September 2, 2007
Systemic Lupus Erythematosus (SLE) or Lupus as it is commonly referred to, is an autoimmune disease of unknown cause that affects many different organ systems and has a great variety of clinical manifestations.
The disease disproportionately affects women of child-bearing years and minorities (eg, blacks, Hispanics and Asians). The diagnosis requires specific blood tests and sometimes tissue biopsies, and it appears that a nearly universal component to the disease is the presence of specific antibodies to nuclear components suggesting that something has caused the immune system to become dysregulated.
The progression of SLE may vary from mild episodes to severe, even fatal outcomes with symptoms varying widely in individuals over time. The course of the disease is very variable, with periods of remission (few symptoms) and flares (return of symptoms and possible worsening of the disease). SLE can affect the skin (rash), musculoskeletal (muscles and bones) system (arthritis, bone tissue death), nervous system (seizures, psychosis), lungs (pleuritis, pneumonitis), and the blood (veneous or arterial clots, anemia). In addition, approximately 65% of patients will develop Lupus Nephritis, which is an inflammation of the kidney that can range from a mild condition (called glomerulonephritis) to a severe condition (called diffuse proliferative glomerulonephritis). Some patients may even undergo kidney failure as a serious complication of SLE at some point during their illness.
Two studies are underway at the NYU Bluestone Center for Clinical Research to investigate the effectiveness of novel therapies for SLE (systemic lupus erythematosus) or Lupus.
One study is for SLE patients with Lupus Nephritis. NYU’s Lupus experts are testing an already approved FDA drug for this condition. The drug is currently FDA approved and is used frequently for certain cancers, and patients with autoimmune diseases (rheumatoid arthritis and multiple sclerosis). It will be tested at NYU specifically for patients with Lupus Nephritis. It is believed that the drug will help not only with the treatment of Lupus Nephritis, but also in the general treatment of Lupus.
A second study is for SLE patients and will be testing a novel drug given either subcutaneously (SC) or intravenously (IV) to determine its safety and tolerability after single doses. The drug is anticipated to help control the production of certain immune-modifying factors that are contributing to the severity of the disease, and thereby diminish the symptoms of Lupus.
Subjects with moderate to severe Lupus (with or without Lupus Nephritis) may be eligible for either study. Please contact specialized clinical research coordinators at the Bluestone Center for Clinical Research at (212) 998-9310 for more information.