SOURCE: SUNY Downstate Medical Center

November 23, 2005 20:21 ET

Research Published in the New England Journal of Medicine Challenges 30-Year-Old Standard of Care for Lupus Patients

New Use for Immunosuppressive Drug Offers Hope, Quality of Life to Patients With Lupus Kidney Disease

NEW YORK, NY -- (MARKET WIRE) -- November 23, 2005 -- A promising new treatment for lupus challenges the way physicians currently treat patients suffering with lupus kidney disease, according to researchers at the State University of New York (SUNY) Downstate Medical Center.

A study published in the New England Journal of Medicine (NEJM) this week shows promising results of the use of mycophenolate mofetil (MMF), an immunosuppressive drug used primarily to combat organ rejection in transplant patients, in induction therapy for patients suffering from lupus nephritis (lupus kidney disease).

Marketed as CellCept®, which is approved by the U.S. Food and Drug Administration (FDA) for use in kidney, heart and liver organ transplant patients, MMF has been shown to play a major role in controlling lupus nephritis. The research published in NEJM found that lupus patients using orally administered MMF demonstrated better clinical response and did not experience many of the severe side effects associated with the current standard-of-care, intravenous cyclophosphamide (IVC), a form of chemotherapy, which has been used to treat patients with lupus kidney disease since the 1970s.

For patients and physicians, these landmark findings offer a choice. "With no FDA-approved drugs for the treatment of lupus nephritis for the past 30 years, we have been limited in our options for patients," said Ellen Ginzler, M.D., Professor of Medicine and Chief of Rheumatology, SUNY Downstate, Brooklyn, NY, and lead investigator in the study. "For some patients, the side effects associated with intravenous cyclophosphamide treatment have been worse than the disease itself."

The side effects of IVC therapy include nausea, vomiting, hair loss and infertility. Some patients, discouraged by these side effects, choose to forego treatment, putting themselves at risk for kidney failure and premature death.

Significant findings of the study include:

-- Induction therapy with MMF was superior to IVC in inducing complete
   remission of lupus nephritis

-- MMF appeared to be better tolerated than IVC, with less severe
   side effects

"These findings give us renewed confidence in treating lupus kidney disease and helping patients maintain their quality of life," said Sandra Raymond, president and CEO of the Lupus Foundation of America, the nation's leading non-profit organization for lupus. "This is encouraging news for the millions around the world who are suffering from the devastating effects of lupus."

Study Design

The NEJM report details the results of a 24-week randomized, open-label study of 140 patients at 19 study sites with systemic lupus erythematosus who had advanced stages of lupus nephritis. Investigators compared the effectiveness of an oral dose of MMF as induction therapy to that of the IVC treatment. At the start of the study, 71 patients received MMF and 69 patients received IVC; patients failing to improve in at least one key area after 12 weeks were converted to the other regimen. A total of 24 patients were withdrawn from the study; nine in the MMF group and 15 in the IVC group. There were 16 complete remissions; that is, the disease became inactive, on MMF and four complete remissions on IVC; 21 partial remissions, or improvement in the still active disease, were recorded in patients on MMF and 17 in patients on IVC.

Adverse Events

There were two deaths in the IVC group during treatment; a third patient declined IVC therapy and died from pulmonary hemorrhage and renal failure. There were no deaths in the MMF group. Infection and gastrointestinal side effects accounted for most of the adverse events in both patient groups. Severe infections (e.g., pneumonia and lung abscess, necrotizing fasciitis, gram-negative sepsis) occurred only in the IVC group. Pyogenic, or pus-producing, infections were significantly less frequent among patients receiving MMF. Hospitalizations for vomiting and dehydration occurred in five patients receiving IVC. Diarrhea occurred more frequently among patients in the MMF group.

About Lupus and Lupus Nephritis

According to the Lupus Foundation of America, it is estimated that as many as 1.5 million Americans suffer from lupus, a chronic autoimmune disease that causes inflammation and tissue damage to virtually any organ system in the body, especially the kidneys. Although lupus can strike in men and women of all ages, lupus occurs 10 to 15 times more frequently in women. Symptoms vary and the cause of lupus is not well understood, though researchers cite a combination of genetics and environment as possible factors. Lupus nephritis is a medical term for lupus that affects the kidneys. It is the most common severe complication of lupus and affects approximately one third of lupus patients.

For more information about lupus, please contact the Lupus Foundation of America at 202-349-1155 or visit the organization's website: www.lupus.org.

About SUNY Downstate Medical Center

SUNY Downstate Medical Center is the only academic medical center in Brooklyn, Queens, or Staten Island, comprising a College of Medicine, a College of Nursing, a College of Health Related Professions, a School of Graduate Studies, and University Hospital of Brooklyn.

About the Lupus Foundation of America

The Lupus Foundation of America is the nation's leading nonprofit voluntary health organization dedicated to lupus. The LFA has a nationwide network of nearly 300 chapters, branches and support groups located throughout the United States. The National Office is located in Washington, D.C.

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