MYCOPHENOLATE MOFETIL FOR THE TREATMENT OF A FIRST ACUTE RENAL-ALLOGRAFT REJECTION

Background, Mycophenolate mofetil (MMF) significantly reduces the inci dence of acute allograft rejection in renal transplant patients, The e ffect of adding MMF to the immunosuppressive regimen of patients with established rejection is unknown, The purpose of the current study was to compare the safety and efficacy of the addition of MMF to the trea tment regimen of an early first acute cellular rejection, Methods, The study was a double-blind, double-dummy controlled clinical trial of 2 21 renal transplant recipients experiencing the first biopsy-proven re jection within 6 months of transplant performed at 15 U.S. and Canadia n centers. A total of 113 patients received MMF (1.5 g twice daily) an d intravenous corticosteroids, and 108 patients received azathioprine (AZA) (1-2 mg/kg/day) and intravenous corticosteroids. The intravenous corticosteroids in each group consisted of 5 mg/kg/day for 5 days fol lowed by an oral steroid taper. End points for the study were the firs t use of antilymphocyte therapy, the number of courses of antirejectio n therapy given during the first 6 months, and graft and patient survi val at 1 year, Results, At 6 months, 16.8% of the MMF-treated patients and 41.7% of the AZA-treated patients required at least one course of antilymphocyte therapy (P<0.0001), The number of patients requiring f ull courses of antirejection therapy for the treatment of rejection wa s less in the MMF-treated group (24.8%) versus the AZA-treated group ( 58.3%) (P<0.0001). The proportion of patients with the use of antilymp hocyte therapy or treatment failure during the first 6 months was 29.2 % vs. 51.9% (P=0.0006) in the MMF versus the AZA groups, respectively, By 1 year after enrollment, 10 patients (8.9%) in the MMF-treated gro up lost their graft or died versus 16 patients (14.8%) in the AZA-trea ted group. More patients in the MMF group withdrew because of an adver se event: 20 patients (17.7%) compared with 11 AZA-treated patients (1 0.2%). Conclusions. MMF administered in combination with pulse cortico steroids significantly decreases the subsequent use of antilymphocyte therapy in the treatment of acute renal allograft rejection, In additi on to being a safe and effective prophylactic agent, MMF added to ster oids improves the rate of reversal of acute rejection episodes.