title: Belatacept-based regimens versus a cyclosporine A-based regimen in kidney transplant recipients: 2-year results from the BENEFIT and BENEFIT-EXT studies.
abstract: BACKGROUND
  At 1 year, belatacept was associated with similar patient/graft survival, better renal function, and an improved cardiovascular/metabolic risk profile versus cyclosporine A (CsA) in the Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial (BENEFIT) and Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial-EXTended criteria donors (BENEFIT-EXT) studies. Acute rejection was more frequent with belatacept in BENEFIT. Posttransplant lymphoproliferative disorder (PTLD)--specifically central nervous system PTLD--was observed more frequently in belatacept-treated patients. This analysis assesses outcomes from BENEFIT and BENEFIT-EXT after 2 years of treatment.
  
  
  METHODS
  Patients received a more intensive (MI) or a less intensive (LI) regimen of belatacept or a CsA-based regimen.
  
  
  RESULTS
  Four hundred ninety-three of 666 patients (74%) in BENEFIT and 347 of 543 (64%) in BENEFIT-EXT completed 2 years of treatment. The proportion of patients who survived with a functioning graft was similar across groups (BENEFIT: 94% MI, 95% LI, and 91% CsA; BENEFIT-EXT: 83% MI, 84% LI, and 83% CsA). Belatacept's renal benefits were sustained, as evidenced by a 16 to 17 mL/min (BENEFIT) and an 8 to 10 mL/min (BENEFIT-EXT) higher calculated glomerular filtration rate in the belatacept groups versus CsA. There were few new acute rejection episodes in either study between years 1 and 2. Because PTLD risk was highest in Epstein-Barr virus (EBV) (-) patients, an efficacy analysis of EBV (+) patients was performed and was consistent with the overall population results. There were two previously reported cases of PTLD in each study between years 1 and 2 in the belatacept groups. The overall balance of safety and efficacy favored the LI over the MI regimen.
  
  
  CONCLUSIONS
  At 2 years, belatacept-based regimens sustained better renal function, similar patient/graft survival, and an improved cardiovascular/metabolic risk profile versus CsA; outcomes that were maintained in EBV (+) patients. No new safety signals emerged.
authors.affiliation: Emory Transplant Center and Department of Surgery, Emory University, Atlanta, GA, USA. clarsen@emory.edu
authors.forename: Christian P
authors.initials: CP
authors.lastname: Larsen
authors.forename: Josep
authors.initials: J
authors.lastname: Grinyó
authors.forename: José
authors.initials: J
authors.lastname: Medina-Pestana
authors.forename: Yves
authors.initials: Y
authors.lastname: Vanrenterghem
authors.forename: Flavio
authors.initials: F
authors.lastname: Vincenti
authors.forename: Barbara
authors.initials: B
authors.lastname: Breshahan
authors.forename: Josep M
authors.initials: JM
authors.lastname: Campistol
authors.forename: Sander
authors.initials: S
authors.lastname: Florman
authors.forename: Maria del Carmen
authors.initials: Mdel C
authors.lastname: Rial
authors.forename: Nassim
authors.initials: N
authors.lastname: Kamar
authors.forename: Alan
authors.initials: A
authors.lastname: Block
authors.forename: Gregory
authors.initials: G
authors.lastname: Di Russo
authors.forename: Chen-Sheng
authors.initials: CS
authors.lastname: Lin
authors.forename: Pushkal
authors.initials: P
authors.lastname: Garg
authors.forename: Bernard
authors.initials: B
authors.lastname: Charpentier
mesh_terms: D000069594:Abatacept; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006085:Graft Survival / Q000187:drug effects / Q000502:physiology; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D008232:Lymphoproliferative Disorders / Q000453:epidemiology; D011183:Postoperative Complications / Q000453:epidemiology; D018570:Risk Assessment; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D016572:Cyclosporine