PowerPoint Presentation Early Insights into the Characteristics of Tralokinumab Patients in a Real-World Setting in the United States Raj Chovatiya1, Sanjeev Balu2, Yestle Kim2, Amanda G. Althoff3, Lawrence Rasouliyan3 1. Northwestern University Feinberg School of Medicine, Chicago, IL; 2. LEO Pharma, Madison, NJ; 3. OMNY Health, Atlanta, GA Table 2. Baseline demographic characteristics at Index Tralokinumab Prescription Conclusions • This study provides early insights into the baseline characteristics of tralokinumab patients in a real-world setting in the US • While many characteristics were similar between biologic-naïve and biologic- experienced patients, a higher proportion of biologic-experienced patients had a greater degree of documented disease severity • Understanding the types of patients who were being prescribed tralokinumab may help identify other patients who may benefit from tralokinumab to manage their moderate- to-severe AD • Additional real-world studies are required to observe the changes in clinical outcomes after the initiation of tralokinumab over a longer period of time Objective The objective of this study was to understand the demographic, medical history, and clinical baseline characteristics of adult patients who were prescribed tralokinumab for the treatment of AD in a real- world setting. Materials and Methods • This retrospective, observational, descriptive study used electronic health record (EHR) data from the OMNY Health platform • The OMNY Health platform is comprised of approximately 1,500 dermatologists and clinicians from integrated delivery networks and ambulatory dermatology practices in the US • Patients who met both of the following criteria were included: • Ever had a prescription for tralokinumab from February 2022 to September 2022 • 18 years or older at the date of first the tralokinumab prescription • Patients were further divided into two groups for comparative analysis: biologic-naïve and biologic- experienced. The biologic-experienced group was composed of patients who had a history of dupilumab prescription in their medical history, as it was the only US-approved biologic for AD prior to tralokinumab • Deidentified EHR data was summarized to report descriptive statistics of the patient characteristics • The study index date was the date of the first tralokinumab prescription • Baseline clinical characteristics, demographic, and prescription data were collected from the index date and the time period preceding the index date • All variables were derived from EHRs that were populated during patient encounters in the real-world healthcare setting: • Patient demographics (age, gender, race, and weight) • Treatment characteristics (dose and prescriber) • Disease activity metrics (body surface area [BSA], investigator’s global assessment [IGA], itch numerical rating scale [NRS] score) • Comorbidities • Treatment history and concomitant medications Results Patient Population • As of September 2022, 195 adult patients met the criteria for this analysis (Table 1) • Of the 195, 105 (54%) had a previous prescription of dupilumab (biologic-experienced) Disclosures RC has served as an advisory board member, consultant, and/or investigator for AbbVie, Apogee, Arcutis, Arena, Argenx, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer Inc., Regeneron, Sanofi, and UCB, and speaker for AbbVie, Arcutis, Dermavant, Eli Lilly and Company, EPI Health, Incyte, LEO Pharma, Pfizer Inc., Regeneron, Sanofi, and UCB. SB and YK are employees of LEO