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Alternative Data Presentation For Treatment Outcomes in Psoriasis








Alternative Data Presentation For Treatment Outcomes in Psoriasis


Robert Gniadeki


University of Alberta, Faculty of Medicine & Dentistry, Division of Dermatology, Canada






7 Aug 2019


Modern patient care is built upon evidence-based medicine and relies on clinical trial data. However, traditional outcomes such as proportions of patients achieving a primary outcome lack clinical relevance for physicians. This project will investigate the usage of alternative methods of data analysis and presentation focusing on capturing individual patient outcomes, such as: waterfall plots and spider plots. We will also explore n-of-1 level analyses in psoriasis biologic clinical trials to further describe individualistic therapy outcomes and explore the possibility of designing smaller and more cost-efficient studies. We hypothesize these methods will provide more clinically relevant information and facilitate psoriasis treatment decisions for clinicians.



[{ "PostingID": 4450, "Title": "LILLY-I1F-MC-RHBL", "Description": "Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis UNCOVER-A" },{ "PostingID": 4451, "Title": "LILLY-I1F-MC-RHAJ", "Description": "A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis" },{ "PostingID": 4452, "Title": "LILLY-I1F-MC-RHAZ", "Description": "A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis UNCOVER-1" },{ "PostingID": 4453, "Title": "LILLY-I1F-MC-RHBA", "Description": "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis. UNCOVER-2" },{ "PostingID": 4454, "Title": "LILLY-I1F-MC-RHBC", "Description": "A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period UNCOVER-3" },{ "PostingID": 5059, "Title": "LILLY-I1F-MC-RHBS", "Description": "A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis (IXORA-S)" },{ "PostingID": 16102, "Title": "LILLY-I1F-MC-RHBE", "Description": "Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2." },{ "PostingID": 16125, "Title": "LILLY-I1F-MC-RHAP", "Description": "A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis (SPIRIT-P1)" },{ "PostingID": 16126, "Title": "LILLY-I1F-JE-RHAT", "Description": "A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis (UNCOVER-J)" },{ "PostingID": 16127, "Title": "LILLY-I1F-MC-RHBP", "Description": "A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis (IXORA-P)" },{ "PostingID": 19616, "Title": "LILLY-I1F-MC-RHBQ", "Description": "A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis (IXORA-Q)" }]

Statistical Analysis Plan