Systemic Treatment Outcomes in Children Aged Under 12 Years With Moderate-to-Severe Atopic Dermatitis: PEDISTAD Registry 6-Year Report

Introduction: Real-world studies can provide insight into the long-term effectiveness and safety of systemic therapies in pediatric patients with atopic dermatitis (AD). The objective of the study was to report the long-term effects of systemic therapies on Eczema Area and Severity Index (EASI) total score and percent body surface area (BSA) affected in children with moderate-to-severe AD. Method: PEDISTAD (NCT03687359), an ongoing, international, observational, 10-year registry, enrolled children aged <12 years who were receiving/were candidates for systemic treatment. This 6-year (2019–2025) interim analysis reports data collected at therapy start and last available observation, grouped by the treatment received — dupilumab, methotrexate, or cyclosporine. Data are presented as observed. Results: 1,072, 845, 649, 521, 256, and 17 children completed 1, 2, 3, 4, 5, and 6 years study visits, respectively. Of those 460, 151, and 155 children received dupilumab, methotrexate, and cyclosporine, respectively. The mean change from start of treatment to last available observation for EASI was −12.7 (baseline = 16.9; P < 0.0001), −8.1 (16.7; P < 0.0001), and −4.3 (18.3; P = 0.0008); BSA was −21.9% (baseline = 33.5%; P < 0.0001), −15.0% (33.7%; P < 0.0001), and −6.8% (38.3%; P = 0.0025) for dupilumab, methotrexate, and cyclosporine, respectively. Adverse events occurred in 31.1%, 31.8%, and 30.3% of children treated with dupilumab, methotrexate, and cyclosporine respectively. Discontinuation rates were 32.9% (dupilumab), 81.1% (methotrexate), and 92.9% (cyclosporine). Conclusions: Children aged <12 years with moderate-to-severe AD treated with dupilumab had a numerically greater improvement in clinician-reported AD disease assessments and observed lower discontinuation rates when compared to those treated with methotrexate and cyclosporine. Less than a third of all patients reported adverse events.