Pharma. AGA and LR are employees of OMNY Health and have received research funding from LEO Pharma. Introduction • Tralokinumab-ldrm (AdbryTM) was approved in the United States (US) in December 2021 for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients • Real-world characteristics of patients prescribed tralokinumab are not yet understood Comorbidities and Treatment History • In the entire cohort, the most documented comorbidities were systemic infection and skin infection (Figure 1) • A higher proportion of biologic-experienced patients had systemic infection (29.5%) and skin infection (20.0%) compared to the biologic-naïve patients (16.7% and 14.4%, respectively; Figure 1) • History of asthma was recorded in less than 20% of the entire cohort, and it was more prevalent in biologic-experienced patients (14.3% vs 3.3%; Figure 1) • Overall, the most common previously used AD treatments were topical corticosteroids, topical calcineurin inhibitors, and systemic corticosteroids. All these treatments were more prevalent among the biologic-experienced vs biologic-naïve patients (Table 3) Patient Demographics • Majority of patients were female, >50 years old, and self-identified as White race (Table 2) • Biologic-naïve patients, on average, had a higher proportion of females and were older than biologic- experienced patients Table 3. Treatment History at Index Tralokinumab Prescription Clinical Characteristics at Baseline • Dermatologists were more likely to prescribe tralokinumab to biologic-naïve patients than biologic- experienced patients (43.2% vs 30.4%); the opposite trend was observed for nurse practitioners (5.7% for biologic-naïve patients; 14.7% for biologic-experienced patients) (Table 4) • Among patients with available disease activity data, approximately 79% had moderate or severe AD per their recorded index IGA score • The mean AD-affected BSA at index was 22.0% and the mean itch NRS score was 5.7 (range: 0 to 10) • More biologic-experienced patients had severe AD compared to their biologic-naïve counterparts, while the opposite trend was observed with moderate AD • A larger proportion of biologic-experienced patients had documented AD involvement of the face and hands compared to the biologic-naïve patients Table 1. Patient Criteria Figure 1. Medical History and Comorbidities at Index Tralokinumab Prescription Winter Clinical Dermatology Conference – Miami, February 14- 20, 2023 Criteria N Ever had a prescription for tralokinumab 198 AND Age 18 years or older at time of first tralokinumab prescription 195 Biologic Naïve 90 Biologic Experienced 105 Study Limitations • The OMNY Health platform did not include all EHRs across the entire US, which may limit generalizability • As with all EHRs, clinicians may not have documented disease activity measures consistently within the structured data, resulting in missing data • Other treatments, diagnoses, and health events occurring outside of these settings or outside of this time period may not have been captured in this data source; thus, only data that the provider chose to record in the structured EHR fields were available for analysis Study Population N = 195 Biologic Naive N = 90 Biologic Experienced N = 105 Gender, n (%) n = 195 n = 90 n = 105 Female 107 (54.9%) 55 (61.1%) 52 (49.5%) Male 88 (45.1%) 35 (38.9%) 53 (50.5%) Age (years) n = 195 n = 90 n = 105 Mean (SD) 50.9 (18.2) 54.1 (18.7) 48.2 (17.5) Median (Q1, Q3) 53.0 (36.5, 62.5) 57.5 (40.2, 66.0) 50.0 (34.0, 60.0) Min, Max 18, 90 20, 90 18, 90 Race, n (%) n = 112 n = 47 n = 65 White 87 (77.7%) 34 (72.3%) 53 (81.5%) Black or African American 18 (16.1%) 10 (21.3%) 8 (12.3%) American Indian or Alaska Native 1 (0.9%) 1 (2.1%) 0 (0.0%) Asian 3 (2.7%) 1 (2.1%) 2 (3.1%) Other 3 (2.7%) 1 (2.1%) 2 (3.1%) Ethnicity, n (%) n = 81 n = 39 n = 42 Hispanic or Latino 7 (8.6%) 2 (5.1%) 5 (11.9%) Not Hispanic or Latino 74 (91.4%) 37 (94.9%) 37 (88.1%) Region, n (%)* n = 193 n = 89 n = 104 Northeast 28 (14.5%) 12 (13.5%) 16 (15.4%) Southeast 83 (43.0%) 41 (46.1%) 42 (40.4%) Southwest 43 (22.3%) 22 (24.7%) 21 (20.2%) Midwest 37 (19.2%) 13 (14.6%) 24 (23.1%) West 2 (1.0%) 1 (1.1%) 1 (1.0%) Study Population N = 195 Biologic Naive N = 90 Biologic Experienced N = 105 Topical corticosteroids 157 (80.5%) 69 (76.7%) 88 (83.8%) Topical calcineurin inhibitors 74 (37.9%) 28 (31.1%) 46 (43.8%) Systemic corticosteroids 68 (34.9%) 30 (33.3%) 38 (36.2%) Ruxolitinib cream 44 (22.6%) 14 (15.6%) 30 (28.6%) Crisaborole 34 (17.4%) 10 (11.1%) 24 (22.9%) Systemic immunosuppressants 18 (9.2%) 7 (7.8%) 11 (10.5%) Phototherapy 12 (6.2%) 3 (3.3%) 9 (8.6%) Janus kinase inhibitors 3 (1.5%) 0 (0.0%) 3 (2.9%) Other biologic* 3 (1.5%) 2 (2.2%) 1 (1.0%) Apremilast 2 (1.0%) 1 (1.1%) 1 (1.0%) Antidepressants 2 (1.0%) 0 (0.0%) 2 (1.9%) Tapinarof cream 0 (0.0%) 0 (0.0%) 0 (0.0%) Roflumilast cream 0 (0.0%) 0 (0.0%) 0 (0.0%) Study Population N = 195 Biologic Naive N = 90 Biologic Experienced N = 105 Clinician taxonomy, n (%) n = 190 n = 88 n = 102 Dermatology 69 (36.3%) 38 (43.2%) 31 (30.4%) Physician assistant 86 (45.3%) 39 (44.3%) 47 (46.1%) Nurse practitioner 20 (10.5%) 5 (5.7%) 15 (14.7%) Internal medicine 1 (0.5%) 1 (1.1%) 1 (1.0%) Other 1 (0.5%) 5 (5.7%) 8 (7.8%) AD-affected body surface area percent n = 83 n = 40 n = 43 Mean (SD) 22.0 (19.9) 21.0 (17.2) 22.9 (22.2) Median (Q1, Q3) 15.0 (9.5, 28.0) 20.0 (10.0, 26.0) 15.0 (8.0, 30.0) Min, Max 0, 100 1, 70 0, 100 Investigator’s global assessment, n (%) n = 56 n = 26 n = 30 Clear 3 (5.4%) 0 (0.0%) 3 (10.0%) Almost Clear 2 (3.6%) 2 (7.7%) 0 (0.0%) Mild 7 (12.5%) 3 (11.5%) 4 (13.3%) Moderate 32 (57.1%) 16 (61.5%) 16 (53.3%) Severe 12 (21.4%) 5 (19.2%) 7 (23.3%) Itch numerical rating scale (0 to 10 scale) n = 35 n = 19 n = 16 n 35 19 16 Mean (SD) 5.7 (2.6) 6.1 (2.6) 5.2 (2.7) Median (Q1, Q3) 6.0 (4.0, 8.0) 6.0 (4.5, 8.0) 5.0 (3.8, 7.2) Min, Max 1, 10 1, 10 1, 10 AD current/previous face involvement, n (%) n = 26 n = 14 n = 12 Yes 4 (15.4%) 2 (14.3%) 2 (16.7%) No 22 (84.6%) 12 (85.7%) 10 (83.3%) AD current/previous hand involvement, n (%) n = 26 n = 14 n = 12 Yes 11 (42.3%) 5 (35.7%) 6 (50.0%) No 15 (57.7%) 9 (64.3%) 6 (50.0%) Table 4. Clinical Characteristics at Index Tralokinumab Prescription *Geographic region was defined based on observed values as follows: Northeast (MD, PA), Southeast (FL, GA, NC, SC, TN, VA, WV), Southwest (AZ, TX), Midwest (IL, IN, KS, MI, MN, MO, OH), and West (CO). Acknowledgement Writing support was provided by YK and OMNY Health. LEO Pharma sponsored this analysis and the production of this poster. *Other biologics include the following: certolizumab pegol, secukinumab, etanercept, adalimumab, tildrakizumab-asmn, infliximab, brodalumab, golimumab, risankizumab-rzaa, ustekinumab, ixekizumab, and/or guselkumab 16.7% 14.4% 10.0% 3.3% 5.6% 2.2% 29.5% 20.0% 13.3% 14.3% 4.8% 6.7% 0% 5% 10% 15% 20% 25% 30% 35% Any systemic infection Any skin infection Any cardiovascular disease Asthma Any oncologic disease Allergic rhinitis Percent of Patients with History of Medical Condition Biologic Naïve (n=90) Biologic Experienced (n=105)