LIBERTY AD PRESCHOOL

Design and population. LIBERTY AD PRESCHOOL part B (Paller et al., Lancet 2022) was a randomised, double-blind, placebo-controlled, phase 3 trial at 31 hospitals and clinics in Europe and North America. Between 2020 and 2021 it randomised 162 children aged 6 months to under 6 years with moderate-to-severe Atopic Dermatitis (IGA 3–4) that Topical Corticosteroids had not controlled: 83 to Dupilumab and 79 to placebo. It is the only placebo-controlled trial of a biologic specifically in the toddler and preschool age group, and was funded by the manufacturers, Sanofi and Regeneron. LIBERTY AD PRESCHOOL [supports] Dupilumab

Intervention and primary outcome. Children received subcutaneous dupilumab every 4 weeks by weight (200 mg for 5–<15 kg; 300 mg for 15–<30 kg) or placebo, for 16 weeks. All also used low-potency Hydrocortisone acetate 1% cream. The primary endpoint was clear or almost-clear skin (IGA 0–1) at week 16; EASI-75 was the key secondary endpoint (co-primary in the EU). Hydrocortisone [part-of] LIBERTY AD PRESCHOOL EASI [defines] LIBERTY AD PRESCHOOL

Result. At week 16, 28% on dupilumab vs 4% on placebo had IGA 0–1 (difference 24%, 95% CI 13–34), and 53% vs 11% reached EASI-75 (difference 42%, 29–55; both p<0.0001). Overall adverse events were similar (64% vs 74%). Conjunctivitis affected 5% on dupilumab and none on placebo, and no dupilumab-related event was serious or led to stopping. In the open-label extension, 121 children with severe AD were followed for up to 2 years (50 reached week 104): 96% had EASI-75 and 92% clear-to-mild disease, but only 27% were clear or almost clear, and conjunctivitis affected 19% (Paller, Pediatric Drugs 2026). LIBERTY AD PRESCHOOL [relates] Conjunctivitis

Limitations. The randomised phase lasted only 16 weeks, so long-term safety and any effect on the Atopic March in toddlers rely on uncontrolled, sponsor-funded extension data. Fewer than a third reached clear or almost-clear skin. The trial does not compare dupilumab with Systemic Immunosuppressants or with optimised topical care such as Wet Wrap Therapy. LIBERTY AD PRESCHOOL [relates] Systemic Immunosuppressants

What it means for toddlers. This trial is why dupilumab is licensed from 6 months (US 2022 for moderate-to-severe; EU for severe AD only). For a 1–4-year-old whose eczema stays moderate-to-severe despite well-used emollients and topical steroids, it offers a specialist-prescribed, 4-weekly injection with no routine blood monitoring. Most children improve substantially, but complete clearance is the minority outcome, and eye symptoms should be watched for. It is a high-cost hospital medicine in the UK, not a first-line treatment. LIBERTY AD PRESCHOOL [relates] Treatment Outcomes Comparison

Connections

• Dupilumab — pivotal trial supporting under-6 licensing, source: Paller Lancet 2022
• Hydrocortisone — background 1% hydrocortisone acetate in both arms, source: Paller 2022
• Conjunctivitis — 5% vs 0% at 16 weeks; 19% over 2 years open-label, source: Paller 2022; 2026
• EASI — EASI-75 53% vs 11%, source: Paller 2022
• Treatment Outcomes Comparison — Track B advanced-therapy outcome data, source: Paller 2022