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A trio of analyses from LIBERTY AD PEDS, LIBERTY AD PRESCHOOL, and the long-term PED-OLE extension study show dupilumab (Dupixent) improves growth attainment in school-age children, provides rapid caregiver-reported symptom relief in infants and toddlers, and sustains regional skin improvements across body regions for up to 3 years in children with atopic dermatitis (AD).1,2,3
Presented at the Revolutionizing Atopic Dermatitis (RAD) 2026 Conference, the analyses span the youngest patients in dupilumab's development program, from infants as young as 6 months through children aged 11 years, and document benefits ranging from improved height percentile gain to reduced caregiver burden during the first 2 weeks of treatment.
"Dupilumab treatment for up to 3 years demonstrated sustained efficacy across all anatomic regions in children aged 6 months to 11 years with moderate-to-severe AD, with safety consistent with the known safety profile of dupilumab," the PED-OLE investigators concluded.
In the LIBERTY AD PEDS growth analysis, children aged 6 to 11 years with severe AD who were below the 30th height percentile at baseline showed significantly greater height gain with dupilumab than placebo over 16 weeks. The proportion achieving at least a 5-percentile improvement in height-for-age was 31.9% with dupilumab versus 11.1% with placebo (P <.05).
Logistic regression models confirmed the growth benefit remained significant after adjustment for cumulative topical corticosteroid (TCS) dose (Odds Ratio, 4.21; 95% CI, 1.40-12.63; P = .010), indicating dupilumab's effect appears independent of reduced TCS use.
In LIBERTY AD PRESCHOOL, caregivers of infants and children aged 6 months to 5 years reported significantly better Caregiver Global Impression of Disease scores, indicating no or mild symptoms, with dupilumab versus placebo from week 2, the earliest timepoint measured. By week 16, 51.8% of caregivers in the dupilumab group reported no or mild symptoms versus 5.5% with placebo.
On the Caregiver Global Impression of Change, 67.1% of caregivers in the dupilumab group rated symptoms as much better or moderately better at week 16 versus 11.2% with placebo (P <.0001), a difference of 55.9 percentage points.
The PED-OLE open-label extension (NCT02612454) enrolled children from both LIBERTY AD PRESCHOOL (ages 6 months to 5 years; N=180) and LIBERTY AD PEDS (ages 6-11 years; N=383), providing up to 152 weeks of continuous dupilumab data. The analysis examined EASI-75 and EASI-90 by anatomic region: head, trunk, upper extremities, and lower extremities.
In children aged 6 months to 5 years at week 52, EASI-90 response rates were 91.9% for head/neck, 81.8% for trunk, 85.4% for upper extremities, and 77.7% for lower extremities. In the 6-11 year age group at week 152, EASI-90 rates were 80.9% for head, 77.7% for trunk, 86.4% for upper extremities, and 75.3% for lower extremities.
Treatment-emergent adverse events led to permanent discontinuation in 1.1% of the younger cohort and 0.8% of the older cohort. Drug-related serious treatment-emergent adverse events were infrequent (0.6% and 0.3%).
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