Regeneron, Sanofi Announce Positive Results for Dupilumab for Infants, Children

Regeneron Pharmaceuticals, Inc, and Sanofi have announced detailed positive phase 3 results showing that adding dupilumab (Dupixent) to standard-of-care topical corticosteroids (TCS) can significantly improve skin clearance and reduce itch and overall disease severity in infants and children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis (AD).

The findings were presented in a late-breaking session at the 2021 Revolutionizing Atopic Dermatitis Conference.

About 85% to 90% of individuals with AD develop symptoms before aged 5 years that can often continue into adulthood, according to a statement from Regeneron.

Symptoms can include intense and persistent itch, as well as skin lesions covering the body, about (58% of individuals, on average, in this sample) and can results in skin cracking, crusting, darkening, dryness, oozing, or redness, as well as an increased risk of skin infections.

"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,” Amy Paller, MD, chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine, said in a statement.

“We are encouraged that these data show a safety profile consistent with what has been seen in other age groups,” she said. “We will continue to follow these patients for up to 5 years in an open-label trial."

The topline results were from a placebo-controlled, randomized pivotal trial, which met all primary and secondary endpoints, which were announced in August 2021.

The data presented showed that at 16 weeks, 28% of individuals who added dupilumab to low-potency TCS achieved clear or almost-clear skin compared with 4% with the placebo, which was the primary endpoint.

Additionally, 70% of individuals had average improvement from the baseline in disease severity compared with 20% improvement with the placebo, which was a key secondary endpoint.

About 53% of individuals achieved 75% or greater improvement from the baseline compared with 11% with the placebo, which was the co-primary endpoint outside the United States.

About 49% of individuals averaged improvement from the baseline in itching compared with 2% improvement with the placebo.

The safety profile observed was consistent with the known safety profile of dupilumab in individuals aged 6 years or older with moderate-to-severe atopic dermatitis. Overall rates of adverse events (AEs) were 64% for dupilumab and 74% for the placebo.

The most common AEs were nasopharyngitis (8% for dupilumab and 9% for the placebo), upper respiratory tract infections (6% and 8%, respectively), conjunctivitis (5% and 0%, respectively), and herpes viral infection (6% and 5%, respectively).

These results will form the basis of global regulatory submissions for this age group, beginning in the United States in 2021 and the European Union in the first half of 2022.

Long-term data from the phase 3 trial for individuals aged 6 to 11 years with moderate-to-severe atopic dermatitis will also be presented. The efficacy and safety results at 1 year were consistent with the known profile of dupilumab for atopic dermatitis.

The data from these trials adds to the extensive LIBERTY AD clinical program, involving 3500 infants, children, adolescents, and adults to date.

Reference

Positive phase 3 Dupixent (dupilumab) data in children 6 months to 5 years with moderate-to-severe atopic dermatitis featured in RAD 2021 late-breaking session. Regeneron. News release. December 13, 2021. Accessed on December 13, 2021. https://investor.regeneron.com/news-releases/news-release-details/positive-phase-3-dupixentr-dupilumab-data-children-6-months-5