P036 Dupilumab treatment normalizes skin barrier function in children aged 6–11 years with moderate-to-severe atopic dermatitis

Abstract Atopic dermatitis (AD) is associated with significant disruption in skin barrier function, mediated by the type 2 inflammatory cytokines interleukin (IL)-4 and IL-13. This study reports the effect of dupilumab treatment in paediatric patients (aged 6–11 years) with moderate-to-severe AD on skin barrier function and clinician- and patient-reported outcomes. PELISTAD (NCT04718870) was an open-label, exploratory study on skin barrier function in children aged 6–11 years with moderate-to-severe AD treated with dupilumab for 16 weeks based on baseline patient weight (300 mg every 4 weeks: ≥ 15 kg to 30 kg; 200 mg every 2 weeks: ≥ 30 kg to 60 kg) and matched healthy volunteers. Transepidermal water loss (TEWL) was assessed longitudinally after skin tape stripping from lesional and nonlesional skin of patients with AD treated with dupilumab, and from healthy skin. Eczema Area and Severity Index (EASI) and skin pain numerical rating scale (NRS) were assessed during the same periods. Twenty-three dupilumab-treated patients and 18 healthy volunteers were included in the study. After 16 weeks of dupilumab treatment, median (95% confidence interval) TEWL after five skin tape strips significantly decreased in the lesional skin of patients with AD (33.8, 25.2–42.3) compared with baseline (63.7, 44.1–83.3; P 0.001). Least squares mean (standard error) TEWL after five skin tape strips in lesional skin (30.7, 3.5) was comparable with that observed in healthy skin (27.8, 4.4) at week 16 (P = 0.62). Similar improvement was observed in nonlesional skin (25.5, 2.1), which did not significantly differ from healthy skin (24.6, 2.6; P = 0.79). Mean (SD) EASI decreased from 34.8 (11.9) at baseline to 11.3 (11.0) at week 16. Improvement was also observed in skin pain NRS, which decreased from mean (SD) 6.8 (2.5) at baseline to 2.3 (1.4) at week 16. Overall safety was consistent with the known dupilumab safety profile. Dupilumab treatment normalizes skin barrier function and improves clinician- and patient-reported outcomes in paediatric patients aged 6–11 years with moderate-to-severe AD. This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov identifier: NCT04718870.