Outcome after steroid withdrawal in pediatric renal transplant patients receiving tacrolimus-based immunosuppression

Background. Corticosteroids have always been an integral part of immunosupp ressive regimens in renal transplantation. The primary goal of this analysi s was to assess the safety of steroid withdrawal in our pediatric renal tra nsplant recipients receiving tacrolimus-based immunosuppression. Methods. Between December 1989 and December 1996, 82 renal transplantations were performed in pediatric patients receiving tacrolimus-based immunosupp ression. Two of these patients lost their grafts within 3 weeks of transpla ntation (and were still on steroids at the time of graft loss), and were ex cluded from further analysis. Seventy-four patients (92.5%) were taken off prednisone a median of 5.7 months after transplantation. Of these 74, 56 (7 0%) remained off prednisone (OFF), and 18 (22.5%) were restarted on prednis one a median of 14.8 months after discontinuing steroids (OFF --> ON). 6(7. 5%) were never taken off prednisone (ON). The mean follow-up was 59+/-23 mo nths. Results. The 1-, 3-, and 5-year actuarial patient survival rates in the OFF group were 100%, 98%, and 96%, respectively; in the OFF --> ON group, they were 100%, 100%, and 100%, and in the ON group, they were 100%, 83%, and 8 3%. The 1-, 3-, and 5- year actuarial graft survival rates in the OFF group were 100%, 95%, and 82%, respectively; in the OFF --> ON group, they were 100%, 89%, and 83%; and in the ON group, they were 100%, 50%, and 33%. Two of the six graft losses in the OFF group, three out of four in the OFF --> ON Group, and two out of five in the ON group, were to chronic rejection. A time-dependent Cox regression analysis showed that the hazard for graft fa ilure for those who came and stayed off prednisone was 0.178 relative to th ose who were never withdrawn from prednisone (P=0.005). Patients who were 1 0 years of age or younger were withdrawn from prednisone earlier (median: 5 months) than those older than 10 years (median: 7.5 months, P=0.02). In ad dition, patients who never had acute rejection were withdrawn from steroids earlier (median: 5 months) than those who had one or more episodes of acut e rejection (median: 7.6 months, P=0.001). There was no effect of donor age , race, sex, recipient race, sex, cadaveric versus living donor, 48-hr graf t function, panel reactive antibody, and total HLA mismatches or matches on the likelihood of being weaned off steroids. Serum creatinine at most rece nt follow-up in the OFF group was 1.2+/-0.5 mg/dl; in the OFF a ON group, i t was 1.8+/-0.9 mg/dl, and in the ON group it was 2.0 mg/dl (P<0.003). The incidence of rejection in the OFF, OFF --> ON, and ON groups was 39%, 77%, and 100%, respectively (P<0.05). Conclusion. These data suggest that steroid withdrawal in pediatric renal t ransplant patients receiving tacrolimus-based immunosuppression is associat ed with reasonable short- and medium-term patient and graft survival, and a cceptable renal function. Patients who discontinue and then resume steroids had patient and graft survival rates comparable with those in patients who discontinue and stay off steroids, but had a higher serum creatinine and a higher incidence of rejection.