The Phase III trial for Sanofi/Regeneron’s Dupixent (dupilumab) plus topical corticosteroids (TCS) for the treatment of moderate-to-severe atopic dermatitis (eczema) in children aged six months to five years met its primary and secondary endpoints.

Data from the LIBERTY AD PRESCHOOL trial showed that Dupixent plus 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.

Dupixent is the first biologic medicine to show positive results in this young population and remains the only approved biologic medicine in patients six years and older with uncontrolled moderate-to-severe atopic dermatitis.

Dupixent patients were 50% less likely to experience a skin infection and the total number of infections was nearly 70% lower.

The standard of care for this patient population is topical steroids and other immunosuppressive medicines which can damage delicate skin and potentially impact growth if used long-term.

“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, president and chief scientific officer at Regeneron.

“When starting this trial, the disease covered more than half of children’s bodies and nearly a third had previously resorted to using immunosuppressive medicines… Dupixent-treated patients experienced nearly 70% fewer skin infections compared to placebo patients,” he added.