Efficacy and safety of basiliximab with a tacrolimus-based regimen in liver transplant recipients.
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 alpha-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, SD+/-257.37; 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.
Marino
Ignazio R
IR
Division of Liver Transplantation and Hepatobiliary Surgery, Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, PA 19107-5083, USA. ignazio.marino@jefferson.edu
Doria
Cataldo
C
Scott
Victor L
VL
Foglieni
Carlo Scotti
CS
Lauro
Augusto
A
Piazza
Tommaso
T
Cintorino
Davide
D
Gruttadauria
Salvatore
S
D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000077552:Basiliximab; D003586:Cytomegalovirus Infections / Q000517:prevention & control; D004359:Drug Therapy, Combination; D005260:Female; D006085:Graft Survival; D006525:Hepatitis, Viral, Human / Q000601:surgery; D006801:Humans; D008107:Liver Diseases / Q000145:classification / Q000601:surgery; D016031:Liver Transplantation / Q000276:immunology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*
D000911:Antibodies, Monoclonal; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D016559:Tacrolimus