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Lower risk of infectious deaths in cardiac transplant patients receiving basiliximab versus anti-thymocyte globulin as induction therapy.

AbstractBACKGROUND:
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.
AuthorsMarie Françoise Mattei, Michel Redonnet, Iradj Gandjbakhch, Annick Mouly Bandini, Allain Billes, Eric Epailly, Romain Guillemain, Bernard Lelong, Annie Pol, Michelle Treilhaud, Emmanuelle Vermes, Richard Dorent, Djamila Lemay, Anne Sandrine Blanc, Pascale Boissonnat
JournalThe Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation (J Heart Lung Transplant) Vol. 26 Issue 7 Pg. 693-9 (Jul 2007) ISSN: 1557-3117 [Electronic] United States
PMID17613399 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Monoclonal
  • Antilymphocyte Serum
  • Immunosuppressive Agents
  • Recombinant Fusion Proteins
  • Steroids
  • Cyclosporine
  • Basiliximab
  • Mycophenolic Acid
Topics
  • Adolescent
  • Adult
  • Aged
  • Antibodies, Monoclonal (adverse effects, therapeutic use)
  • Antilymphocyte Serum (adverse effects, therapeutic use)
  • Basiliximab
  • Communicable Diseases (etiology, mortality)
  • Cyclosporine (therapeutic use)
  • Drug Therapy, Combination
  • Endpoint Determination
  • Female
  • Graft Rejection (immunology)
  • Heart Transplantation (adverse effects, immunology, methods)
  • Humans
  • Immunosuppressive Agents (adverse effects, therapeutic use)
  • Male
  • Middle Aged
  • Mycophenolic Acid (analogs & derivatives, therapeutic use)
  • Prospective Studies
  • Recombinant Fusion Proteins (adverse effects, therapeutic use)
  • Risk Factors
  • Steroids (therapeutic use)
  • Transplantation Immunology
  • Treatment Outcome

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