Efficacy and Safety of Basiliximab with a Tacrolimus-Based Regimen in Liver Transplant Recipients

Abstract

Background. Induction with monoclonal antibodies for prevention of acute cellular rejection (ACR) may avoid many of the adverse events associated with polyclonal antibodies. Basiliximab, a chimeric monoclonal antibody directed against the ␣-chain of the interleukin 2 receptor (CD25), has been extensively evaluated as an induction therapy for kidney transplant recipients, more frequently in combination with a cyclosporine-based regimen. In this study, we assessed the efficacy and safety of basiliximab in combination with a tacrolimus-based regimen after liver transplantation. Methods. Fifty consecutive liver transplants (47 cadaveric donors; 3 living donors) were analyzed. All patients received two 20-mg doses of basiliximab (days 0 and 4 after transplantation) followed by tacrolimus (0.15 mg/kg/day; 10 -15 ng/mL target trough levels) and a tapered dose regimen of steroids. Follow-up ranged from 404 to 1,364 days after transplantation (mean 799.89 days, SDϮ257.37; median 796 days). Results. A total of 88% of patients remained rejection-free during follow-up with an actuarial rejection-free probability of 75% within 3 months. The actuarial patient survival rate at 3 years was 88%, and the graft survival rate was 75%. Twelve (24%) patients experienced one episode of sepsis, requiring temporary reduction of immunosuppressive therapy. There were no immediate side effects associated with basiliximab and no evidence of cytomegalovirus infection or posttransplant lymphoproliferative disorder. Conclusions. Basiliximab in combination with a tacrolimus-based immunosuppressive regimen is effective in reducing episodes of ACR and increasing ACR-free survival after liver transplantation. In addition, basiliximab does not increase the incidence of adverse effects or infections.

Post-transplantation lymphoproliferative disorder in living-donor liver transplantation: a single-center experience

“…Although three pediatric patients received OKT3 for allograft rejection in our series, PTLD did not develop in any of them. Interestingly, induction therapy with anti-IL2 receptor antibody does not seem to be associated with an increased risk of PTLD [9,30,31]. At our institution, 48 adult and 3 pediatric recipients who underwent transplantation after December 2002 received induction therapy with anti-IL2 receptor antibody, and none of them suffered PTLD, which supports the safety of induction therapy with this antibody.…”

Anti-IL2 Induction in Liver Transplantation with 93% Rejection-Free Patient and Graft Survival at 18 Months

“…Although losses through ascitic fluid may account for about 20% of drug elimination, and more substantially in the presence of massive ascites, increased blood loss seen in liver transplantation has little contribution to drug clearance [20]. In conjunction with calcineurin inhibitors and steroids, basiliximab has been proven effective in reducing acute rejection with almost no side effects in OLT [9,10,12].…”

“…Experience with the use of basiliximab induction in liver transplantation is, however, less extensive than in kidney transplantation. Several published data demonstrated the efficacy and safety of anti-IL-2R induction in conjunction with dual (cyclosporine/tacrolimus and steroids) or triple (cyclosporine, azathioprine, and steroids) therapy in adult OLT recipients [9][10][11][12]. They noted lower mean ACR rates in the anti-IL-2R group compared to standard immunosuppression without anti-IL-2R (23% versus 41%, respectively), although the 1-year graft and patient survival rates were not significantly different.…”

Complications in Immunosuppressive Therapy of Liver Transplant Recipients

“…Recently, a meta-analysis of CS-free immunosuppression in LT was published, comprising 21 controlled randomized trials, with a total of more than 2500 patients, aimed at assessing the risks and benefits of this new strategy [2]. On the basis of this background, in May 2008, we decided to change our previous practice discontinuing the administration of CS as part of immunosuppressive regimen after LT [3,4]. Given that the rate and severity of LT recipient complications have been successfully determined, and studied using the multi-tier grading system developed by Clavien et al, we chose to implement it, in its last version, for our analysis [5,6].…”