title: Lower risk of infectious deaths in cardiac transplant patients receiving basiliximab versus anti-thymocyte globulin as induction therapy.
abstract: BACKGROUND
  Conventional antibody induction therapy is currently used in heart transplantation despite safety concerns. This 6-month, prospective, randomized, multicenter, open-label study examined whether basiliximab offers a tolerability benefit compared with anti-thymocyte globulin (ATG) while maintaining similar efficacy in de novo heart transplant recipients.
  
  
  METHODS
  Adult heart transplant recipients were randomized to receive basiliximab (20 mg on Day 0 and Day 4) or ATG (2.5 mg/kg/day for 3 to 5 days) with cyclosporine, mycophenolate mofetil and steroids. The primary safety end-point was a composite of serum sickness, fever, cutaneous rash, anaphylaxis, infection, thrombocytopenia, leukopenia and post-transplant proliferative disease. Efficacy was assessed by a composite end-point of death, graft loss, acute rejection Grade > 1B, acute rejection associated with hemodynamic compromise or treated with antibody therapy, or loss to follow-up, whichever occurred first.
  
  
  RESULTS
  Eighty patients were randomized and analyzed. By Month 6, the incidence of the composite safety end-point was significantly lower with basiliximab than with ATG (50.0% vs 78.6%, p = 0.01), and infectious death was less frequent in the basiliximab group (0 of 38 vs 6 of 42, p = 0.027). The composite efficacy end-point occurred in 24 patients (63.2%) in the basiliximab arm vs 28 patients (66.7%, p = not significant [NS]) receiving ATG. Acute rejection episodes of Grade > or = 1B were reported with similar frequency (50% with basiliximab vs 45.2% with ATG, p = NS); 7 patients (18.4%) in the basiliximab group and 3 (7.1%) in the ATG group had rejection Grade > or = 3A.
  
  
  CONCLUSIONS
  These results suggest that basiliximab offers improved tolerability with similar efficacy compared with current polyclonal antibody induction therapy in de novo heart transplant patients.
authors.affiliation: Department of Cardiology and Transplantation, Hôpital Brabois, Nancy, France. mf.mattei@chu-nancy.fr
authors.forename: Marie Françoise
authors.initials: MF
authors.lastname: Mattei
authors.forename: Michel
authors.initials: M
authors.lastname: Redonnet
authors.forename: Iradj
authors.initials: I
authors.lastname: Gandjbakhch
authors.forename: Annick Mouly
authors.initials: AM
authors.lastname: Bandini
authors.forename: Allain
authors.initials: A
authors.lastname: Billes
authors.forename: Eric
authors.initials: E
authors.lastname: Epailly
authors.forename: Romain
authors.initials: R
authors.lastname: Guillemain
authors.forename: Bernard
authors.initials: B
authors.lastname: Lelong
authors.forename: Annie
authors.initials: A
authors.lastname: Pol
authors.forename: Michelle
authors.initials: M
authors.lastname: Treilhaud
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Vermes
authors.forename: Richard
authors.initials: R
authors.lastname: Dorent
authors.forename: Djamila
authors.initials: D
authors.lastname: Lemay
authors.forename: Anne Sandrine
authors.initials: AS
authors.lastname: Blanc
authors.forename: Pascale
authors.initials: P
authors.lastname: Boissonnat
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000961:Antilymphocyte Serum / Q000009:adverse effects / Q000627:therapeutic use*; D000077552:Basiliximab; D003141:Communicable Diseases / Q000209:etiology* / Q000401:mortality; D016572:Cyclosporine / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D005260:Female; D006084:Graft Rejection / Q000276:immunology; D016027:Heart Transplantation / Q000009:adverse effects* / Q000276:immunology / Q000379:methods*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D013256:Steroids / Q000627:therapeutic use; D014181:Transplantation Immunology; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D013256:Steroids; D016572:Cyclosporine; D000077552:Basiliximab; D009173:Mycophenolic Acid