Lead Investigator: Emanual Maverakis, University of California Davis
Title of Proposal Research: Developing Efficacy Assessment Tools from Existing Psoriasis Clinical Trial Outcome Data
Vivli Data Request: 7317
Funding Source: Dr. Maverakis is funded through an NIH mid-career award, K24AR077313
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Psoriasis is an inflammatory skin disease that affects around 2-3% of the general population, with incidence reportedly on the rise. Patients with psoriasis also have an increased risk of other comorbidities, including cardiovascular disease, depression, and anxiety. In order for new drugs to be developed or the efficacy of one treatment to be compared to another, investigators need accurate tools to assess disease severity in psoriasis. This will allow them to determine how much the patient improves, and how fast they improve after starting a treatment.
We are requesting access to clinical trial raw datasets to study the relationships between the individual components of the various efficacy assessment tools used in psoriasis. Over the past decade, patient reported outcome measures have become an integral part of clinical trials, especially in the field of dermatology. In 2001, when results from the psoriasis alefacept study were published in the New England Journal of Medicine, the only assessment tools used were the “treating physician’s overall assessment”, a score ranging from 0 (clear) to 6 (severe disease), and the Psoriasis Area and Severity Index (PASI), which ranges from 0 (no disease) to 72 (maximum disease). This successful trial led to the first ever FDA-approved biologic therapy for psoriasis, alefacept. Notably, this trial lacked a patient-reported outcome measure, as they were not commonly utilized in psoriasis trials at the time. However, over the following decade, efficacy assessments have consistently incorporated additional tools. For example, in 2017, a trial of risankizumab versus ustekinumab for psoriasis published in the New England Journal of Medicine utilized 13 secondary efficacy endpoints in addition to PASI90, which was the primary endpoint. These secondary efficacy endpoints included several patient-reported outcome measures: patient’s assessment of itching (PAI), patient’s assessment of pain on a visual analogue scale (pain VAS), Dermatology Life Quality Index (DLQI), and EuroQol 5 dimensions (EQ-5D).
The ultimate goal is to develop improved tools or to simplify existing tools to assess disease severity in psoriasis. Such tools can then be used in the development of new treatments and prognostic models.
Requested Studies:
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
Data Contributor: Lilly
Study ID: NCT01646177
Sponsor ID: 13685
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
Data Contributor: Lilly
Study ID: NCT02718898
Sponsor ID: 16010
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
Data Contributor: Lilly
Study ID: NCT02561806
Sponsor ID: 16012
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
Data Contributor: Lilly
Study ID: NCT02513550
Sponsor ID: 15988
Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis
Data Contributor: Lilly
Study ID: NCT01777191
Sponsor ID: 14728
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
Data Contributor: Lilly
Study ID: NCT01695239
Sponsor ID: 13731
A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis
Data Contributor: Lilly
Study ID: NCT01624233
Sponsor ID: 13976
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
Data Contributor: Lilly
Study ID: NCT01597245
Sponsor ID: 12973
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
Data Contributor: Lilly
Study ID: NCT01474512
Sponsor ID: 12972
A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
Data Contributor: Lilly
Study ID: NCT01107457
Sponsor ID: 12060