Poster Central Dermatology, Saint Louis, Missouri, USA; 2 ICON Epidemiology, Vancouver, British Columbia, Canada;

Transcription

1 Poster 8211 Disease Severity and Quality of Life among Ixekizumab- Treated Psoriasis Patients in the Real-World Setting: Results from a Single US Dermatology Referral Practice Craig Leonardi 1, Aleksandra Gara 2, David Amato 3, Katherine Osenenko 2, Solmaz Setayeshgar 2, Sisi Wang 2, Mwangi J. Murage 3, Chen-Yen Lin 3, William N. Malatestinic 3 1 Central Dermatology, Saint Louis, Missouri, USA; 2 ICON Epidemiology, Vancouver, British Columbia, Canada; 3 Eli Lilly and Company, Indianapolis, Indiana, USA American Academy of Dermatology Annual Meeting, Washington D.C. March 1-5, 2019 This study was sponsored by Eli Lilly and Company.

2 Objective and Methods Objective Assess disease severity and quality of life (QoL) at 3-month intervals over the first year of ixekizumab (IXE) treatment among psoriasis patients at a single US dermatology referral practice. Study Design Retrospective observational cohort study, using chart review methodology. Setting Single US dermatology referral practice in Saint Louis, MO. Population Adult psoriasis patients initiating IXE (index) between March 22, 2016 (IXE approval date) and February 28, Exclusion criteria: Any prior IXE treatment, or any clinical trial participation during study period. Data Collection Data were collected from medical charts, for the year prior to index and from index until Feb.28, 2018, or IXE discontinuation, whichever was first. Statistical Analyses Summary statistics were generated for patient characteristics and prior treatments received. Body surface area (BSA), static Physician Global Assessments (spga) and Dermatology Quality of Life (DLQI) were summarized at 1 month post-index and at 3-month intervals pre and post-index. Post-index results are presented here for patients with data available at each time point (+/- 45 days).

3 Results (1) Patient characteristics A total of 106 psoriasis patients were included, with mean disease duration of 14.5 years at index. Median age 47.9 years, 93% Caucasian, 67% male, 95% privately insured. Treatment history At index, 74% (n=78) of patients had received prior biologic therapy for psoriasis, predominantly with a TNF-α inhibitor (n=47), secukinumab (n=27) and/or ustekinumab (n=12). Approximately half had received prior systemic treatment (52%), such as methotrexate, and/or topical treatment (51%). Table 1. Disease severity (spga) at index and post-index time points for psoriasis patients treated with ixekizumab. spga score distribution (N=106) 1 1 month 2 (N=95) 1 3 months 3 (N=100) 1 6 months 3 (N=87) 1 9 months 3 (N=80) 1 12 months 3 (N=72) 1 0 Clear 3 (2.8) 28 (29.5) 53 (53.0) 41 (47.1) 40 (50.0) 28 (38.9) 1 Almost clear 5 (4.7) 28 (29.5) 21 (21.0) 8 (9.2) 17 (21.3) 17 (23.6) 2 Mild 20 (18.9) 31 (32.6) 15 (15.0) 23 (26.4) 10 (12.5) 17 (23.6) 3 Mild to moderate 12 (11.3) 1 (1.1) 2 (2.0) 3 (3.5) 2 (2.5) 2 (2.8) 4 Moderate 44 (41.5) 6 (6.3) 5 (5.0) 6 (6.9) 7 (8.8) 5 (6.9) 5 Moderate to severe 17 (16.0) 0 (0.0) 2 (2.0) 5 (5.8) 4 (5.0) 2 (2.8) 6 Severe 1 (0.9) 0 (0.0) 1 (1.0) 0 (0.0) 0 (0.0) 0 (0.0) Unknown 4 (3.8) 1 (1.1) 1 (1.0) 1 (1.2) 0 (0.0) 1 (1.4) Abbreviations: n=number; spga = Static physician global assessment.

