Dupilumab Significantly Reduces Signs, Symptoms of Moderate-to-Severe Atopic Dermatitis in Children 6 Months and Older
Improvements in moderate-to-severe atopic dermatitis began quickly after the first dose of dupilumab, with improved itching in 1 week and skin clearance in 2 weeks.
A clinical trial of dupilumab (Dupixent; Regeneron and Sanofi) has found significant improvement in the signs and symptoms of moderate-to-severe atopic dermatitis among children as young as 6 months of age, according to a press release.
These findings make dupilumab the first biologic medication to show positive results in this young patient population, according to the researchers. It is the only approved biologic in patients 6 years of age and older with uncontrolled moderate-to-severe atopic dermatitis.
Atopic dermatitis is a chronic type 2 inflammatory skin disease, and between 85% and 90% of patients experience disease onset before age 5. Symptoms often continue through adulthood and include intense, persistent itch, and skin lesions that result in skin dryness, cracking, redness or darkening, and crusting, along with an increased risk of skin infections.
“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, MD, PhD, in the press release. “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.”
The trial met all primary and secondary endpoints, demonstrating that its addition to standard-of-care topical corticosteroids significantly reduced overall disease severity and improved skin clearance, itch, and health-related quality of life measures. These improvements began quickly after the first dose, with improved itching in 1 week and skin clearance in 2 weeks.
According to the press release, the data reinforce the established safety and efficacy profile of dupilumab in other age groups, including findings for a lower observed rate of skin infection in patients receiving the drug. During the 16-week treatment period, patients receiving dupilumab were 50% less likely to experience a skin infection and the total number of infections was nearly 70% lower.
“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,” Yancopoulos said in the press release. “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.”
Trial participants received dupilumab or placebo every 4 weeks in addition to topical corticosteroids. According to the press release, 28% of patients receiving dupilumab achieved clear or almost-clear skin compared to 4% of patients receiving the placebo. Furthermore, 53% of patients in the dupilumab arm achieved 75% or greater overall disease improvement from baseline compared to 11% with placebo.
The researchers also found a 70% average improvement from baseline in overall disease severity compared with a 20% improvement in the placebo arm, and a 49% average improvement in itching compared to a 2% improvement in the placebo arm. Finally, dupilumab significantly improved measures of observed patient outcomes, including sleep, skin pain, and health-related quality of life, as well as caregiver-reported health-related qualities of life.
“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,” said John Reed, MD, PhD, global head of research and development at Sanofi, in the press release. “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 very young patients.”
Dupixent (dupilumab) pivotal trial meets all primary and secondary endpoints becoming first biologic medicine to significantly reduce signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months. Regenerson; August 30, 2021. Accessed September 7, 2021. https://newsroom.regeneron.com/index.php/news-releases/news-release-details/dupixentr-dupilumab-pivotal-trial-meets-all-primary-and