title: Early corticosteroid withdrawal in the real world: a long-term analysis of kidney transplant recipients from the Mycophenolic Acid Observational Renal Transplant Registry.
abstract: BACKGROUND
  Prospective, long-term data on corticosteroid withdrawal (CSW) versus corticosteroid continuation (CSC) following kidney transplantation are scarce.
  
  
  METHODS
  The Mycophenolic Renal Transplant (MORE) Registry was a prospective, observational study of de novo kidney transplant patients receiving mycophenolic acid (MPA) and standard of care. Adult patients receiving tacrolimus and enteric-coated mycophenolate sodium (EC-MPS) or mycophenolate mofetil (MMF) at time of transplant were analyzed to 4 years according to CSW by month 3 (n=363) or CSC (n=509).
  
  
  RESULTS
  In the CSW and CSC groups, 3.3% and 13.0% had undergone retransplantation (p<0.001), 89.9% and 77.0% had panel reactive antibodies <30% (p<0.001), and 72.5% and 87.2% received pretransplant dialysis (p<0.001), respectively. Rabbit antithymocyte induction was used in 62.3% of CSW patients and 58.6% of CSC patients (p=0.015), and alemtuzumab in 23.7% and 4.7%, respectively (p=0.002). At all time points to 3 years post-transplant, significantly fewer CSW patients were maintained on the full recommended dose of MPA versus CSC patients. Biopsy-proven acute rejection occurred in 10.1% and 14.3% of CSW and CSC patients (p=0.12), graft survival was 96.9% versus 93.7% (p=0.030), and patient survival was 95.6% versus 95.0% (p=0.65), respectively. Adverse events were similar except for leukopenia (CSW 60.6%, CSC 29.9%; p<0.001) and neutropenia (CSW 17.4%, CSC 11.4%; p=0.013), with infections in 24.8% and 30.8% of CSW and CSC patients, respectively (p=0.057).
  
  
  CONCLUSIONS
  CSW patients were less likely to receive the full dose of MPA than CSC patients, possibly due to induction-related hematological toxicity. Graft survival to 4 years post-transplant was superior in CSW patients.
authors.affiliation: Department of Transplantation, California Pacific Medical Center, San Francisco, USA.
authors.forename: Kimi
authors.initials: K
authors.lastname: Ueda
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, USA.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: McCague
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Wiland
authors.affiliation: Department of Transplantation, California Pacific Medical Center, San Francisco, USA.
authors.forename: V Ram
authors.initials: VR
authors.lastname: Peddi
mesh_terms: D000006:Abdomen, Acute; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy* / Q000453:epidemiology; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007239:Infections / Q000453:epidemiology; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis* / Q000453:epidemiology; D016559:Tacrolimus / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D016559:Tacrolimus