title: Daclizumab is associated with decreased rejection and no increased mortality in cardiac transplant patients receiving MMF, cyclosporine, and corticosteroids.
abstract: BACKGROUND
  Sparse published data exist on outcomes in daclizumab-treated cardiac transplant patients. One trial observed an increased mortality risk 6 and 12 months posttransplant in patients receiving daclizumab plus mycophenolate mofetil (MMF), cyclosporine, and steroids. This study further investigates the safety profile of daclizumab with this same immunosuppressive regimen from a large registry.
  
  
  METHODS
  Data obtained at hospital discharge on all adult cardiac transplants performed in the USA between January 1998 and October 2003 for patients receiving MMF plus cyclosporine and steroids were accessed from the Scientific Registry of Transplant Recipients. Patients were selected based on induction treatment: daclizumab (n = 684) or no induction (n = 2525). Outcomes were evaluated at 6 months, 12 months, and 3 years posttransplant. Univariate Kaplan-Meier and multivariate Cox models were used to evaluate the effect of treatment on outcomes. Patient survival and infectious death were the primary endpoints. Secondary endpoints included rejection within the first year posttransplant (acute rejection; AR) and total rejection episodes over time. The two treatment groups shared similar demographics and transplant procedure details.
  
  
  RESULTS
  Daclizumab (vs no induction) patients had no increased risk of patient death nor infectious death. Daclizumab patients had a lower incidence of AR at 6 months (P = .005) and 12 months (P < .001); the adjusted risk for AR at 12 months (hazards ratio [HR] = 0.77; P = .89) and over 3 years (HR 0.83, P = .006) was also lower in daclizumab-treated patients.
  
  
  CONCLUSIONS
  In cardiac transplant patients, daclizumab (vs no induction) does not result in increased mortality or infectious death, and is associated with a lower incidence of AR.
authors.affiliation: University of California, Los Angeles, Los Angeles, California 90095, USA. jonk@mednet.ucla.edu
authors.forename: J
authors.initials: J
authors.lastname: Kobashigawa
authors.forename: K
authors.initials: K
authors.lastname: David
authors.forename: J
authors.initials: J
authors.lastname: Morris
authors.forename: A H
authors.initials: AH
authors.lastname: Chu
authors.forename: B J
authors.initials: BJ
authors.lastname: Steffen
authors.forename: V P
authors.initials: VP
authors.lastname: Gotz
authors.forename: R D
authors.initials: RD
authors.lastname: Gordon
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000077561:Daclizumab; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control*; D016027:Heart Transplantation / Q000276:immunology* / Q000401:mortality; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015994:Incidence; D007239:Infections / Q000453:epidemiology / Q000401:mortality; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011183:Postoperative Complications / Q000145:classification / Q000453:epidemiology / Q000401:mortality; D012042:Registries; D016019:Survival Analysis; D013997:Time Factors; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000077561:Daclizumab