Document Detail


Belatacept-based regimens versus a cyclosporine A-based regimen in kidney transplant recipients: 2-year results from the BENEFIT and BENEFIT-EXT studies.
MedLine Citation:
PMID:  21076381     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Christian P Larsen; Josep Grinyó; José Medina-Pestana; Yves Vanrenterghem; Flavio Vincenti; Barbara Breshahan; Josep M Campistol; Sander Florman; Maria del Carmen Rial; Nassim Kamar; Alan Block; Gregory Di Russo; Chen-Sheng Lin; Pushkal Garg; Bernard Charpentier
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Transplantation     Volume:  90     ISSN:  1534-6080     ISO Abbreviation:  Transplantation     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-12-16     Completed Date:  2011-01-28     Revised Date:  2013-05-24    
Medline Journal Info:
Nlm Unique ID:  0132144     Medline TA:  Transplantation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1528-35     Citation Subset:  IM    
Affiliation:
Emory Transplant Center and Department of Surgery, Emory University, Atlanta, GA, USA. clarsen@emory.edu
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MeSH Terms
Descriptor/Qualifier:
Cyclosporine / adverse effects,  therapeutic use*
Follow-Up Studies
Graft Survival / drug effects,  physiology
Humans
Immunoconjugates / adverse effects,  therapeutic use*
Immunosuppressive Agents / adverse effects,  therapeutic use*
Kidney Function Tests
Kidney Transplantation / immunology*,  mortality
Lymphoproliferative Disorders / epidemiology
Postoperative Complications / epidemiology
Risk Assessment
Survival Rate
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Immunoconjugates; 0/Immunosuppressive Agents; 59865-13-3/Cyclosporine; 7D0YB67S97/abatacept

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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