89 - The Impact of Moderate-to-Severe Atopic Dermatitis in Children Aged Less Than 12 Years in North America: An Analysis of the Real-World PEDISTAD Study

Sunday, April 30, 2023

3:30 PM – 6:00 PM ET

Poster Number: 89
Publication Number: 89.305

Scott T. Guenthner, Optima Dermatology / The Dermatology Center of Indiana / The Indiana Clinical Trials Center, Plainfield, IN, United States; Cory J. Rubin, Michigan Dermatology Institute, WATERFORD, MI, United States; Danielle Marcoux, Sainte-Justine University Medical Center, University of Montreal, mONTREAL, PQ, Canada; Michele L. Ramien, Alberta Children's Hospital, Calgary, AB, Canada; Charles W. Lynde, University of Toronto, Markham, ON, Canada; lara wine lee, Medical University of South Carolina College of Medicine, charleston, SC, United States; Joel C.. Joyce, NorthShore University HealthSystem, Skokie, IL, United States; Rajan Gupta, California University of Science and Medicine-School of Medicine, Houston, TX, United States; Ryan B. Thomas, Regeneron Pharmaceuticals, Inc., Montclair, NJ, United States; Annie Zhang, Sanofi, Cambridge, MA, United States

Presenting Author(s)

AZ

Annie Zhang, MD, MPH (she/her/hers)

Global Sr Medical Director
Sanofi
Cambridge, Massachusetts, United States

Background: Real-world data on disease characteristics and quality of life (QoL) impact in children with moderate-to-severe atopic dermatitis (AD) and their families are lacking.

Objective: To describe real-world disease characteristics and patient (pt) and family burden for pts aged < 12 years with moderate-to-severe AD enrolled into the PEDISTAD Study in Atopic Dermatitis (PEDISTAD) in North America.

Design/Methods:

PEDISTAD (NCT03687359) is an ongoing, international, 5-year, observational registry in 20 countries in pts aged < 12 years with moderate-to-severe AD inadequately controlled with topical therapies or for whom such therapies are inadvisable. We report data from 46 centers in North America. Baseline (BL) measures include Eczema Area and Severity Index (EASI; scale 0–72), AD-affected body surface area (BSA; 0–100%), Patient-Oriented Eczema Measure (POEM; 0–28), worst scratching during the previous 24 hours (age < 6 years; 0–10) or worst itching during the previous night and current day (age ≥6 years; 0–10), Infant’s Dermatitis Quality of Life Index (IDQOL; age < 4 years; 0–30) or Children’s Dermatology Life Quality Index (CDLQI; age ≥4 years; 0–30), and Dermatitis Family Impact (DFI; 0–30).

Results:

452 children were enrolled (52.9% male; mean age 5.8±3.3 years; 57.4% White, 22.9% Black/African American, 13.6% Asian). Atopic comorbidities affected 58.6% of children, most commonly food allergy (35.4%), asthma (29.4%), and allergic rhinitis (28.3%). 16.4% received systemic AD treatments (methotrexate [7.1%], dupilumab [6.0%], cyclosporine [2.4%], systemic corticosteroids [2.4%], and mycophenolate mofetil [0.7%]). BL disease severity and QoL measures (mean±SD) were: EASI 14.7±10.3 (i.e. moderate); BSA affected 32.5±21.0%; POEM 14.2±7.2 (i.e. moderate); worst scratching during the previous 24 hours 5.6±2.7; worst itching during the previous night 4.9±2.7; worst itching during the current day 4.0±2.6; IDQOL 9.9±5.9; CDLQI 10.4±6.5 (i.e. moderate); and DFI 9.6±7.0 (i.e. low impact). POEM responses for frequency of itching due to AD in the last week showed that 57.8% were impacted on 7/7 days and 7.7% for 5–6/7 days; for sleep disturbed by AD, 27.1% were impacted on 7/7 days and 11.2% for 5–6/7 days.

Conclusion(s): BL characteristics of children enrolled in PEDISTAD in North America reflect a multidimensional disease burden measured by atopic comorbidities, clinical signs including itch, sleep impact, QoL and family impact. This suggest that there is an unmet need in pediatric pts with moderate-to-severe AD for effective therapies with an acceptable safety profile.