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STEROID-FREE IMMUNOSUPPRESSION IN RENAL TRANSPLANTATION: A LONG-TERM FOLLOW-UP OF 100 CONSECUTIVE PATIENTS

Background. Our goal in clinical renal transplantation is to establish a steroid-free immunosuppressive protocol that not only promotes long-term patient and graft survival, but also improves the overall well-being of the patients. Methods. In a prospective, nonrandomized, clinical study 100 consecutive patients transplanted with first and second grafts were discharged from our center with functioning grafts 1996–1999 and followed for up to 41/2 years. Patients received steroid-free immunosuppression with an initial 10-day antithymocyte (ATG) induction and maintenance therapy with cyclosporine (CsA) and mycophenolate mofetil (MMF). No steroids were given. Results. After an observation time of up to 41/2 years, 1-, 2-, 3-, and 4-year graft survivals of 97, 96, 90, and 82% were observed, with no correlation to HLA-matching, kidney disease, donor age or type, or number of transplants. Ninety-nine patients (1 died or peritonitis after returning to dialysis) were alive and well. Ninety grafts were functioning well, 9 patients returned to dialysis due to recurrence of hemolytic uremic syndrome, and glomerulonephritis in 2 and chronic rejection in 7 grafts after 7–36 months (3 due to non-compliance after 7–30 months). All 7 children below the age of 15 are alive, with well-functioning grafts, except 1 with recurrence of glomerulonephritis who returned to dialysis after 21/2 years. There were 13 acute rejections (13%), 10 early (first 3 months) (10%), and 3 late (6–42 months) (3%). All acute rejection episodes were successfully reversed. No lymphomas were observed. Conclusions. Our first-line, steroid-free immunosuppressive protocol allows initial graft function, provides a safe level of long-term graft survival and function with a very low rejection rate, gives an acceptable rate of side effects, and possesses the potential for lowering the incidence of chronic rejection over the long-term. Compared with protocols that discontinue steroids after the initial posttransplant period, a steroid-free protocol avoids the increased risk of infection, body disfigurement, and other steroid-induced side-effects in the early posttransplant period. It also avoids the long-term risks of steroid use and the increased risk of rejection when the steriods are withdrawn. Much effort has been made to diminishing, withdrawing, or completely avoiding the use of glucocorticoids in clinical transplantation because of the many severe side effects (1,2). This report [an update of Birkeland (3)] describes the results of a prospective, nonrandomized, clinical study of 100 consecutive patients receiving first and second kidney transplants who were discharged from our department with a functioning graft between 1996 and 1999. Patients were treated with antithymocyte globulin, cyclosporine, and mycophenolate mofetil (ATG/CsA/MMF) with no use of steroid induction, maintenance, or conversions to other protocols and followed for up to 4.5 years.