Basiliximab in a triple-drug regimen with tacrolimus and steroids in liver transplantation.
BACKGROUND
Basiliximab, a chimeric monoclonal antibody (mAb) directed against the alpha chain of the interleukin-2 (IL-2) receptor (CD25), has been extensively evaluated as 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 tacrolimus and steroids following liver transplantation.


METHODS
One hundred fifty-two liver transplant recipients (141 cadaveric donors and 11 living donors [LRLT]) in the last 4 years were treated with 2 20-mg doses of basiliximab (days 0 and 4 posttransplantation) followed by tacrolimus (0.15 mg/kg/d; 10-15 ng/mL target trough levels) and steroids (500 mg intravenous [IV] bolus at the reperfusion followed by 20 mg orally daily and weaning off in 1 or 2 months). Follow-up ranged from 104 to 1630 days after transplantation (mean, 665 days; SD +/- 442.65; median, 509 days).


RESULTS
Eighty-five percent of patients remained rejection-free during follow-up with an actuarial rejection-free probability of 78% within 3 months. Nineteen patients had 22 episodes of biopsy-proven acute cellular rejection (ACR). Actuarial patient and graft survival rates at 3 years were 86.7% and 75.8%, respectively. Twenty-seven patients (20.6%) experienced 1 episode of sepsis, requiring temporary reduction of immunosuppressive therapy. There was no evidence of CMV infections or side effects related to basiliximab. We observed 2 de novo malignancies, 1 recurrence from an ileal carcinoid tumor and 1 pulmonary recurrence of hepatocellular carcinoma (HCC) in 1 recipient of LRLT.


CONCLUSIONS
Basiliximab in association with tacrolimus and steroids is effective prophylaxis of ACR in liver transplant recipients and does not increase the incidence of infections or adverse effects.
Gruttadauria
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Department of Surgery, IsMeTT-UPMC, Palermo, Italy. sgruttadauria@ismett.edu
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D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000077552:Basiliximab; D003586:Cytomegalovirus Infections / Q000453:epidemiology / Q000473:pathology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006084:Graft Rejection / Q000276:immunology; D006801:Humans; D007111:Immunity, Cellular; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007275:Injections, Intravenous; D016031:Liver Transplantation / Q000276:immunology*; D008775:Methylprednisolone / Q000008:administration & dosage / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000453:epidemiology / Q000473:pathology; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D016559:Tacrolimus; D008775:Methylprednisolone