Results of pancreas transplantation after steroid withdrawal, under tacrolimus immunosuppression

Purpose. The results of steroid withdrawal in pancreas transplant recipient s under tacrolimus immunosuppression were analyzed. Methods. From July 4, 1994 until April 30, 1998, 147 pancreas transplantati ons were performed in 141 patients, including 126 simultaneous pancreas-kid ney transplantations, 13 pancreas after kidney transplantation, and 8 pancr eas transplantations alone. Baseline immunosuppression consisted of tacroli mus and steroids without antilymphocyte induction. Twenty-three patients we re excluded from analysis because of early graft loss in 17 cases, retransp lantation in 5 cases, and simultaneous pancreas-kidney transplantation afte r heart transplantation in 1 patient. Results. With a mean follow-up of 2.8+/-1.1 years (range 1.0 to 4.8 years), complete steroid withdrawal was achieved in 58 (47%) patients with a mean time to steroid withdrawal of 15.2+/-8 months (range 4 to 40 months after t ransplantation). Of the entire cohort of 141 patients, overall 1-, 2-, and 4-year patient survival rates were 98%, 95.5%, and 86%, respectively. Overa ll 1-, 2-, and 4-year graft survival rates were 83%, 80%, and 71% (pancreas ) and 95%, 91%, and 84% (kidney), respectively. Of the 124 patients analyze d for steroid withdrawal, 1-, 2-, and 4-year patient survival rates were 98 %, 97%, and 92%, respectively. Overall 1-, 2-, and 4-year graft survival ra tes were 98%, 91.5%, 83% (pancreas) and 97%, 95%, and 91% (kidney). Patient , pancreas, and kidney survival rates at 1 year were 100%, 100%, and 98% (o ff steroids) versus 97%, 91%, and 96% (on steroids, all NS) and at 4 years were 100%, 94%, and 95% (off steroids) versus 78%, 68%, and 85% (on steroid s, P=0.01, 0.002, and NS, respectively). The cumulative risk of rejection a t the time of follow-up was 76% for patients on steroids versus 74% for pat ients off steroids (P=NS). Seven patients originally tapered off steroids w ere treated for subsequent rejection episodes, which were all steroid sensi tive, and two of these seven patients are currently off steroids. Thirteen patients received antilymphocyte therapy for steroid-resistant rejection, f ive of whom are now off steroids. Tacrolimus trough levels were 9.3+/-2.4 n g/ml (off steroids) and 9.7+/-4.3 (on steroids, P=NS). Mean fasting glucose levels were 98+/-34 mg/dl (off steroids) and 110+/-41 mg/dl (on steroids, P=NS). Mean glycosylated hemoglobin levels were 5.2+/-0.9% (off steroids) a nd 6.2+/-2.1% (on steroids, P=0.02), and mean serum creatinine levels were 1.4+/-0.8 mg/dl (off steroids) and 1.7+/-1.0 mg/dl (on steroids, P=0.02). Conclusion. These data show for the first time that steroid withdrawal can be safely accomplished in pancreas transplant recipients maintained on tacr olimus-based immunosuppression. Steroid withdrawal is associated with excel lent patient and graft survival with no increase in the cumulative risk of rejection.