SYNOPSIS • Psoriasis is a chronic, systemic, immune-mediated disease of the skin that affects > 7.4 million people in the United States, with an estimated prevalence of 2% to 4%1 • Secukinumab is a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, a cornerstone cytokine involved in the development of psoriasis2 • Secukinumab has demonstrated efficacy in clinical trails and effectiveness in real-world settings in the treatment of patients with psoriasis3-9 • However, there remain limited real-world data characterizing US patients with psoriasis who initiate secukinumab in routine clinical practice OBJECTIVE • To describe demographic and clinical characteristics of US patients with plaque psoriasis who initiated secukinumab in clinical practice, using clinical data obtained from the Modernizing Medicine Data Services (MMDS) electronic medical records (EMRs) dermatology panel METHODS Study Design and Patient Population • All data were collected from Modernizing Medicine’s Electronic Medical Assistant (EMA) system – EMA delivers structured, real-world data captured from > 500,000 unique patients with psoriasis – Data from EMRs for patients in the United States with a clinical diagnosis of psoriasis were deidentified in accordance with HIPAA (Health Insurance Portability and Accountability Act) for research use • Eligible patients in the MMDS database had a diagnosis of plaque psoriasis during the study period of July 1, 2014, to March 31, 2018, had ≥ 1 prescription order for secukinumab within the index period (January 1, 2015, to September 30, 2017), and were aged ≥ 18 years at the time of secukinumab initiation (index date) • Patients had ≥ 1 clinical visit for any reason during the 6-month pre-index (baseline) period and ≥ 1 clinical visit for any reason within the first and second 6 months following secukinumab initiation (12-month follow-up period) Study Variables and Data Analysis • Demographic characteristics (age, sex, race, body weight, US region), treatment history (during 6-month pre-index period only), and clinical characteristics (comorbidities, psoriasis subtype, body surface area [BSA], and Physician Global Assessment [PGA]) were assessed by dermatology providers during the 6-month baseline period Demographic and Clinical Characteristics of Patients With Plaque Psoriasis Initiating Secukinumab in Clinical Practice: Data From US Dermatology Electronic Medical Records Paul S. Yamauchi, MD, PhD,1 Chi-Chang Chen, PhD,2 Yao Ding, PhD,2 Rebecca Germino, PhD3 1UCLA School of Medicine, Santa Monica, CA; 2IQVIA, Plymouth Meeting, PA; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ Scan QR code to download this poster. Presented at the 2019 Winter Clinical Dermatology Conference; January 18-23, 2019; Koloa, HI. Your document will be available for download at the following URL: URL: http://novartis.medicalcongressposters.com/Default.aspx?doc=ecd09 And via Text Message (SMS) Text: Qecd09 To : 8NOVA (86682) US Only +18324604729 North, Central and South Americas; Caribbean; China +447860024038 UK, Europe & Russia +46737494608 Sweden, Europe Note: downloading data may incur costs which can vary depending on your service provider and may be high if you are using your smartphone abroad. Please check your phone tariff or contact your service provider for more details. Table 1. Demographics of Patients With Psoriasis Who Initiated Secukinumab and Had 12 Months of Follow-Up Characteristic Patients With 12-Month Follow-Up (N = 4996) Age, mean (SD), years 51.6 (13.7) Male, n (%) 2524 (50.5) US region, n (%) South 2070 (41.4) West 1080 (21.6) Midwest 1036 (20.7) Northeast 802 (16.1) Unknown 8 (0.2) Race, n (%) White 3317 (66.4) Black 141 (2.8) Asian 129 (2.6) Hispanic 92 (1.8) Other/unknown 1317 (26.4) Index year, n (%) 2015 1131 (22.6) 2016 2096 (42.0) 2017 1769 (35.4) Comorbidities and Treatment History During the Baseline Period • The most common comorbidities were hypertension (29.8%), psoriatic arthritis (22.2%), and diabetes (17.6%) (Table 2) • Overall, 42.5% of patients received prior biologic treatment during the 6-month baseline period, of whom 54.0% received tumor necrosis factor inhibitors, 47.6% received ustekinumab, and 3.2% received another IL-17A inhibitor (Table 2) Table 2. Comorbidities and Treatment History of Patients With Psoriasis Who Initiated Secukinumab and Had 12 Months of Follow-Up Characteristic Patients With 12-Month Follow-Up (N = 4996) Comorbidities, n (%) Hypertension 1487 (29.8) Psoriatic arthritis 1110 (22.2) Diabetes 877 (17.6) Hyperlipidemia 751 (15.0) Malignancies 633 (12.7) Coronary heart disease 125 (2.5) Cerebrovascular disease* 70 (1.4) Obesity 55 (1.1) Rheumatoid