76 - Disease and Family Burden of Moderate-to-Severe Atopic Dermatitis in Children Aged Less Than 6 Years: Results from the PEDISTAD Registry

Publication Number: 2072.76

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; Emma Guttman-Yassky, Icahn School of Medicine at Mount Sinai Medical Center, New York, NY, United States; Marlies de Graaf, UMC Utrecht, Utrecht, Utrecht, Netherlands; Eulalia Baselga, Hospital Sant Joan de Déu, Barcelona, Catalonia, Spain; Michele Ramien, University of Calgary, Calgary, AB, Canada; Tatsuki Fukuie, National Center for Child Health and Development, Tokyo, Tokyo, Japan; Lin Ma, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, beijing, Beijing, China (People's Republic); Rajan Gupta, TechData Service Company, Houston, TX, United States; Marius Ardeleanu, Regeneron Pharmaceuticals Inc., Tarrytown, NY, United States; Annie Zhang, Sanofi, Cambridge, MA, United States

Background: Investigating the real-world disease burden of atopic dermatitis (AD) in patients with moderate-to-severe AD and the impact on their families is crucial for identifying if AD is being effectively treated, especially in young children.

Objective: This analysis aims to report the real-world disease burden of AD in children aged < 6 years enrolled in the PEDISTAD registry.

Design/Methods: PEDISTAD (NCT03687359) is an ongoing, global, 10-year, observational registry that enrolled children aged < 12 years with moderate-to-severe AD. This interim analysis reports the baseline disease burden of children aged < 6 years with moderate-to-severe AD at enrollment who received systemic treatment for AD, or who received topical treatment (but were otherwise candidates for systemic treatments due to lack of efficacy or safety concerns with long-term topical treatment). Baseline comorbidities, AD treatments, Eczema Area and Severity Index (EASI; range 0–72), AD-affected body surface area (BSA; 0–100%), Patient-Oriented Eczema Measure (POEM; 0–28), Infants’ Dermatitis Quality of Life (IDQoL) Index (≤3 years; 0–30), Children’s Dermatology Life Quality Index (CDLQI; 4– < 12 years; 0–30), Dermatitis Family Impact (DFI) score (0–30), and Worst Scratching Numeric Rating Scale (WS NRS) score (0–10) are reported.

Results: A total of 883 patients (males, 56.2%; age [mean ± standard deviation (SD)], 2.9 ± 1.5) were aged < 6 years at enrollment in PEDISTAD, of which 50.1% had comorbidities, with the most frequent (incidence >10%) comorbidities being food allergies (35.6%), allergic rhinitis (19.9%), and asthma (13.1%). In total, 663 (75.0%) patients received non-systemic treatment, with most receiving topical corticosteroids (63.8%) or topical calcineurin inhibitors (25.6%). In total, 359 (40.7%) patients received systemic therapies, with most patients receiving antihistamines/antiallergics (24.8%), systemic corticosteroids (19.6%), or dupilumab (16.5%). At baseline, the mean ± SD clinician- and patient-reported outcome scores were as follows: EASI, 13.6 ± 11.0; BSA, 31.7 ± 21.4; POEM, 15.4 ± 7.4; IDQoL, 10.6 ± 6.3; CDLQI, 10.5 ± 6.4; DFI, 12.0 ± 7.7; and WS NRS, 5.9 ± 2.7.

Conclusion(s): The baseline characteristics of patients aged < 6 years enrolled in PEDISTAD show a multidimensional disease burden of uncontrolled moderate-to-severe AD despite the use of standard treatments in the real-world.