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New use for immunosuppressive drug offers hope, quality of life to patients
with lupus kidney disease
NEW YORK, Nov. 23 /PRNewswire/ -- 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(R), 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 nations
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 organizations website: http://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 nations 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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