Lead Investigator: John Reynolds, University of Birmingham
Title of Proposal Research: Patterns of skin flare in patients with systemic lupus erythematosus
Vivli Data Request: 8591
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Systemic lupus erythematosus (SLE) is an uncommon autoimmune condition in which there can be inflammation in different parts of the body. The number of people affected by SLE varied between regions but is typically 25-75/100,000 people (i.e. 1 in 2000 people). Patients with lupus common have inflammation on the joints (arthritis), skin, or other major body organs (e.g. kidney). Skin inflammation (rash) is a common feature of SLE. Although some important causes of skin inflammation have been identified (e.g., exposure to UV light), we still are not able to reliably predict which patients may be more likely to have a flare in their skin or be less likely to respond to conventional treatments. As the skin is the largest organ in the body, it is also important to consider which part of the skin in inflamed; we propose that sites that have been inflamed previously may be more likely to flare again. To investigate this and to identify factors which are associated with new skin flare or persistent skin inflammation we plan to use data from 3 clinical trials in patients with SLE. We will use data from the standard of care arm (routine treatment) to compare patients who have skin inflammation that improves to those that have persistent inflammation. We will also study patient who develop new skin inflammation to try to identify patient factors (such and antibodies, medication, other lupus features) that can predict which patients will develop skin inflammation. Finally, we will use a detailed skin assessment score to understand whether patients who have active skin disease at the start of the trial are more or less likely to have a future flare at the same site. These studies will help us to better identify lupus patients at risk of skin disease, those who are less likely to respond to conventional treatment and to understand whether future studies should focus on changes that occur in the skin during inflammation that may increase the risk of future skin flare.
Requested Studies:
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Data Contributor: AstraZeneca
Study ID: NCT02446899
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Data Contributor: AstraZeneca
Study ID: NCT02446912
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
Data Contributor: AstraZeneca
Study ID: NCT01438489