SKIN November 2022 Volume 6 Issue 6 (c) 2022 THE AUTHORS. Published by the National Society for Cutaneous Medicine. 502 RESEARCH LETTER Biologic Treatment of Psoriasis and Tuberculosis Testing: A Retrospective Analysis Emma Batchelder, MD1, Mara Trifoi, BS2, Julie Hong, BS2, Steven Maczuga, MS3, Joslyn Sciacca Kirby, MD, MS, MEd3 1 Department of Psychiatry, Penn State Health, Hershey, PA 2 Penn State College of Medicine, Hershey, PA 3 Department of Dermatology, Penn State Health, Hershey, PA Several biologic therapies are commonly used for the treatment of moderate-to-severe psoriasis1,2, including tumor necrosis factor (TNF)-α inhibitors. These treatments may increase the risk of reactivation of latent tuberculosis infection (LTBI) or active tuberculosis (TB) infection.3 While the Unites States (US) has a low TB burden4, it is recommended that patients have a pretreatment test with discretionary testing thereafter for all but high-risk patients3. This ABSTRACT Background: Current recommendations for biologic use in psoriasis recommend baseline TB screening with IGRA. Studies have found in low TB prevalence countries that TB conversion occurs at low rates in those utilizing biologic therapies. Objectives: To evaluate utilization and cost effectiveness of TB testing in patients with psoriasis being treated with biologics. Methods: We retrospectively queried a national commercial claims database (Truven Health MarketScan) from 1/1/2014 to 12/31/2018 to investigate the use of TB screening and disease prevalence among patients with psoriasis being treated with a biologic agent. Inclusion criteria consisted of psoriasis disease status, continuous utilization of a biologic for one year prior and three years after the first biologic claim; and no claims for TB within the year prior to starting the biologic. Results: 3,421 patients with psoriasis and concurrent biologic treatment use were included in the study. 84.7% (2,897) had a baseline TB test within 15 months prior to first claim of biologic use. Baseline tests were primarily IGRA (75.8%, n=2,195) with PPD tests only being used in 24.2% (n = 702) of patients. Total cost for baseline TB test in the cohort amounts to $738,117. TB tests were positive in 4.1% (n = 147) of patients and TNF- α inhibitors was the most frequently prescribed biologic. Conclusions: The majority of patients diagnosed with psoriasis had a claim for baseline TB testing. Current recommendations surrounding biologics and TB screening should take into account the high cost of baseline TB testing and the low rate of TB prevalence among patients on biologics. INTRODUCTION SKIN November 2022 Volume 6 Issue 6 (c) 2022 THE AUTHORS. Published by the National Society for Cutaneous Medicine. 503 paper examines the utilization and cost of TB testing for US patients with psoriasis treated with biologics. A retrospective cohort study was conducted from 1/1/2014 to 12/31/2018 using the Truven Health MarketScan Commercial Claims Database (Ann Arbor, MI), which contains healthcare claims from approximately 350 payers in the US. Inclusion criteria included psoriasis (1+ claims with International Classification of Diseases version [ICD]-9: 696.1 or ICD-10: L40.0/L40.1/L40.4/L40.8/L40.9), 1+ claims for one a biologic therapy including: etanercept, adalimumab, ustekinumab, brodalumab, certolizumab, guselkumab, infliximab, ixekizumab, or secukinumab; continuous enrollment for one year prior to and three years after the first biologic claim; and no claims for TB within the year prior to starting the biologic. Demographic characteristics, TB diagnosis (LTBI: latent Tb - ICD-9 795.51/795.52 ICD-10 R76.11/R76.12; Active TB: ICD-9 10-18, ICD-10 A15/A17/A18/A19) as well as frequency and costs for TB testing were extracted. Common Procedural Terminology (CPT) codes were used to identify purified protein derivative (PPD) test and interferon gamma release assay (IGRA) claims (CPT 86580 and 86480/86481, respectively). Costs were taken from the perspective of the health-system and were adjusted for inflation to 2020 US dollars (https://www.usinflationcalculator.com/). Analyses were performed with SAS version 9.4 (SAS, Cary, NC). Overall, 3,421 patients with psoriasis and biologic treatment were included (Table 1). Of these, 84.7% (n=2,897) had a baseline TB test (within 15 months