title: Immunoprophylaxis with basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, in combination with azathioprine-containing triple therapy in liver transplant recipients.
abstract: 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.
authors.affiliation: Hôpital Cochin, Service de Transplantation Hépatique, Paris, France. yvon.calmus@cch.ap-hop-paris.fr
authors.forename: Yvon
authors.initials: Y
authors.lastname: Calmus
authors.forename: Johannes R
authors.initials: JR
authors.lastname: Scheele
authors.forename: Ignacio
authors.initials: I
authors.lastname: Gonzalez-Pinto
authors.forename: Eduardo J
authors.initials: EJ
authors.lastname: Jaurrieta
authors.forename: Ernst
authors.initials: E
authors.lastname: Klar
authors.forename: Georges P
authors.initials: GP
authors.lastname: Pageaux
authors.forename: Charles H
authors.initials: CH
authors.lastname: Scudamore
authors.forename: Valentin
authors.initials: V
authors.lastname: Cuervas-Mons
authors.forename: Herold J
authors.initials: HJ
authors.lastname: Metselaar
authors.forename: Hans
authors.initials: H
authors.lastname: Prestele
authors.forename: Daniele
authors.initials: D
authors.lastname: Girault
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use*; D000077552:Basiliximab; D002102:Cadaver; D004359:Drug Therapy, Combination; D006084:Graft Rejection / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016031:Liver Transplantation / Q000276:immunology*; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D015375:Receptors, Interleukin-2 / Q000276:immunology*; D011993:Recombinant Fusion Proteins; D015996:Survival Rate; D014019:Tissue Donors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D015375:Receptors, Interleukin-2; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D001379:Azathioprine; D008775:Methylprednisolone