Acute graft rejection remains a major problem among additional sequelae in
liver transplant recipients.
Basiliximab, a chimeric
monoclonal antibody with high affinity for the CD25 chain of the
interleukin-2 receptor, has significantly reduced the incidence of acute rejection episodes in renal transplant recipients. This single-arm, open-label, multicenter study investigated the efficacy and tolerability of
basiliximab immunoprophylaxis in adult patients undergoing first elective
liver transplantation. One hundred one patients (70 hepatitis C virus [HCV]-negative patients, 31 HCV-positive patients) were administered
basiliximab, 20 mg, by intravenous bolus injection the day of
transplantation (day 0) and day 4. In addition, all patients were administered triple immunosuppressive therapy with
cyclosporine,
steroids, and
azathioprine. The efficacy of
basiliximab was assessed by conventional parameters, and tolerability was assessed by the incidence of adverse events,
infections, and laboratory test result abnormalities. At 6 months, the incidence of first acute biopsy-confirmed rejection episodes was 22.8%. Rejections were more frequent in the HCV-positive (29.0%) than HCV-negative subgroup (20.0%; P =.441). No rejection episode was graded histologically as severe, and no patient required antibody
therapy for the management of acute rejection. Ten patients (9.9%) required treatment with
tacrolimus for acute rejection episodes. Patient and graft survival rates at 12 months were 90.1% and 88.1%, respectively.
Basiliximab caused no
injection-site reactions,
anaphylaxis, or
cytokine release syndrome. Five
malignancies were reported at 12 months: of these, three
malignancies predated
transplantation surgery. Compared with earlier studies, the addition of
basiliximab immunoprophylaxis to triple immunosuppressive therapy provides increased efficacy in reducing the incidence of acute rejection episodes, with no clinically significant increase in adverse events.