Basiliximab versus steroids in double therapy immunosuppression in liver transplantation: a prospective randomized clinical trial.
BACKGROUND
: Basiliximab (B), an anti-CD25 monoclonal antibody, may represent an alternative to steroids (S) in immunosuppression after liver transplantation (LTx). The aim of this prospective randomized clinical trial was to compare B with S in a cyclosporin A (CsA)-based immunosuppression regimen in primary LTx.


METHODS
: Forty-seven adult recipients of LTx were randomly assigned to receive B or S. CsA was administered at the initial dose of 10 mg/kg/day and adjusted to the target C2 level of 800 to 1000 ng/mL by day 7. Clinically suspected acute cellular rejection (ACR) was histologically confirmed. Endpoints include ACR, survival, and disease-free survival.


RESULTS
: In group B (26 patients), there were seven biopsy-confirmed ACR with an ACR rate of 15.4%; in group S (21 patients), 8 ACR with an ACR rate of 28.6% (P=n.s.). Cumulative survival at 36 months after transplantation was 84.3% for group B and 61.0% for group S. In hepatitis C virus patients (n=20: 12 in group B, 8 in group S), the ACR rate was 25% in group B and 50% in group S. The incidence of infection and other adverse events was similar in the two treatment groups.


CONCLUSIONS
: B may represent a valid alternative to S in the induction of immunosuppression in LTx. Further studies of basiliximab in a large cohort are needed.
Department of Emergency and Organ Transplantation, Institute of General Surgery and Liver Transplantation, University of Bari, Bari, Italy.
Luigi
L
Lupo
Piercarmine
P
Panzera
Francesco
F
Tandoi
Giuseppe
G
Carbotta
Gianluigi
G
Giannelli
Teresa
T
Santantonio
Maria
M
Rendina
Antonietta
A
Gentile
Vincenzo
V
Memeo
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D019072:Antibiotic Prophylaxis; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000077552:Basiliximab; D016572:Cyclosporine / Q000627:therapeutic use; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D053645:Interleukin-2 Receptor alpha Subunit / Q000276:immunology; D016031:Liver Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D015203:Reproducibility of Results
D000305:Adrenal Cortex Hormones; D000900:Anti-Bacterial Agents; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D053645:Interleukin-2 Receptor alpha Subunit; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab