach.
Immune-suppressing medications, such as oral steroids, have been used to treat severe eczema; however, clinicians tend to avoid giving this medication to children. Dupilumab, a medication that targets a key immune pathway in allergies, is the first ‘biologic’ drug and as a result of this study it and is now available for children as young as 6 years old. The trial involved a 16-week course of dupilumab or a placebo injection every 4 weeks throughout the course of the study, with the dosing being weight based. The inclusion criteria only included children who were not adequately responding to topical medication and with severe eczema despite the use of topical medication. This resulted in a 75% reduction of signs and symptoms of eczema as well as remarkable reduction in itching, leading to improved sleep, in more than half of the children.
“The ability to take this drug will significantly improve the quality of life for infants and young children who suffer tremendously with this disease,” said Amy Paller, Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children’s Hospital, Chicago, Illinois, USA.