Journal of Clinical and Aesthetic Dermatology

MauiDerm 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S15 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) r eported experience of IXE delivered v ia auto-injector. Methods: This was an analysis of the 12-week, open-label period of a Phase 3 trial in patients with moderate-to- severe psoriasis who were randomly assigned to an injection device (auto- injector or prefilled syringe). Presented h ere are analyses of the patients in the auto-injector group. The starting dose of IXE was 160mg at Week 0, followed by 80mg every two weeks. Patients or caregivers reported their experiences injecting with the auto-injector at Weeks 0, 4, and 8 using the Subcutaneous Administration Assessment Questionnaire (SQAAQ), a 12-item questionnaire that provides an assessment of ease of use and confidence using a device to administer a subcutaneous injection of drug using a 7-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree." Observed data are reported. Results: Of the 102 patients in the auto-injector group, 94 completed the 12-week period. At Week 0, over 90 percent of patients/caregivers agreed/strongly agreed with each of the items on the SQAAQ, and at Week 8 over 95 percent agreed or strongly agreed with each item. Among the items, over 90 percent of patients/caregivers reported that they agreed/strongly agreed that the auto- injector was "overall, easy to use," "easy to learn how to use," and that they were "confident my dose is complete" based on SQAAQ responses at Weeks 0, 4, and 8. Overall, the safety and efficacy profile was consistent with what has previously been reported. There were no serious adverse events or discontinuations associated with using the device. Mean percent improvement in PASI at Week 12 was 88 percent (LOCF). Conclusion: The vast majority of patients and caregivers who used the a uto-injector reported on the SQAAQ q uestionnaire that the device was overall easy to use and that they were confident in using the device when using it for the first time at Week 0. IXE delivered via an auto-injector had similar efficacy and safety findings as observed in the clinical trials for i xekizumab. Financial diclosures/funding: The study was sponsored by Eli Lilly and Company. Efficacy and Safety of Continuous Ixekizumab Treatment for 60 Weeks in Moderate-to-Severe Plaque Psoriasis: Results from the UNCOVER-3 Trial Presenters: Andrew Blauvelt, 1 Kim A. Papp, 2 Richard G. Langley, 3 Thomas Luger, 4 Mamitaro Ohtsuki, 5 Craig L. Leonardi, 6 Kristian Reich, 7 Lu Zhang, 8 Susan Ball, 8 Kenneth B. Gordon 9 Affiliations: 1 Oregon Medical Research Center, Portland, OR; 2 K. Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada; 3 Department of Medicine, Division of Dermatology, Dalhousie University, Halifax, NS, Canada; 4 Department of Dermatology, University of Münster, Münster, Germany; 5 Department of Dermatology, Jichi Medical University, Shimotsuke- shi, Japan; 6 Department of Dermatology, Saint Louis University School of Medicine, St. Louis, MO; 7 SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany; 8 Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN; 9 Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL Introduction: To describe the 60- week efficacy and safety of continuous ixekizumab (a high-affinity monoclonal antibody that selectively targets interleukin-17A [IL-17A]) treatment in p atients with moderate-to-severe p laque psoriasis. Methods: UNCOVER-3 is a Phase 3, placebo- and active-controlled trial in which patients were randomized in an induction period to placebo (N=193), etanercept 50mg twice weekly (N=382), or 80mg ixekizumab e very four weeks (N=386) or two weeks (N=385) after an initial 160mg starting dose. After 12 weeks, all patients entered into open-label treatment with IXE Q4W. Disease severity was assessed using the static Physician Global Assessment (sPGA) and Psoriasis Area Severity Index (PASI). Data from patients continuously treated with ixekizumab from Week 0 to Week 60 were summarized using descriptive statistics with nonresponder imputation for missing data. Results: At Week 12, 722 ixekizumab-treated patients continued with open-label Q4W treatment. At Week 60, the PASI 75, 90, and 100 response rates were 87, 78, and 57 percent, respectively, and sPGA 0,1 (complete clearance or minimal severity) response rate was 79 percent. The long-term safety and tolerability profile was similar to the induction period. 1 Conclusion: Continuous ixekizumab therapy over 60 weeks was highly efficacious and well-tolerated in treating plaque psoriasis. Financial diclosures/funding: This study was sponsored by Eli Lilly and Company. Secukinumab Treatment Provides Faster and More Effective Relief From Patient-reported Quality of Life Impact than Ustekinumab in Subjects with Moderate to Severe Plaque Psoriasis Presenters: Blauvelt A, 1 Korman N, 2 Mollon P, 3 Zhao Y, 4 Milutinovic M, 3 You

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