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Proposal 1430

Title of the Proposed Research

Comparison of various remission criteria for SLE. A study based on the BLISS-52 and BLISS-76 clinical trials.

Lead Researcher

Ronald van Vollenhoven

Affiliation

Department of Medicine, Solna

Funding Source

Unrestricted grant for treat to target remission definitions.

Potential Conflicts of Interest

None

Data Sharing Agreement Date

19 August 2016

Lay Summary

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that can affect almost any organ and can cause many different symptoms. In the last decades the treatments have gotten better but people who have SLE are still at considerable risk to develop complications and may even die earlier because of the disease. The disease makes the patients feel tired and listless (malaise) and may cause damage to the internal organs in some cases. The patients often need to be treated with medications such as steroids and drugs that fight the immune system, which may cause additional problems. International experts agree that the goals of the treatment for SLE must be to have the disease be completely under control, which is called “remission”. Even if the patient is not completely cured that would still be a very good result.

However, this concept of “remission” needs a clear definition so that people know exactly what is meant when they use the term: we need a definition of remission. For this reason, we gathered an international task force with patients and specialists to achieve agreement on a definition of remission in SLE, called DORIS—Definition Of Remission In SLE. This task force agreed that remission in SLE can be described as a desirable disease state for patients with, at the very least, the absence of major symptoms and signs of SLE, and has proposed several definitions of remission in SLE. In this study, we would like to use data from two previously done studies, called BLISS-52 and BLISS-76, and examine how the definitions of remissions that were proposed by the DORIS task force work out. We will calculate how many patients fulfill these definitions at how many time points; how stable this is in the individual patient; how it relates to other aspects of the disease; and we will see if patients who have a remission using the DORIS-definitions, have less problems with their SLE disease such as flare-ups of the disease, damage the internal organs, and a better quality of life.

Study Data Provided

Study GSK-HGS1006-C1056: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)
Study GSK-HGS1006-C1057: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.