562 - Dupilumab Treatment Provides Sustained Improvement in Skin Barrier Function, Clinical Outcomes, and Patient-Reported Outcomes in Patients Aged 6 to 11 Years With Moderate-to-Severe Atopic Dermatitis
Global Sr Medical Director Sanofi Cambridge, Massachusetts, United States
Background: Skin barrier dysfunction is an important feature of atopic dermatitis (AD), a common, itchy inflammatory skin disease, that can have a high impact on quality of life of both affected children and their families. Objective: To report the impact of dupilumab on skin barrier function, clinical outcomes, and patient-reported outcomes (PROs) in patients aged 6–11 years with moderate-to-severe AD. Design/Methods: In PELISTAD (NCT04718870), patients aged 6–11 years were treated with dupilumab for 16 weeks (12-week follow-up) by baseline weight (≥15kg– < 30kg: 300mg q4w; ≥30kg– < 60kg: 200mg q2w) and matched with healthy volunteers. Transepidermal water loss (TEWL) was longitudinally assessed in lesional and non-lesional skin of patients with AD and in healthy skin. Eczema Area and Severity Index (EASI) and Worst Itch Numerical Rating Scale (WI-NRS) were also assessed. Results: At baseline, median basal TEWL (95%CI) in lesional (48.2 [32.0–64.3]) and non-lesional AD skin (25.3 [15.8–34.8]) was significantly higher than in healthy skin (13.5 [8.2–18.8]; P< 0.0001 and P< 0.001, respectively). Significant improvement in median TEWL was observed in lesional skin after 16 weeks of dupilumab treatment (28.1 [21.4–34.8]; P< 0.0001, vs baseline), which persisted to Week (W)28 in lesional (20.9 [9.3–32.6]) and non-lesional skin (16.0 [12.1–19.9]; P< 0.01, vs baseline). Mean EASI (SD) decreased from 34.8 (11.9) at baseline to 11.3 (11.0) at W16, and to 6.5 (5.1) at W28. WI-NRS decreased from 7.6 (2.1) at baseline to 3.0 (1.4) at W16, and to 2.0 (2.2) at W28. Safety was consistent with the known dupilumab safety profile.
Conclusion(s): Dupilumab treatment improved skin barrier function, clinical outcomes, and PROs in patients aged 6–11 years with moderate-to-severe AD; these improvements persisted for three months beyond the end of treatment.
