Rescue therapy with mycophenolate mofetil. The Mycophenolate Mofetil Renal Refractory Rejection Study Group.

Research with human transplant recipients has shown that mycophenolate mofetil (MMF) is a powerful and selective immunosuppressant for maintenance therapy following renal transplantation. An additional body of work suggests that it might also be a valuable tool for arresting ongoing rejection episodes. One randomized, open-label, multicenter study has compared the efficacy and safety of MMF administered with cyclosporine and maintenance corticosteroids versus high-dose intravenous corticosteroids (i.v. steroids) and conventional triple therapy, over a 6-month postenrollment period, for the treatment of refractory acute cellular renal allograft rejection. Treatment with MMF resulted in a 45% reduction in graft loss and death by 6 months postenrollment. (The number of deaths were the same in both treatment groups during the 6-month postenrollment period.) Treatment with MMF also significantly reduced the risk of experiencing a subsequent biopsy-proven rejection episode or treatment failure by almost 50%. The number of patients receiving one or more full courses of antilymphocyte therapy for a rejection episode subsequent to enrollment was more than twofold greater in the i.v. steroid group compared with the MMF group. Overall, and in most of the body systems, more adverse events were reported for patients in the MMF group, but the overall benefit-risk ratio for MMF supports its use with cyclosporine and maintenance corticosteroids for the treatment of refractory acute cellular renal allograft rejection.