15 Jun Biologic Dupixent® Approved for Children with Severe Atopic Dermatitis – Eczema
MedicalResearch.com Interview with:
Amy S Paller, MD
Chair, Department of Dermatology
Director, Skin Biology and Diseases Resource-Based Center
Walter J. Hamlin Professor of Dermatology
Professor of Dermatology and Pediatrics (Dermatology)
Feinberg School of Medicine
Dr. Paller discusses the FDA approval of Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis (eczema), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
MedicalResearch.com: What is the background for this announcement? Would you briefly discuss what is meant by atopic dermatitis and how it affects children?
Response: “Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that often appears as a rash on the skin. Moderate-to-severe atopic dermatitis is characterized by rashes that can potentially cover much of the body and can include intense, persistent itching, skin lesions and skin dryness, cracking, redness or darkness, crusting and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating.
This recent FDA approval expands the use of Dupilumab in the U.S. to include children aged 6 to 11 years with uncontrolled moderate-to-severe atopic dermatitis, making it the only biologic medicine approved for this use in this population. Dupilumab is also approved in the U.S. to treat patients aged 12 years and older with moderate-to-severe atopic dermatitis.
Moderate-to-severe atopic dermatitis can place a particularly substantial burden on young children aged 6 to 11 years and their families. Limited treatment options leave many of these children to cope with intense, unrelenting itch and skin lesions. Families of these children can spend countless hours helping them to manage their disease.”
MedicalResearch.com: What are the main findings of the underlying studies? How does Dupilumab differ from other eczema therapeutics?
Response: “Dupilumab is a biologic therapy that works differently from existing therapies to address type 2 inflammation – an underlying cause of atopic dermatitis. Dupilumab is the only biologic approved for this pediatric population.
In the pivotal trial, more than twice as many children achieved clear or almost clear skin and more than four times achieved itch reduction with Dupilumab plus topical corticosteroids (TCS) compared to TCS alone. Three-quarters of patients receiving Dupilumab achieved at least a 75% improvement in overall disease, with an average improvement of approximately 80%. Safety was consistent with the established safety profile of Dupilumab across adult and adolescent atopic dermatitis patients.”
MedicalResearch.com: How is Dupilumab administered?
Response: “Dupilumab comes in two doses based on weight, as a pre-filled syringe for pediatric patients aged 6 to 11 years. Dupilumab can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupilumab should be administered by a caregiver.”
Disclosures: “I was an investigator on this study without compensation but have also been a consultant with honorarium for Regeneron, which makes dupilumab. I will be presenting data highlighting dupilumab for pediatric patients at the virtual American Academy of Dermatology meeting, being held June 12-14, 2020”
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