title: Acute rejection characteristics from a prospective, randomized, double-blind, placebo-controlled multicenter trial of early corticosteroid withdrawal.
abstract: BACKGROUND
  This report characterizes acute rejection and rejection outcomes in subjects randomized to continuous corticosteroid therapy (CCS) or early corticosteroid withdrawal (CSWD; 7 days after transplantation) in the Astellas Blinded CSWD Trial.
  
  
  METHODS
  The Astellas Blinded CSWD Trial was a 5-year, prospective, multicenter, randomized, double-blind trial of early CCS withdrawal in 386 kidney transplant recipients (195 CCS and 191 CSWD). Tacrolimus and mycophenolate mofetil were required as well as either rabbit antithymocyte globulin or interleukin-2 receptor antibody induction. Biopsy-confirmed acute rejection (BCAR) was grade 1A or higher by Banff criteria. This report also provides borderline changes (BL) that did not meet Banff grade 1A included with BCAR (BCAR+BL).
  
  
  RESULTS
  BCAR+BL was 25 (12.8%) in CCS group and 42 (22.0%) in CSWD group (P=0.022). Early BCAR+BL (first 90 days after transplantation) was less frequent in CCS (n=5 [2.6%]) than in CSWD (n=22 [11.5%]; P<0.001). Among non-African-American subjects, early BCAR+BL occurred more often in CSWD (n=20 [12.7%]) versus CCS (n=2 [1.3%]; P<0.001). Late acute rejection (>2 years) occurred more often in African-American subjects in CCS (n=5 [13.9%]) than in CSWD (n=0; P=0.056). Risk factors were CSWD (hazard ratio [HR], 4.72; P<0.002) and human leukocyte antigen mismatch (HR, 1.48; P<0.005) for early BCAR+BL and CSWD (HR, 1.9; P<0.02), human leukocyte antigen mismatch (HR, 1.2; P<0.01), and age (HR, 0.97; P<0.002) for 5-year rejection. The HR for graft loss associated with BCAR+BL was 8.8.
  
  
  CONCLUSIONS
  BCAR+BL may occur more frequently during the early period after transplantation under an early CSWD regimen with tacrolimus plus induction compared with CCS, particularly among non-African-Americans.
authors: Department of Surgery, The Methodist Hospital, 6550 Fannin Street, SM1661, Houston, TX 77030, USA. aogaber@tmhs.org
authors: A Osama
authors: AO
authors: Gaber
authors: Linda W
authors: LW
authors: Moore
authors: Rita R
authors: RR
authors: Alloway
authors: E Steve
authors: ES
authors: Woodle
authors: John
authors: J
authors: Pirsch
authors: Fuad
authors: F
authors: Shihab
authors: Alice
authors: A
authors: Henning
authors: William
authors: W
authors: Fitzsimmons
authors: John
authors: J
authors: Holman
authors: Robin
authors: R
authors: Reisfield
authors: M Roy
authors: MR
authors: First
mesh_terms: D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects; D001741:Black or African American; D000367:Age Factors; D000961:Antilymphocyte Serum / Q000008:administration & dosage; D001706:Biopsy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006084:Graft Rejection / Q000208:ethnology / Q000276:immunology / Q000473:pathology / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D006680:HLA Antigens / Q000276:immunology; D006648:Histocompatibility; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016030:Kidney Transplantation / Q000208:ethnology / Q000276:immunology*; D015999:Multivariate Analysis; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D016017:Odds Ratio; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012307:Risk Factors; D016559:Tacrolimus / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000305:Adrenal Cortex Hormones; D000961:Antilymphocyte Serum; D006680:HLA Antigens; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D016559:Tacrolimus