4 Results (2) Table 2. Disease severity (BSA) at index and post-index time points for psoriasis patients treated with ixekizumab. BSA Distribution (N=106) 1 1 month 2 (N=95) 1 3 months 3 (N=100) 1 6 months 3 (N=87) 1 9 months 3 (N=80) 1 12 months 3 (N=72) 1 1 % (NPF T2T) 20 (18.9) 66 (69.5) 84 (84.0) 71 (81.6) 68 (85.0) 59 (81.9) <3% (Mild) 12 (11.3) 11 (11.6) 6 (6.0) 4 (4.6) 2 (2.5) 3 (4.2) 3%-10% (Moderate) 58 (54.7) 16 (16.8) 8 (8.0) 10 (11.5) 7 (8.8) 6 (8.3) >10% (Severe) 12 (11.3) 1 (1.1) 1 (1.0) 1 (1.2) 3 (3.8) 3 (4.2) Unknown 4 (3.8) 1 (1.1) 1 (1.0) 1 (1.2) 0 (0.0) 1 (1.4) Abbreviations: BSA=Body surface area; n=number; NPF T2T=National Psoriasis Foundation treat to target. Table 3. Health-related quality of life (DLQI) at index and post-index time points for psoriasis patients treated with ixekizumab. 1 month DLQI score 3 months 3 6 months 3 9 months 3 12 months 3 (N=106) (Effect on patient s life) (N=95) 1 (N=100) 1 (N=87) 1 (N=80) 1 (N=72) 1 0-1: No effect 22 (20.8) 53 (55.8) 67 (67.0) 51 (58.6) 48 (60.0) 48 (66.7) 2-5: Small effect 40 (37.7) 29 (30.5) 15 (15.0) 24 (27.6) 20 (25.0) 11 (15.3) 6-10: Moderate effect 21 (19.8) 9 (9.5) 9 (9.0) 8 (9.2) 7 (8.8) 6 (8.3) 11-20: Very large effect 14 (13.2) 4 (4.2) 7 (7.0) 4 (4.6) 4 (5.0) 5 (6.9) 21-30: Extremely large effect 5 (4.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Unknown 4 (3.8) 0 (0.0) 2 (2.0) 0 (0.0) 1 (1.3) 2 (2.8) Abbreviations: n=number; DLQI=Dermatology life quality index.

5 Results and Conclusions Results Speed of onset By 1 month (n=95, data available), more than half of patients (59%) had clear or almost clear skin (spga 0,1) and more than two-thirds (70%) had BSA 1%. By 3 months (n=100), nearly three-quarters of patients (74%) had spga 0,1, while 84% had BSA 1%. Duration of response At 12 months (n=72), 63% of patients had spga 0,1 and 82% had BSA 1%. At each time point, the median decrease from index was approximately 3% for BSA and about 2 points each for spga and DLQI scores (data not shown). IXE treatment continuation At 12 months, 74% (n=78) of patients in the cohort continued to receive treatment with ixekizumab (data not shown). Figure 1. Percentage of ixekizumab-treated psoriasis patients achieving target BSA ( 1%), spga (0,1), and DLQI (0,1) levels. Conclusions In this real-world cohort of IXE-treated psoriasis patients at a US dermatology referral practice, more than half of patients achieved clear skin (spga 0) at 3 months, and more than 80% met National Psoriasis Foundation (NPF) targets for BSA ( 1%) at 3 months and at every 6 month assessment. Improvements in disease severity (BSA, spga) and QoL (DLQI) were sustained over the first year of IXE treatment. Findings should be confirmed in larger multi-site studies. Disclosures: The study was sponsored by Eli Lilly and Company. Medical writing services were provided by ICON plc, and were funded by Eli Lilly and Company. C. Leonardi has received honoraria from Eli Lilly for the following: Advisory Board, Speaker, Consultant. AG, KO, SS, SW are employees of ICON plc., a company contracted by Eli Lilly to conduct this study. DA, MJM, C. Lin, and WNM are employees of Eli Lilly.