Dupixent significantly improved skin clearance and reduced overall disease severity and itch in pivotal trial that met all primary and secondary endpoints
Global regulatory filings planned in the coming months, starting
Dupixent significantly improved skin clearance and reduced overall disease severity and itch in pivotal trial that met all primary and secondary endpoints
Global regulatory filings planned in the coming months, starting with the U.S. by the end of 2021
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced detailed positive Phase 3 results that showed 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 today in a late-breaking session at the 2021 Revolutionizing Atopic Dermatitis Conference (RAD 2021).
"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," said 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 dupilumab can 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. We are encouraged that these data show a safety profile consistent with what has been seen in other age groups. We will continue to follow these patients for up to 5 years in an open-label trial."
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 increased risk of skin infections. Moderate-to-severe atopic dermatitis may also significantly impact the quality of life of a young child, 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, were announced in August 2021. Data presented at RAD 2021 showed that at 16 weeks, patients who added Dupixent to low-potency TCS experienced the following, compared to low-potency TCS alone (placebo):
- 28% achieved clear or almost-clear skin compared to 4% with placebo (p<0.0001), the primary endpoint.
- 70% average improvement from baseline in disease severity compared to 20% improvement with placebo (p<0.0001), a key secondary endpoint.
- 53% achieved 75% or greater improvement in overall disease severity from baseline compared to 11% with placebo (p<0.0001), the co-primary endpoint outside of the U.S.
- 49% average improvement from baseline in itch compared to 2% improvement with placebo (p<0.0001).
The safety profile observed in the randomized, placebo-controlled trial was consistent with the well-established safety profile of Dupixent in adults, adolescents and children 6 years and older with moderate-to-severe atopic dermatitis. Overall rates of adverse events (AEs) were 64% for Dupixent and 74% for placebo. Most common AEs and AEs of special interest included nasopharyngitis (8% Dupixent, 9% placebo), upper respiratory tract infection (6% Dupixent, 8% placebo), conjunctivitis (5% Dupixent, 0% placebo) and herpes viral infections (6% Dupixent, 5% placebo).
These results will form the basis of global regulatory submissions for this age group, beginning with the U.S. in 2021 and European Union in the first half of 2022.
Additionally, long-term data from the Phase 3 trial in patients aged 6 to 11 years with moderate-to-severe atopic dermatitis are also being presented in a late-breaking session. Efficacy and safety results at one year were consistent with the known profile of Dupixent in atopic dermatitis.
The data from these trials add to the extensive LIBERTY AD clinical program – the largest Phase 3 clinical trial program in atopic dermatitis, involving approximately 3,500 infants, children, adolescents and adults to date.
Dupixent is the first biologic medicine to demonstrate positive results in this young patient population. The efficacy and safety of Dupixent in children below the age of 6 years have not been fully evaluated by any regulatory authority.
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