Using Patient-Level Data from Psoriasis Clinical Trials to Evaluate the Relationship between Changes in Skin and Nail Psoriasis

Lead Investigator: Martin Okun, Fort HealthCare
Title of Proposal Research: Using Patient-Level Data from Psoriasis Clinical Trials to Evaluate the Relationship between Changes in Skin and Nail Psoriasis
Vivli Data Request: 9824
Funding Source: None
Potential Conflicts of Interest: Consultant for AbbVie, Azora Therapeutics, Bluefin Biomedicine, Boehringer Ingelheim, Incyte, Novartis, Phoenicis, Regeneron, Vyne Therapeutics.
These potential conflicts of interest will be managed by not sharing any non-public information accessed through Vivli, or information derived from analysis of non-public information accessed through Vivli, with any of the companies with which I consult.
Any conflicts of interest will be declared in any publication arising from the research.

Summary of the Proposed Research:

Psoriasis is a chronic (long-lasting) disease in which skin cells grow too quickly. Patches of skin become rough and red, most often on the scalp, elbows, or knees, but in other parts of the body also. About half of patients with psoriasis have psoriasis in their nails (nail psoriasis). Nail psoriasis changes fingernails and toenails, causing pitting, whitening, bleeding, discoloration, dryness, thickening of the skin beneath the nail, loosening, separation, and crumbling. About 11 million people in the United States have psoriasis, and about 4.7 million people in the United States have nail psoriasis. Nobody knows why only some patients with psoriasis get nail psoriasis, nobody knows why some patients have mild skin psoriasis and severe nail psoriasis (or the other way around), and nobody knows whether all medicines that improve skin psoriasis also improve nail psoriasis. In other words, nobody knows how closely these different types of psoriasis are connected.

Systemic therapies are treatments using substances that travel through the bloodstream, reaching and affecting cells all over the body. There are many systemic therapies that improve skin psoriasis and nail psoriasis. We want to learn if, when skin psoriasis improves, is it possible to predict how much nail psoriasis will improve no matter what type of systemic therapy is used. The other possibility is that some types of systemic therapy work better for skin psoriasis than nail psoriasis, or the other way around. The value of learning the answer is that it may help health care providers and psoriasis patients decide which systemic therapy to choose, in part based on how bad the skin and nail psoriasis is in each individual.

We will look at data from studies comparing two different systemic therapies. For each patient with skin and nail psoriasis, we will see how much each therapy improved skin psoriasis, and how much each therapy improved nail psoriasis. We will check if how much skin psoriasis and nail psoriasis improved was different between the two therapies.

Requested Studies:

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 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