TARRYTOWN, N.Y. and PARIS, Aug. 30, 2021 /PRNewswire/ --
Dupixent rapidly improved symptoms after first dose, improving itch in one week and skin clearance in two weeks
More than seven times as many patients treated with Dupixent plus topical corticosteroids (TCS) achieved clear or almost clear skin compared to TCS alone at week 16
Dupixent plus TCS reduced overall disease severity by 70% and itch by 49%
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive pivotal Phase 3 results from a trial evaluating Dupixent® (dupilumab) to treat moderate-to-severe atopic dermatitis in children aged 6 months to 5 years. The trial met its primary and all secondary endpoints, showing that Dupixent added to standard-of-care topical corticosteroids (TCS) significantly reduced overall disease severity and improved skin clearance, itch and health-related quality of life measures at 16 weeks compared to TCS alone (placebo). Dupixent is the first biologic medicine to show positive results in this young population and remains the only approved biologic medicine in patients 6 years and older with uncontrolled moderate-to-severe atopic dermatitis.
The data reinforce the well-established efficacy and safety profile of Dupixent in other age groups, including a lower observed rate of skin infections in the Dupixent group compared to placebo. During the 16-week treatment period, Dupixent patients were 50% less likely to experience a skin infection (12% Dupixent, 24% placebo), and the total number of infections was nearly 70% lower (11 Dupixent, 34 placebo). These results add to the extensive LIBERTY AD clinical program – the largest Phase 3 clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents and adults to date.
"Moderate-to-severe atopic dermatitis in infants and young children is incredibly distressing for patients and their caregivers, who manage painful and persistent itch, intensive daily skincare routines such as chlorine baths and wet wraps, as well as sleepless nights for children and their families," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "In fact, when starting this trial, the disease covered more than half of children's bodies and nearly a third of patients had previously resorted to using immunosuppressive medicines. These data show that Dupixent dramatically reduced the impact of atopic dermatitis on the lives of these young children and their families, with rapidly cleared skin, improved itch and improved observed patient outcomes, including sleep and skin pain. Importantly, Dupixent provided its benefits without acting as a broad immunosuppressant. In fact, Dupixent-treated patients experienced nearly 70% fewer skin infections compared to placebo patients."
Atopic dermatitis is a chronic type 2 inflammatory skin disease, with the age of onset younger than 5 years in 85 to 90% of patients. The debilitating symptoms that infants and young children with moderate-to-severe atopic dermatitis experience often continue through adulthood and include intense, persistent itch and skin lesions that can cover much of the body, resulting in skin dryness, cracking, redness or darkening, and crusting and oozing, along with increased risk of skin infections. Moderate-to-severe atopic dermatitis significantly impacts the life of a young child, their parents and caregivers, including their mood, sleep patterns, and quality of life. In addition, the underlying type 2 inflammation involved in atopic dermatitis can contribute to the development of other atopic diseases, like asthma and certain allergies, that may also appear throughout a person's life.
"When a child is diagnosed with moderate-to-severe atopic dermatitis in the first few months of life, many aspects of their childhood can be significantly impacted. Parents and caregivers are challenged to find safe and effective treatment options," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "Currently, the standard of care for this patient population is topical steroids and other immunosuppressive medicines may be used which can damage delicate skin and, if used long-term, potentially impact growth. Knowing that safety is of the utmost importance for physicians and parents when considering treatment options for children and infants, we are encouraged by the results of this trial showing Dupixent addressed the signs and symptoms of atopic dermatitis without broadly suppressing the immune system, demonstrating the potential it could have for these very young patients."
Patients received Dupixent every four weeks (200 mg or 300 mg, based on body weight) plus TCS or placebo. The primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75). The pre-specified primary analysis showed that at 16 weeks, among patients treated with Dupixent:
- 28% achieved clear or almost-clear skin compared to 4% with placebo (p