Bethesda, MD - August, 2006.
Lupus Foundation of America, Inc. (LFA), has awarded an LFA Research Grant to support Medical Technology and Practice Patterns Institute (MTPPI) in collaboration with Johns Hopkins School of Medicine to conduct the following study -"Relationship between Prednisone, Lupus Activity & Organ Failure: Exploratory Analysis study."Summary
Lupus is an autoimmune disease with serious, often life-threatening outcomes. The mainstay of treatment is corticosteroids, although they have serious side effects including fractures, coronary artery disease, cataracts, kidney failure, and other types of organ damage. Since both the treatment for lupus, and the lupus disease itself are both associated with organ damage, it has been difficult to isolate the role of the corticosteroids using traditional statistical techniques. Our exploratory study proposes to use innovative analysis techniques to find the causal relationship between corticosteroid therapy and organ damage among lupus patients. This research will provide a basis for improving current treatment, and potentially highlight the need to develop new steroid-sparing therapies.Scope and goal of LFA-funded grant
Our research effort will investigate the causal relationship between corticosteroid use and organ damage in patients with systemic lupus erythematosus (SLE) by combining advanced statistical techniques with existing clinical registry data. Specifically, we propose to examine the causal effects of cumulative corticosteroid dose and exposure to high-dose oral or intravenous corticosteroid regimens and organ damage among SLE patients enrolled in the Hopkins Lupus Cohort Study from 1987 to the present. Determining the causal pathways from the intervention using corticosteroids to the endpoint of organ damage is complex, particularly when using nonrandomized observational data. We intend to use an advanced statistical technique known as a Marginal Structural Model (MSM) to determine the causal effect of the primary SLE treatment, corticosteroids on specific types of organ damage controlling for the role of SLE disease activity that also contributes to organ damage. A better understanding of the relationship between corticosteroid therapy, SLE disease activity, and organ damage will hopefully provide a basis for improving current treatment guidelines for SLE, and potentially highlight the need to develop steroid-sparing therapies.Consortium Partners
Dr. Mae Thamer is the lead researcher from MTPPI, a nonprofit organization established in 1986 to conduct research on the clinical, economic, and social implications of new and emerging health care technologies. MTPPI's research is directed toward the formulation of health care policies. For more information on this project or MTPPI: www.mtppi.org. Dr. Michele Petri, the lead researcher from Johns Hopkins School of Medicine maintains the Hopkins Lupus Cohort Study, a prospective longitudinal study of lupus activity, organ damage, and quality of life in SLE patients that have been evaluated by Dr. Petri since 1987. Dr. Miguel Hernan, from the Harvard School of Public Health, is an authority on causal modeling and will work closely with MTPPI staff in this research project.