77 - Systemic Treatments Outcomes for Moderate-to-Severe Atopic Dermatitis in Children Aged Less Than 12 Years: PEDISTAD 5-Year Results

Publication Number: 2073.77

Amy S. Paller, Northwestern University The Feinberg School of Medicine, Wilmette, IL, United States; Alan D. Irvine, School of Medicine, Trinity College Dublin, Dublin, Dublin, Ireland; Lawrence F.. Eichenfield, University of California, San Diego and Rady Children’s Hospital, San Diego, San Diego, CA, United States; Lin Ma, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, beijing, Beijing, China (People's Republic); Lara Wine Lee, Medical University of South Carolina, Charleston, SC, United States; Joel C. Joyce, Endeavor Health, Chicago, IL, United States; Marlies de Graaf, UMC Utrecht, Utrecht, Utrecht, Netherlands; Mercedes E. E. Gonzalez, Pediatric Skin Research, LLC, Miami, FL, United States; Rajan Gupta, TechData Service Company, Houston, TX, United States; Adriana Mello, Sanofi, Cambridge, MA, United States; Marius Ardeleanu, Regeneron Pharmaceuticals Inc., Tarrytown, NY, United States; Annie Zhang, Sanofi, Cambridge, MA, United States

Background: Real-world studies offer valuable insights into long-term effectiveness and safety of systemic therapies in pediatric patients with AD.

Objective: The objective of this study is to report the long-term effects of systemic therapies on clinician-reported outcomes in children aged < 12 years with moderate-to-severe AD enrolled in the PEDISTAD study.

Design/Methods: PEDISTAD (NCT03687359) is an ongoing, international, observational 10-year registry for patients with moderate-to-severe AD aged < 12 years at enrolment, who were receiving/were candidates for systemic treatment. Endpoints included mean EASI total score and the percentage affected BSA for patients receiving dupilumab, methotrexate (MTX), and cyclosporine (CsA). The number of AEs and discontinuations was also evaluated. Data are presented as observed.

Results: In this 5 year (2019 – 2024) interim analysis, 360, 152 and 151 patients received dupilumab, MTX, and CsA, respectively. At first and last observation, the mean EASI (standard error [SE]) for dupilumab, MTX and CsA were 17.7 (0.8) and 4.4 (0.3); 16.8 (1.1) and 7.5 (0.8); 18.8 (1.0) and 14.3 (1.2), respectively. Mean percentage BSA (SE) at first and last observation for dupilumab, MTX, and CsA were 35.0 (1.4) and 12.1 (0.9); 34.0 (1.8) and 17.3 (1.8); 39.6 (1.9) and 31.8 (2.4), respectively. The percentage of patients reporting AEs and serious AEs treated with dupilumab, MTX, and CsA were 28.8% and 1.4%; 28.6% and 0.6%; 31.4% and 2.0%, respectively. For dupilumab, MTX, and CsA, the cumulative discontinuation rates were 31.6%, 71.1%, and 88.7%, respectively; and the mean (SD) treatment exposure was 21.3 (17.4), 20.2 (16.9) and 13.6 (13.2) months, respectively. Safety was consistent with the known dupilumab safety profile.

Conclusion(s): Patients aged < 12 years treated with dupilumab had a numerically greater improvement in clinician-reported AD signs and lower discontinuation rates compared with MTX and CsA.