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 4 1/2 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 4 1/2 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 2 1/2 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 It also avoids the long-term risks of steroid use and the increased risk of rejection when the steriods are withdrawn.