372 Early insights into the characteristics of tralokinumab patients in a real-world setting in the United States
Authors: Chovatiya Raj , Balu Sanjeev , Kim Yestle , Althoff Amanda G , Rasouliyan Lawrence 
Published: June 2023

Abstract
Tralokinumab was approved in December 2021 in the USA for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. Real-world characteristics of patients prescribed tralokinumab are not yet understood. This study aims to characterize the demographic, medical history and clinical baseline characteristics of patients prescribed tralokinumab in US dermatology practices and integrated delivery networks. A retrospective analysis of adult patients prescribed tralokinumab between February and October 2022 was conducted using electronic health record data from OMNY Health, a data platform comprising patients from US specialty and integrated delivery networks. Patients were indexed at first tralokinumab prescription and further divided into two groups for comparative analysis: biologic-naïve vs. biologic-experienced. Descriptive statistics (demographics, medical history/comorbidities and treatment history/concomitant prescriptions) were also analysed. A total of 195 tralokinumab patients were included, of which the majority were female (55%), ≥50 years old (56%) and self-identified as White race (78%). More than half (54%) were previously treated with dupilumab. Among biologic-naïve vs. biologic-experienced patients, a higher proportion was female (61% vs. 50%) and older (mean age: 54 vs. 48 years). Among the biologic-experienced subset, at baseline, the most common documented comorbidities were systemic infection (30%), skin infection (20%) and asthma (14%), while in the biologic-naïve subset, 17% had systemic infection, 14% had skin infection and 9% had asthma. Overall, commonly used AD treatments among all patients were topical corticosteroids (81%), topical calcineurin inhibitors (38%) and systemic corticosteroids (35%). Use of these medications was increased among biologic-experienced vs. biologic-naïve individuals. More dermatologists vs. nurse practitioners prescribed tralokinumab to biologic-naïve patients (43% vs. 30%); more nurse practitioners prescribed tralokinumab as second line to biologic-experienced patients compared with first line in biologic-naïve patients (15% vs. 6%). Among tralokinumab patients with available data, baseline mean AD-affected body surface area (n = 83) was 22%, and mean numeric rating scale itch score (n = 35) was 5.7 (range 0–10). Seventy-nine percent of 56 patients with available data had moderate or severe disease per investigator’s global assessment. The AD involvement of the face and hands (n = 26) was documented in 15% and 42%, respectively. A larger proportion of biologic-experienced patients had severe disease vs. their biologic-naïve counterparts (23% vs. 19%), while the opposite trend was seen with moderate disease (53% vs. 62%). This study provides early insights into the characteristics of tralokinumab patients in a real-world setting. While many characteristics were similar between biologic-naïve and biologic-experienced patients, a higher proportion of biologic-experienced patients had more clinician-assessed severe disease vs. the biologic-naïve subset. Tralokinumab was prescribed at similar rates as first- or second-line biologic therapy. The small sample size of this descriptive analysis limits generalizability of these results. Additional prospective studies are needed to observe the changes in real-world clinical outcomes in tralokinumab patients over time.