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CellCept not superior to azathioprine in MAINTAIN Nephritis Trial
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After 10 years of follow-up, CellCept was not shown to be superior to azathioprine for the treatment of lupus nephritis in the MAINTAIN Nephritis Trial, according to recently published data.
Researchers reviewed data pertaining to survival, kidney function, 24-hour proteinuria, renal flares and other outcomes for 105 patients with systemic lupus erythematosus (SLE) who showed glomerulonephritis on biopsy and were enrolled in and randomly assigned to a treatment group within the MAINTAIN Nephritis Trial between July 2002 and March 2006.
On days 1 through 3, all patients had received pulse treatment of 750mg intravenous methylprednisolone followed by 0.5 mg per kg of body weight oral, prednisolone equivalent glucocorticoids for 4 weeks, which were tapered to by 2.5 mg equivalent prednisolone dose every 2 weeks. At week 24, the target was 7.5 mg per day and 5 mg at week 52. After week 76, glucocorticoids were stopped, if possible, or further tapered, and treatment with cyclophosphamide and either CellCept (mycophenolate mofetil, Roche) or azathioprine was initiated.
All patients received six 500-mg doses of cyclophosphamide every 2 weeks during a 10-week period. At week 12, patients were randomly assigned to either mycophenolate mofetil or azathioprine. The target dose of azathioprine was 2 mg per kg of body weight per day, and the target dose of mycophenolate mofetil was 2 g per day for 5 years if efficacious and tolerated, with the choice to continue at the discretion of the patient and physician after 5 years. Patients with nephrotic-range proteinuria were required to take ACE inhibitors, which were encouraged as treatment for other patients.
During the trial, five patients died and 13 were lost to follow-up. Four of the deaths were due to sepsis and one to complications from SLE. No differences were seen in the baseline characteristics of patients lost to follow-up vs. patients who remained in the study, according to the researchers.
Mean serum creatinine was 0.85 mg/dL in patients on either therapy, and similar numbers of patients experienced renal flares and at similar rates of time. No statistically significant difference was seen with serum creatinine levels at the last follow-up.
At 10 years after diagnosis, more than half of patients remained on low doses of glucocorticoids, and about one-third of patients assigned to either mycophenolate mofetil or azathioprine continued treatment after 5 years at mean daily dose of 1.8 g or 95 mg, respectively. Switching from either mycophenolate mofetil or azathioprine occurred in about 20% of patients taking azathioprine and 14% of patients taking mycophenolate mofetil. Severe adverse events numbered similarly between groups, and a similar number of successful pregnancies were recorded in each group, according to the researchers. - by Shirley Pulawski
Disclosure: The researchers report no relevant financial disclosures.
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