arthritis 24 (0.5) Treatment history Prior biologic treatment preceding secukinumab claim, n (%) Tumor necrosis factor inhibitors† 1148 (54.0) Ustekinumab 1011 (47.6) IL-17A inhibitors‡ 69 (3.2) IL, interleukin. * Cerebrovascular disease included hemorrhagic stroke and transient ischemic attack. † Tumor necrosis factor inhibitors included adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab. ‡ IL-17 inhibitors included brodalumab and ixekizumab. Clinical Characteristics During the Baseline Period • At baseline, the mean (SD) BSA was 23.0% (22.5%), and 58.1% had severe disease (BSA > 10%) (Figure 1A) • The mean (SD) PGA score was 2.92 (1.19), and 72.0% had moderate-to-severe involvement (PGA score 3-5) (Figure 1B) Figure 1. Categorical Clinical Outcome Measures* in Patients Who Initiated Secukinumab and Had 12 Months of Follow-Up BSA, body surface area; PGA, Physician Global Assessment. * Available effectiveness records for PGA scores and BSA affected by psoriasis were reported based on the index visit or the visit closest to the index with such values during the 6-month baseline period. 9.3% n = 191 32.6% n = 670 58.1% n = 1196 Baseline BSA Category Baseline Categorical BSA (N = 2057) Mild (< 3%) Moderate (3%-10%) Severe (> 10%) Mean (SD), 23.0% (22.5%) 4.0% n = 64 9.2% n = 149 14.9% n = 241 44.1% n = 714 18.6% n = 301 9.3% n = 150 Baseline PGA Category Baseline Categorical PGA (N = 1619) Clear (0) Minimal (1) Mild (2) Moderate (3) Marked (4) Severe (5) Mean (SD), 2.92 (1.19) A 0 10 20 30 40 50 60 P ro po rt io n of P at ie nt s, % B 0 5 10 15 20 25 30 35 40 45 50 P ro po rt io n of P at ie nt s, % DISCLOSURES P. S. Yamauchi has served as an investigator for Amgen, Celgene, Dermira, Galderma, Janssen, LEO Pharma, Eli Lilly, MedImmune, Novartis, Pfizer, Regeneron, and Sandoz and has served as an advisor and/or speaker for AbbVie, Amgen, Baxter, Celgene, Dermira, Galderma, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, and Regeneron. C.-C. Chen and Y. Ding are employees of IQVIA who received consulting fees to conduct this research. R. Germino is an employee of Novartis Pharmaceuticals Corporation. ACKNOWLEDGMENTS Support for third-party writing assistance for this poster, furnished by Meaghan Paganelli, PhD, of Health Interactions, Inc, was provided by Novartis Pharmaceuticals Corporation, East Hanover, NJ. This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ. © 2018 Novartis Pharmaceuticals Corporation. LIMITATIONS • The MMDS database included data captured only from physicians contributing to the EMR network (that was then de-identified), and results may not be generalizable to all patients with psoriasis • No continuous health plan enrollment information was captured in the EMR database • Patients with comorbid psoriatic arthritis or ankylosing spondylitis initiating secukinumab were not excluded from the study population, leading to potential confounding variables CONCLUSION • In this US real-world data analysis of patients with plaque psoriasis, most patients initiating secukinumab had moderate-to-severe disease, > 20% of patients had concomitant psoriatic arthritis, and the most common prior biologic treatment was tumor necrosis factor inhibitors during the 6-month baseline period • Overall, these findings are consistent with patient characteristics and severity of psoriasis exhibited in clinical trials and provide additional insight into characteristics and treatment history of patients initiating secukinumab in real-world settings REFERENCES 1. Rachakonda TD, et al. J Am Acad Dermatol. 2014;70(3):512-6. 2. Lynde CW, et al. J Am Acad Dermatol. 2014;71(1):141-50. 3. Langley RG, et al. N Engl J Med. 2014;371(4):326-38. 4. Blauvelt A, et al. Br J Dermatol. 2015;172(2):484-93. 5. Paul C, et al. J Eur Acad Dermatol Venereol. 2015;29(6):1082-90. 6. Thaci D, et al. J Am Acad Dermatol. 2015;73(3):400-9. 7. Armstrong AW, et al. J Clin Aesthet Dermatol. 2016;9(6 suppl 1):S12-6. 8. Mease P, et al. Ann Rheum Dis. 2018;77(6):890-7. 9. Bagel J, et al. Poster presented at: 27th European Academy of Dermatology and Venereology Congress; September 12, 2018; Paris, France [ePoster P1850]. RESULTS Patient Demographics During the Baseline Period • Of 803,036 patients in the MMDS database who had a diagnosis of plaque psoriasis during the study period, 4996 patients met the inclusion criteria and had 12 months of follow-up • At baseline, the mean (SD) age was 51.6 (13.7) years, 50.5% were male, and 66.4% were white (Table 1) • All US geographic regions were represented: 41.4% were from the South, 21.6% from the West, 20.7% from the Midwest, and 16.1% from the Northeast regions (Table 1)