Positive Phase 3 results show adding Dupixent (dupilumab) to standard-of-care topical corticosteroids (TCS) significantly improved skin clearance and reduced overall disease severity and itch in infants and children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis.
These data will be presented Monday in a late-breaking session at the 2021 Revolutionizing Atopic Dermatitis Conference (RAD 2021), the company said in a press release
“One of most challenging aspects of my job as a physician is having limited treatment options to help babies and young children suffering from moderate-to-severe atopic dermatitis, which can disrupt their ability to fully thrive in these early years of life ,” says Amy S. Paller, M.D, Walter J. Hamlin Professor and Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine, and principal investigator of the trial. “These results show dupilumabcan significantly improve the signs and overall severity of atopic dermatitis in children as young as 6 months. Safety is of paramount importance when treating children at such a young age.”
Eighty-five to 90% of patients with atopic dermatitis develop symptoms before the age of 5, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body (58% on average for the patients in this trial at baseline), resulting in skin dryness, cracking, redness or darkening, and crusting and oozing, along with the increased risk of skin infections. Moderate-to-severe atopic dermatitis may also significantly impact the quality of life of young children, their parents, and caregivers. In addition, the underlying type 2 inflammation involved in atopic dermatitis can contribute to the development of other diseases like asthma and certain allergies, that may also appear throughout a person’s life.
Topline results from the randomized, placebo-controlled pivotal trial, which met all primary and secondary endpoints,