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Fluids & Electrolytes
WEDNESDAY, Nov. 16 (HealthDay News) -- For patients with lupus nephritis who have a clinical response to induction therapy, mycophenolate mofetil is superior to azathioprine for maintaining a renal response to treatment and preventing relapse, according to a study published in the Nov. 17 issue of the New England Journal of Medicine.
Mary Anne Dooley, M.D., M.P.H., from the University of North Carolina in Chapel Hill, and colleagues compared mycophenolate mofetil with azathioprine for maintenance therapy in 227 patients with lupus nephritis who had a clinical response during a six-month induction trial. Patients were enrolled into a 36-month randomized phase 3 study, and were assigned in a 1:1 ratio to receive mycophenolate mofetil (116 patients) or azathioprine (111 patients). Time to treatment failure, time to individual components of treatment failure (end-stage renal disease, doubled serum creatinine level, renal flare, rescue therapy), and adverse events were evaluated.
The investigators found that mycophenolate mofetil was significantly superior to azathioprine with respect to time to treatment failure, and time to renal flare and rescue therapy. The mycophenolate mofetil and azathioprine groups had observed treatment failure rates of 16.4 and 32.4 percent, respectively. More than 95 percent of patients in both groups suffered adverse events, most commonly minor infections and gastrointestinal disorders. Serious adverse events occurred in 33.3 and 23.5 percent of patients on azathioprine and mycophenolate mofetil, respectively. Patients on azathioprine had significantly higher adverse event-related withdrawal rates than those on mycophenolate mofetil therapy.
"Mycophenolate mofetil was superior to azathioprine in maintaining a renal response to treatment and in preventing relapse in patients with lupus nephritis," the authors write.
The study was supported by Vifor Pharma; several authors disclosed financial relationships with pharmaceutical companies, including Vifor.
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