Managing Lupus Patients
Systemic Lupus Erythematosus (SLE). Lupus is a highly variable chronic inflammatory autoimmune disorder in which antibodies are formed against the person's own body proteins or tissues and can involve a variety of organ systems. Lupus can cause severe joint and muscle pain, kidney failure, heart failure, psychosis, seizures, skin lesions and extreme exhaustion. As reported in the May 1998 issue of Arthritis & Rheumatism, lupus affects an estimated 239,000 people in the United States. Life expectancy for lupus patients has improved over the past three decades, but is still significantly shorter than the average for the U.S. population. The course of the disease is often unpredictable, with periods of increased activity, known as flares, alternating with clinical stability. The causes of most lupus flares are unknown.
We are currently in the discovery phase of the test development process, identifying gene candidates.
XDx recently initiated the Systemic Lupus Erythematosus Activity Gene Expression (SAGE) study. This is a large multi-center study designed to collect samples and data for developing a gene-expression test to monitor disease activity in individuals with systemic lupus erythematosus.
The goal of this study is to enable the study sponsor to develop a new blood test method for clinicians to accurately predict which individuals with lupus will flare, when the flare will occur, and flare severity. Ultimately such a newly derived test could possibly allow treating physicians to start pre-emptive therapy early, with the goal of achieving remission quickly and with a shorter duration of treatment; identify individuals who will have less severe flares and will thus require less aggressive treatments; or intensify and lengthen treatment for those individuals who will need such therapy.
The design of this study is to follow individuals with a known diagnosis of SLE for changes in disease activity during the course of one year of observation. Clinical data and blood and urine samples will be collected at scheduled monthly visits. The clinical data and blood samples will be used for identifying gene expression profile(s) that are associated with increases in SLE disease activity (lupus "flares"). To learn more about this trial, please visit clinicaltrials.gov