Lilly Immunology Impact Of Day-to-Day Sleep Disruption on The Burden of Disease In Moderate-severe Adult Atopic Dermatitis Patients Evangeline Pierce,1 C. Elise Kleyn,2 Susanne Grond,1 Jenny Austin,3 Catherine Reed,1 Sonja Ständer 4 1Eli Lilly and Company, Indianapolis, IN, USA; 2The Dermatology Centre, Salford Royal NHS Foundations Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, University of Manchester, Manchester, UK; 3Adelphi Real World, Bollington, UK; and 4University Hospital Münster, Münster, Germany METHODS Data Source  Data were drawn from the Adelphi Atopic Dermatitis Disease Specific Programme (DSPTM), a multi- national, point in time survey of physicians (dermatologists, allergists and PCPs) and their consulting AD patients in the US (during 2018), Germany (2019), Italy (2019), UK (2019), France (2020) and Spain (2021).  The study used data from adults aged ≥18 years with physician-assessed moderate-to-severe AD. Patient-Reported Outcomes  Patients completed PRO questionnaires in which they were asked to select ongoing day-to-day symptoms they usually experienced (not related to a flare) from a list including S-D, itch, skin pain, anxiety, and depression/low mood, and to rate the symptom frequency.  Two patient groups were evaluated: those with frequent S-D (all the time/regularly) and those with infrequent S-D (sometimes/rarely/none). Table 1. Physician-reported demographics and clinical characteristics for adults with moderate-to- severe AD according to the frequency of S-D. DISCLOSURES S Ständer has declared consulting fees from: Beiersdorf, Bellus Health, Benevolent, Bionorica, Clexio, Escient, Galderma, Grünenthal, Lilly, Menlo, Pfizer, Sanofi, Trevi, and Vifor, and honoria/speaker fees from: Abbvie, Almirall, Galderma, Grünenthal, Leo, Lilly, Menlo, Pfizer, Sanofi, Trevi, P.G. Unna Academy, and Vifor Plough, Abbott, Janssen and Creabilis. E Kleyn has declared honoraria/ad hoc consultancy payments from Janssen, Eli Lilly, LEO, Novartis, Abbvie, UCB and Almirall as well as research funding from Pfizer, Novartis, Janssen and Eli Lilly. J Austin is an employee of Adelphi Real World C Reed, S Grond and E Pierce are employees of Eli Lilly and Company This analysis was sponsored by Eli Lilly and Company. This study is previously presented at American Academy of Dermatology (AAD); Boston, USA; 25-29 March 2022 Study was sponsored by Eli Lilly and Company BACKGROUND ■ Atopic Dermatitis (AD) is a common inflammatory skin disease with symptoms including itching, dry, red and scaly skin. ■ Itch and associated skin pain can frequently lead to sleep disruption (S-D) among patients with AD with resulting daytime fatigue and disturbed cognition.1, 2 ■ While recent studies have demonstrated a link between higher AD severity and reduced sleep quantity and quality,3 real-world data for AD from the patient perspective is still limited and the role of S-D frequency and its impact on patient quality of life (QoL) requires further exploration. KEY RESULTS Winter Clinical Dermatology Conference; Hawaii, USA; January 13-18, 2023 Figure 2. WPAI due to AD in moderate-to-severe adult AD patients according to the frequency of S-D. Figure 3. Mean DLQI and POEM scores in moderate-to-severe adult AD patients according to the frequency of S-D. Figure 1. Patient-reported day-to-day symptoms in moderate-to-severe adult AD patients according to the frequency of S-D. 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. All patients (n=719) Frequent S-D (n=162) Infrequent S-D (n=557) p-value Mean age (years) 38.5 ± 14.5 37.0 ± 14.5 38.9 ± 14.4 0.142 Male, n (%) 347 (48.3%) 83 (51.2%) 264 (47.4%) 0.390 Body mass index (kg/m2) 25.7 ± 13.4 26.9 ± 27.2 25.3 ± 4.1 0.175 Psychological comorbidities, n (%) Anxiety Depression 132 (18.4%) 69 (9.6%) 29 (17.9%) 18 (11.1%) 103 (18.5%) 51 (9.2%) 0.864 0.457 Employeda, n (%) 549 (64.6%) 97 (60.2%) 362 (65.8%) 0.194 Time since AD diagnosis (years)b 10.9 ± 12.1 12.3 ± 11.9 10.5 ± 12.1 0.192 Current EASI score 9.9 ± 8.0 12.2 ± 10.0 9.2 ± 7.3 <0.001 Current BSA affected (%)c 23.7 ± 16.2 24.5 ± 17.1 23.5 ± 16.0 0.512 Results are presented as mean ± standard deviation unless stated otherwise aN=711, 161 and 550 for the three groups, respectively; bN=433, 98 and 335 for the three groups, respectively; cN=627, 140 and 487 for the three groups, respectively AD, atopic dermatitis; S-D, sleep disruption RESULTS  719 patients with a physician assessment of moderate or severe AD completed the PRO questionnaire and were included in this analysis o 22.5% experienced day-to-day frequent S-D and 77.5% infrequent S-D.  Table 1 shows patient demographics and clinical characteristics.  Patients with patient-reported day-to-day frequent S-D were significantly more likely to experience frequent itch, skin pain, anxiety and depression than those with infrequent S-D (Figure 1). CONCLUSIONS ■ More than one fifth of moderate-to-severe adult AD patients experience S-D regularly or all the time. ■ Compared with infrequent S-D patients, frequent S-D patients have significantly more frequent day-to-day itch and are also more likely to experience skin pain, anxiety and depression more frequently. ■ Patients with frequent S-D have greater activity/work productivity impairment and higher disease burden. ■ These results reinforce the link between itch, skin pain, anxiety, and depression with S-D. and underline the importance of sleep for patient’s QoL.  The patient questionnaire included the following validated PRO assessments: o Patient Orientated Eczema Measure (POEM)4,5 o Dermatology Life Quality Index (DLQI)6 o Work Productivity and Activity Impairment (WPAI)7  Statistical comparisons for the two patient groups were made using pairwise t-tests for continuous variables and chi-squared for categorical variables. ■ Overall work and activity impairment due to AD was significantly increased in patients with frequent S-D than those with infrequent S-D, as shown in Figure 2. ■ Figure 3 shows burden of disease on QoL and AD symptoms was higher for patients with frequent versus infrequent S-D. OBJECTIVE  To assess the impact of day-to-day (not related to a flare) S-D frequency on patients with moderate-to- severe AD using patient-reported outcomes (PROs). STRENGTHS AND LIMITATIONS Strengths Adelphi DSPs provide data from large international databases, providing real- world information on disease characteristics, management and outcomes Limitations Assessment of AD severity was not based on a standardized definition but utilised physician judgement. The S-D definition was based on patient-report rather than a standardised measure and rated in terms of frequency and not intensity. The study was limited by factors associated with any survey, such as accurate recall and variability in the interpretation of questions Point-in-time design therefore cannot be used to demonstrate cause and effect REFERENCES 1. Maarouf M, et al. Dermatitis.2018;29:278-281. 2. Yu SH, et al. Dermatitis. 2016;27:50-58. 3. Bruin-Weller M, et al. J Dermatolog Treat. 2021;32:164-173. 4. Charman CR, et al. Arch Dermatol. 2004;140:1513⎼9. 5. Charman CR, et al. Br J Dermatol. 2013;169:1326⎼32. 6. Finlay AY, Khan GK. Clin Exp Dermatol. 1994;19:210⎼6. 7. Reilly MC, et al. Pharmacoecomics. 1993;4:353⎼65. Slide Number 1