prior or three months after first claim for starting a biologic). The majority of baseline tests were IGRA (75.8%, n=2,195) with PPD accounting for 24.2% (n=702). Annual testing was performed in the minority (18.0%, n=1034) and of these 92.9% (961/1034) received a TNF-inhibitor. The majority (96.7%, n=2,129) had less frequent testing (mean=9.22 (standard deviation [SD] 13.44)) months. Repeat testing, defined as a second claim within 30 days, was performed for 1.3% (n=29). Of these, the majority (27.6%, n=8) had a PPD as the first test and 72.4% (n=21) had an IGRA. The total cost of testing for the cohort was $738,117. TB tests were positive in 4.1% (n=147/3,559). Most patients with a positive TB test had no biologic prescription within 30 days (53.6% [233/435])). For those prescribed a biologic, TNF-α inhibitor was most frequently prescribed, including etanercept (18.4% [42/228]), adalimumab (43.9% [100/228]), infliximab (1.3% [3/228]), or certolizumab (2.2% [5/228]) compared to other biologics including secukinumab (10.5% [24/228]) (Table 2). The majority of people with psoriasis treated with a biologic did not have a claim for baseline TB testing. Of those tested at baseline, the majority did not have subsequent annual testing. The rate of TB in the US is low5 and TB testing can be non- specific, thus the value of routine widespread testing should be reconsidered. Current recommendations do not require annual testing and suggest that patients be instead screened for symptoms and risk factors for TB.3 While guidelines recommend IGRA METHODS RESULTS DISCUSSION https://www.usinflationcalculator.com/ SKIN November 2022 Volume 6 Issue 6 (c) 2022 THE AUTHORS. Published by the National Society for Cutaneous Medicine. 504 Table 1. Sample characteristics (n=3,421) Demographic n % Sex Male 1,655 48.38% Female 1,766 51.62% Age Group 0-17 56 1.64% 18-34 363 10.61% 35-44 725 21.19% 45-54 1,092 31.92% 55-64 1,185 34.64% Region Northeast 620 18.12% North Central 685 20.02% South 1,731 50.60% West 380 11.11% Unknown 5 0.15% SKIN November 2022 Volume 6 Issue 6 (c) 2022 THE AUTHORS. Published by the National Society for Cutaneous Medicine. 505 Table 2. Tuberculosis testing utilization and costs n (%) Cost* Baseline TB test performed Yes No 2,897 (84.7%) 344 (10.1%) Total: $738,117 -- Baseline TB test type PPD IGRA 702 (24.2%) 2,195 (75.8%) Total: $56.43 (29.57)^ Testing Frequency n (%) Months between any TB test Mean (SD) Tested annually 72 (3.3%) 12.5 (1.2) Tested at interval other than annually 2,129 (96.7%) 33.1 (48.1) TB Diagnosis Yes No Age, mean (SD) 51.0 (9.9) 47.5 (11.9)** Sex, male, n (%) (51.7%) (48.6%) Months on biologic, mean (SD) 20.4 (11.3) 20.1 (11.7) *Cost adjusted for inflation to 2020 US dollars ^Mean (SD), median cost per test **p-value <.001 SKIN November 2022 Volume 6 Issue 6 (c) 2022 THE AUTHORS. Published by the National Society for Cutaneous Medicine. 506 rather than PPD, we found that IGRA was used infrequently.6 There are limitations to this study; clinical risk factors for TB were not examined and only patients with private insurance were included. Overall, this data suggests that there is an opportunity to re- evaluate the value of TB laboratory screening given these trends, the low TB infection rate in the US, and the cost and consequences of false-positive tests. Conflict of Interest Disclosures: None Funding: None Corresponding Author: Joslyn S. Kirby, MD, MS, MEd, Department of Dermatology Penn State Health Milton S. Hershey Medical Center 500 University Dr Hershey, PA 17033 Email: jkirby1@pennstatehealth.psu.edu References: 1. Boehncke WH, Schön MP. Psoriasis. Lancet. 2015;386(9997):983-994. 2. Karataş Toğral A, Muştu Koryürek Ö, Şahin M, Bulut C, Yağci S, Ekşioğlu HM. Association of clinical properties and compatibility of the QuantiFERON-TB Gold In-Tube test with the tuberculin skin test in patients with psoriasis. Int J Dermatol. 2016;55(6):629-633. 3. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. 4. Global tuberculosis report 2019. In. Geneva: World Health Organization 2019. 5. Schmit KM, Wansaula Z, Pratt R, Price SF, Langer AJ. Tuberculosis - United States, 2016. MMWR Morb Mortal Wkly Rep. 2017;66(11):289-294. 6. Lewinsohn DM, Leonard MK, LoBue PA, et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Infect Dis. 2017;64(2):111-115.