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Phase 3 open-label extension data suggest young patients may even improve skin clearance scores after a year on the biologic therapy.
Monoclonal antibody dupilumab (Dupixent) was associated with sustained symptomatic improvement from atopic dermatitis among pediatric patients treated for up to 52 weeks.
In new data from the phase 3, open-label extension LIBERTY AD PED-OLE trial, presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience this weekend, the Sanofi- and Regeneron-sponsored research showed patients aged ≥6 to <12 years old with moderate to severe atopic dermatitis showed sustained improvement in metrics of disease management such as Investigators Global Assessment (IGA) and Eczema Area Severity Index (EASI) scoring up to 1 year of care with the biologic.
The new findings come nearly 1 year after dupilumab was approved by the US Food and Drug Administration (FDA) for the add-on treatment of moderate to severe, uncontrolled atopic dermatitis in children aged 6-11 years old.
Led by Michael J. Cork, MD, of Sheffield Dermatology Research at the University of Sheffield in the UK, investigators sought to observe ongoing, long-term efficacy and safety outcomes among LIBERTY AD PED-OLE trial participants receiving dupilumab. As they noted, long-term pediatric atopic dermatitis therapy options are currently limited.
Cork and colleagues enrolled patients from the previous LIBERTY PEDS trial for the open-label extension. The children and adolescent participants received 300mg dupilumab every 4 weeks, with the option of an up-titration in the event of inadequate clinical response by week 16. The new assessment includes 362 patients at the extension baseline, 309 patients observed through week 4, and 34 patients observed at week 52.
Mean patient age was 8.6 years old at baseline, with 48.6% reported as male and 72.7% identified as White. Mean duration of atopic dermatitis in each patient was 7.4 years.
At baseline, 18% of patients reported IGA scores of 0-1. The rate improved to 24.6% at week 4, then 44.1% at week 52.
Mean percent change in EASI score from the parent trial baseline to open-label extension baseline was -59.4%. Scores continually improved by week 4 (-71.1%) and week 52 (-85.7%).
Reduction of ≥75% in EASI (EASI 75) was achieved by 41.2% of patients at open-label extension baseline relative to parent trial baseline EASI scores. By week 4, the rate of EASI 75 improved to 54.4% of patients, then to 79.4% at week 52.
Treatment emergent events were reported in a majority of observed open-label patients (58.8%), though just 2.5% experienced a serious event. The most commonly reported events among patients included exacerbations (15.5%) and nasopharyngitis (13.0%).
Cork and colleagues concluded the findings support the known benefits and safety of dupilumab in moderate to severe atopic dermatitis among pediatric patients treated through a year.
“Long-term treatment with dupilumab showed sustained improvement in signs of AD in the cohort of patients who completed up to 52 weeks,” they wrote. “Data were consistent with the known dupilumab safety profile.”
The study, "Long-Term Efficacy and Safety Data for Dupilumab in a Phase 3, Open-Label Extension Trial (LIBERTY AD PED-OLE) in Patients Aged =6 to <12 Years With Uncontrolled, Moderate-to-Severe Atopic Dermatitis (AD),” was presented at AAD VMX.