PowerPoint Presentation Understanding Flares in Pediatric and Adolescent Patients with Moderate or Severe Atopic Dermatitis: A Real-world Study in the United States and Europe Lawrence F Eichenfield1, Vivian Y Shi2, JiaDe Yu3,4, Evangeline J Pierce5, Amber Reck Atwater5, Jenny Austin6, Phoebe Salmon6, James Piercy6, Peter Anderson6, Amy S Paller7 1. Departments of Dermatology and Pediatrics, University of California San Diego School of Medicine and Rady Children’s Hospital San Diego; 2. Department of Dermatology, University of Arkansas for Medical Sciences; 3. Department of Dermatology Massachusetts General Hospital; 4. Harvard Medical School; 5. Eli Lilly and Company, Indianapolis, USA ; 6. Adelphi Real World, Bollington, UK; 7. Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, USA METHODS Study Design BACKGROUND / SYNOPSIS ■ Atopic dermatitis (AD) is a chronic heterogeneous inflammatory skin disorder characterised by pruritus and eczematous lesions ■ AD has a fluctuating disease pattern with many patients experiencing acute exacerbations often referred to as ‘flares’1.2 ■ Currently, real-world data on pediatric and adolescent (≤17 years) AD are limited, with the impact of the reported disease burden, including flares, largely unquantified OBJECTIVE ■ The objective of this study is to better understand flaring in patients <17 years old with moderate or severe AD CONCLUSIONS ■ Just over 60% of moderate and severe patients with AD, aged <17 years, experience flares, the large majority having experienced multiple flares during the past year. A typical flare for moderate or severe patients lasted two weeks ■ AD flares cause a moderate to high degree of bother in both moderate and severe patients although greater in patients with severe AD ■ These findings suggest that controlling flares could lead to a lower burden of disease Key Eligibility Criteria Physician inclusion criteria: – Primary Care Practitioners / Pediatricians / Dermatologists / Allergists – Actively involved in drug management of patients <17 years old with AD – Minimum monthly workload of • For PCPs / Pediatricians: – >4 AD patients, aged <17 years (≥1 ever mild, ≥1 mild with history of moderate/severe AD, ≥1 moderate) • For Dermatologist / Allergists / Immunologists: – >6 AD patients, aged <17 years (≥1 mild with history of moderate/severe AD, ≥3 moderate, ≥1 severe). Study was sponsored by Eli Lilly and Company Patient inclusion criteria (for this analysis): – <17 years old – Physician diagnosis of AD – Currently assessed to have moderate or severe AD – Not currently involved in a clinical trial. Additional Methods ■ Data were drawn from the Adelphi Pediatric AD Disease Specific Programme3, a retrospective cross-sectional real- world study conducted in the United States, France, Germany, Italy, Spain and the United Kingdom between February and June 2019 ■ Physicians provided information on clinical characteristics including current overall disease severity (physician determination of mild, moderate, or severe AD) as well as severity, number, and duration of flares ■ Flares were defined in the physician completed patient record forms as “acute episodes = flares, temporary worsening of symptoms” ■ Patients, or their parent/guardian, were invited to complete a patient self-completion questionnaire (PSC) reporting the degree of bother for “times when your skin gets much worse’” (extremely, very, moderately, a little, or not at all bothered by flares) ■ For this analysis “very/extremely” were defined as a high degree of bother and “a little/not at all” as low degree of bother Table 1. Patient Demographics and Clinical Characteristics Winter Clinical Dermatology Conference; Hawaii, USA; January 13-18, 2023 Scan or click the QR code or use this URL (https://lillyscience.lilly.com/congress/wcdc2023) for a list of all Lilly content presented at the congress. Other company and product names are trademarks of their respective owners. Moderate Patients (n=1005) Severe Patients (n=762) Demographics Mean Age, Years (SD) 9.9 (5.0) 11.2 (5.0) Male Gender, % 50.5 55.2 Mean BMI (SD), kg/m2 19.8 (6.3) 20.7 (8.6) Race: White, % 76.7 76.9 Clinical Characteristics Time Since Diagnosis, Years (SD) 3.4 (3.6) 4.3 (4.3) Those with Type II Comorbidity, % 46.8 60.2 BSA Currently, % 18.6 32.2 EASI (range 0-72) 9.2 20 RESULTS ■ A total of 390 physicians (49 PCPs; 90 Pediatricians; 210 Dermatologists; 41 Allergists) provided records for 2570 patients of whom 1005 were considered currently moderate and 762 currently severe (Table 1). 803 currently mild patients were excluded ■ 427 moderate and 304 severe patients or their parent/guardian completed a PSC ■ For 60.1% of moderate patients and 62.4% of severe patients, the physician reported the patient had suffered acute episodes (flares) as part of their disease pattern; 53.7% of moderate and 57.1% of severe patients experienced 1 or more flares during the last 12 months (Fig 1) ■ Of those with flares in the last 12 months, moderate patients suffered a median [interquartile range] of 2[2-3] flares and severe patients suffered a median of 3[2-4] (Fig 2) ■ Moderate patients were more likely to have mild or moderate flares (determined by physicians) while severe patients had more moderate and severe flares (Fig 2) ■ The median duration of a typical flare for both moderate and severe patients was 14 days (Fig 3) ■ 64.5% of severe patients self-reported the degree of bother of flares as high, 21.1% reported moderate bother and 14.5% reported low bother. For moderate patients, 38.6% reported a high degree of bother, 29.7% moderate bother and 31.6% low bother (Fig 4) Figure 4. Patient-reported degree of bother during times when their skin gets much worse KEY RESULTS Figure 1. Physician-reported flares among moderate and severe patients Figure 3. Physician-reported median [IQR] duration of flares (days) over the last 12 months IQR: Interquartile range REFERENCES 1. Girolomoni G and Busà VM. Ther Adv Chronic Dis. 2022; 13:1-19 2. Sidbury R et al. J Am Acad Dermatol. 2014; 71(6): 1218–1233. 3. Anderson P et al. Curr Med Res Opin. 2008;24(11):3063-7 DISCLOSURES  LE, VS, and AP are in receipt of consultancy payments with Eli Lilly and Company  EP and ARA are employees of Eli Lilly and Company  JA, PS, JP and PA are employees of Adelphi Real World  The DSP is a wholly owned Adelphi Real World multi-subscriber product. Eli Lilly and Company is one of a number subscribers to the DSP.  This study is previously presented at Fall Clinical Dermatology Conference (Fall CDC 2022); Hybrid / Las Vegas, USA; 20-23 October 2022 Type II Comorbidity: Allergic Contact Dermatitis, Allergic Rhinitis, Alopecia Areata, Angioedema, Atopic Keratoconjunctivitis, Asthma, Nasal Polyps, Other Allergic Conditions, Urticaria, Vitiligo Figure 2. Physician-reported median [IQR] number of flares over the last 12 months IQR: Interquartile range Slide Number 1