Steroid-free, tacrolimus-basiliximab immunosuppression in pediatric liver transplantation: Clinical and pharmacoeconomic study in 50 children

Abstract

Corticosteroid-free immunosuppression (IS) may be potentially beneficial for transplanted patients, particularly children. The purpose of this study was to evaluate the efficacy and cost of such strategy in primary pediatric liver transplantation (LT). Fifty pediatric LT recipients were prospectively treated with a steroid-free, tacrolimus-basiliximab-based IS (group TB). A group of 34 children transplanted under a conventional tacrolimus-steroids regimen served as control series (group TS). Groups TB and TS were compared regarding patient and graft survival, rejection incidence, infectious complications, and growth, as well as cost of the transplant procedure. Patient and graft survivals at 3 years were 96% and 94% in group TB, versus 91% and 88% in group TS (P ϭ 0.380 and P ϭ 0.370, respectively). Rejection-free graft survival at 3 years was 72% in group TB, versus 41% in group TS (P ϭ 0.007). Patients in group TB had significantly less viral infections than patients in group TS (P ϭ 0.045). Height standard deviation score was significantly enhanced in children from group TB, when compared to group TS. Medical care costs were similar in both groups. Steroid avoidance together with basiliximab immunoprophylaxis was not harmful in terms of allograft acceptance, and even seemed to be beneficial in the long term. Liver Transpl 14: [469][470][471][472][473][474][475][476][477] 2008. Corticosteroids have invariably been part of induction and maintenance immunosuppression (IS) since the early days of clinical liver transplantation (LT). 1,2 Despite the potential benefits to be expected from early withdrawal or even avoidance of steroid administration, steroid therapy is still combined with cyclosporine or tacrolimus in the vast majority of adult and pediatric LT recipients worldwide. 3,4 The putative advantages of a steroid-free IS protocol are of particular interest in children, and include the reduction of infectious complications, decrease of arterial blood pressure and blood cholesterol with reduced atherogenesis in the longterm, better glucose tolerance, reduced risk of cataracts, reduced incidence of osteopenia, and improved linear growth. [3][4][5] Moreover, as suggested in rodent models, the administration of steroids may interfere with the process of hepatic regeneration as well as with the development of immunologic tolerance. 6,7 In 2003, we published a proof-of-concept study evaluating the safety of a steroid-free, tacrolimus-basiliximab-based IS protocol in 20 pediatric LT recipients. 8 The benefits of tacrolimus and basiliximab-based IS at 1-year follow-up have been confirmed in a randomized study. 9 The aim of the present work was to evaluate the longterm (3 years) benefit of this protocol with respect to patient and graft survivals, rejection and infection

Steroid Avoidance in Pediatric Heart Transplantation Results in Excellent Graft Survival

“…Other explanations for the worse univariable outcomes in the MS group indude a higher proportion of African Americans, a higher proportion of patients who underwent transplantation in the earlier era, and a higher proportion of patients with a previous sternotomy, all of which have been associated with a higher risk of graft loss (1, 9, 10). The successful use of SF maintenance immunosuppression in our analysis is consistent with single-center and dual-center reports of SF maintenance immunosuppression in heart, liver, and renal transplantation (2, 3, 11, 12). While there are no other studies in pediatric HT directly comparing graft survival in patients with and without MS use, multiple single-center studies of pediatric HT have reported outcomes with an SF maintenance immunosuppression protocol with excellent results (2, 8, 13-16).…”

609 Steroid Avoidance in Pediatric Heart Transplantation Results in Excellent Graft Survival

“…Other explanations for the worse univariable outcomes in the MS group indude a higher proportion of African Americans, a higher proportion of patients who underwent transplantation in the earlier era, and a higher proportion of patients with a previous sternotomy, all of which have been associated with a higher risk of graft loss (1,9,10). The successful use of SF maintenance immunosuppression in our analysis is consistent with single-center and dual-center reports of SF maintenance immunosuppression in heart, liver, and renal transplantation (2,3,11,12). While there are no other studies in pediatric HT directly comparing graft survival in patients with and without MS use, multiple single-center studies of pediatric HT have reported outcomes with an SF maintenance immunosuppression protocol with excellent results (2,8,(13)(14)(15)(16).…”

Basiliximab as therapy for acute rejection after liver transplantation for hepatitis C virus cirrhosis

“…Anti-IL-2 receptor antibodies are now widely used in liver transplantation as induction agents targeted at reducing the incidence of ACR (2,17,18) or as a calcineurin-inhibitor (19) or steroid-sparing strategy (20,21) to protect renal function in the immediate postoperative period. Comparison of induction therapy (12) between antithymocyte globulin + cyclosporine + steroid + azathioprine and anti-IL-2 receptor antibody + tacrolimus + steroid + azathioprine demonstrated a reduced ACR incidence in the anti-IL-2 receptor antibody group (43% versus 29%; p < 0.01).…”