33553 Real-world treatment patterns and outcomes up to 1 year among children aged <12 years with moderate-to-severe atopic dermatitis (AD) enrolled in the PEDIatric STudy in Atopic Dermatitis (PEDISTAD) observational study

Background: We describe real-world treatment patterns in patients aged <12 years with moderate-to-severe AD, focusing on systemic treatments. Methods: PEDISTAD (NCT03687359) is an ongoing, international, noninterventional registry in patients aged <12 years with moderate-to-severe AD inadequately controlled with topical therapies. Treatment was per investigator discretion. In this interim analysis (data cutoff 30 July 2020), we report baseline data for all patients, and changes in the following outcomes (from therapy start [TS] to last observation [LO]) for patients receiving systemic treatments of interest (dupilumab, cyclosporine, or methotrexate): Eczema Area and Severity Index (EASI), AD-affected body surface area (BSA), Patient-Oriented Eczema Measure (POEM), Children’s Dermatology Life Quality Index (CDLQI; 4–<12 years), and current-day peak pruritus numerical rating scale (PP-NRS). No formal statistical testing was performed. Results: At baseline, 77.2% (565/732) of patients were receiving nonsystemic AD therapies (topical corticosteroids: 69.9%); 23.1% were receiving systemic therapies, including: dupilumab: 2.6% [n = 19]; cyclosporine: 8.1% [n = 59]; and methotrexate: 9.0% [n = 66]. The median duration of patient follow-up was 8.7 months. Physician-reported outcomes (change in mean ± SD) improved from TS to LO: EASI (dupilumab [n = 31], cyclosporine [n = 80], methotrexate [n = 69]: -13.8 ± 15.4, -4.6 ± 12.2, -6.2 ± 12.8) and % BSA (-18.4 ± 25.0, -13.6 ± 22.3, -14.6 ± 18.8). Change in patient/caregiver-reported outcomes were: POEM (-7.6 ± 8.5, -2.1 ± 11.1, -4.3 ± 11.2), CDLQI (-7.2 ± 7.8, 0.3 ± 5.5, -2.9 ± 6.8) and PP-NRS (-2.6 ± 2.3, 0.7 ± 3.0, 0.6 ± 2.5). Time-to-discontinuation (mean ± SD, months) was: dupilumab (8.6 ± 6.4); cyclosporine (5.2 ± 4.1); methotrexate (7.0 ± 4.7). Conclusions: The most common treatment at baseline for children aged <12 years with moderate-to-severe AD was topical corticosteroids. Dupilumab was associated with greater improvements in clinical assessments/patient-reported outcomes vs other systemic therapies.