title: Completely steroid-free immunosuppression in liver transplantation: a randomized study.
abstract: BACKGROUND
  Corticosteroids (CS) have been standard immunosuppression to prevent and treat rejection. However, CS are associated with increased risk of infection, obesity, hypertension, hyperlipidemia, diabetes, and accelerated hepatitis C virus (HCV) recurrence post-orthotopic liver transplantation (OLT). This study assesses the safety and efficacy of CS-free immunosuppressive regimen in adult OLT.
  
  
  METHODS
  A two-yr, prospective, randomized study of CS with delayed withdrawal (CS) or CS-free regimen with basiliximab, tacrolimus, and enteric-coated mycophenolate sodium (EC-MPS) was performed in 39 patients (CS=20; CS-free=19). CS group received intra-operative methylprednisolone weaned by six months. HCV patients had HCV PCR pre-OLT and 0.5, one, three, and six months post-OLT. Protocol liver biopsies were performed at OLT, 2 and 24 wk post-OLT or when indicated.
  
  
  RESULTS
  Rejection occurred in two patients. Patient survival at one yr (100% vs. 95%), three yr (85% vs. 63%), and five yr (80% vs. 63%) post-OLT were similar between CS and CS-free group, respectively. Death-censored graft survival at one yr (100% vs. 95%), three yr (85% vs. 63%), and five yr (75% vs. 63%) were also similar. The risk of new-onset DM, hypertension, hypercholesterolemia, and weight gain was similar between groups.
  
  
  CONCLUSIONS
  CS avoidance with basiliximab, calcineurin inhibitor, and EC-MPS is safe and effective as CS- containing immunosuppression in adult OLT.
authors.affiliation: Division of Transplantation, Department of Surgery, Thomas Jefferson University, Philadelphia, PA19107, USA. carlo.ramirez@jefferson.edu
authors.forename: Carlo B
authors.initials: CB
authors.lastname: Ramirez
authors.forename: Cataldo
authors.initials: C
authors.lastname: Doria
authors.forename: Adam M
authors.initials: AM
authors.lastname: Frank
authors.forename: Stephen T
authors.initials: ST
authors.lastname: Armenti
authors.forename: Ignazio R
authors.initials: IR
authors.lastname: Marino
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D007165:Immunosuppression Therapy / Q000401:mortality*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008107:Liver Diseases / Q000401:mortality / Q000601:surgery*; D016031:Liver Transplantation; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D010865:Pilot Projects; D011379:Prognosis; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D016559:Tacrolimus; D008775:Methylprednisolone