Cellcept and lupus nephritis
by Nathan Wei, MD, FACP, FACR
Nathan Wei is a nationally known board-certified rheumatologist and author of the Second Opinion Arthritis Treatment Kit. It's available exclusively at this website... not available in stores.
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Lupus nephritis is an inflammatory kidney disorder that is a complication of systemic lupus erythematosus (SLE).
It is characterized by progressive loss of kidney function.
Lupus nephritis is one of the most dreaded complications of SLE and increases the morbidity and mortality associated with the disease.
Patients with lupus nephritis who do not receive immunosuppressive treatment progress to chronic kidney failure.
Long-term or maintenance therapy with cyclophosphamide increases kidney survival in patients with lupus nephritis, but this drug has considerable toxicity including the development of malignancy.
There is some evidence in studies with rodents to suggest that either oral mycophenolate mofetil (CellCept) or azathioprine may be as effective as cyclophosphamide without the toxic side effects.
In a recent study and the accompanying editorial, (Sequential Therapies for Proliferative Lupus Nephritis, by Gabriel Contreras, M.D., M.P.H., Victoriano Pardo, M.D., Baudouin Leclercq, M.D., Oliver Lenz, M.D., Elaine Tozman, M.D., Patricia O'Nan, R.N., and David Roth, M.D.; The New England Journal of Medicine, March 4, 2004. Related Editorial, Maintenance Therapy for Lupus Nephritis - Something Old, Something New, by James E. Balow, M.D., and Howard A. Austin, III, M.D.), a comparison was made between two sequential regimens: (1)short-term intravenous cyclophosphamide followed by either oral CellCept or azathioprine, and (2)long-term therapy with intravenous cyclophosphamide.
A total of 59 (fifty-nine) patients with lupus nephritis participated in this study. Forty-six percent (46%) were black, 49% were Hispanic, and 5% were white. All of the participants received a maximum of 7 (seven) monthly injections of intravenous cyclophosphamide plus corticosteroids. Then, the patients were randomly assigned to one of three maintenance therapies for 1-3 years:
1. quarterly intravenous injections of cyclophosphamide,
2. oral azathioprine (1 to 3 mg per kilogram of body weight per day),
3. or oral CellCept (500 to 3000 mg per day).
The researchers measured the serum creatinine, blood urea nitrogen (BUN), albumin, and liver-enzyme levels of the participants first monthly and then quarterly. They also took a complete blood count, urinalysis, and measurement of protein and creatinine levels in 24-hour urine collections, and measured the antinuclear antibodies (ANA), etc. Over the 6-year period of the study, the researchers monitored the number of patient hospitalizations and the number of patients who died and/or had kidney failure.
Using data about patient and kidney survival and hospitalization rates, the researchers then performed statistical analyses to compare the outcomes among the 3 groups.
The authors found:
• short-term treatment with intravenous cyclophosphamide followed by maintenance therapy with either CellCept or azathioprine resulted in a lower rate of death or chronic kidney failure than did long-term therapy with intravenous cyclophosphamide,
• short-term administration of intravenous cyclophosphamide followed by maintenance therapy with either CellCept or azathioprine was safer than long-term therapy with intravenous cyclophosphamide. For example, the hospitalization rates were significantly lower in both the CellCept and azathioprine maintenance therapy groups than in the group given long-term intravenous cyclophosphamide,
• the incidence of severe infection was significantly lower in both the CellCept and azathioprine maintenance therapy groups than in the group given long-term intravenous cyclophosphamide.
The authors noted that their study showed that short-term therapy with intravenous cyclophosphamide followed by maintenance therapy with CellCept or azathioprine is more effective and safer than long-term therapy with intravenous cyclophosphamide for the treatment of lupus nephritis.
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