Document Detail


Long-Term Belatacept Exposure Maintains Efficacy and Safety at 5 Years: Results From the Long-Term Extension of the BENEFIT Study.
MedLine Citation:
PMID:  24047110     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial randomized patients receiving a living or standard criteria deceased donor kidney transplant to a more (MI) or less intensive (LI) regimen of belatacept or cyclosporine A (CsA). The 5-year results of the long-term extension (LTE) cohort are reported. A total of 456 (68.5% of intent-to-treat) patients entered the LTE at 36 months; 406 patients (89%) completed 60 months. Between Months 36 and 60, death occurred in 2%, 1% and 5% of belatacept MI, belatacept LI and CsA patients, respectively; graft loss occurred in 0% belatacept and 2% of CsA patients. Acute rejection between Months 36 and 60 was rare: zero belatacept MI, one belatacept LI and one CsA. Rates for infections and malignancies for Months 36-60 were generally similar across belatacept groups and CsA, respectively: fungal infections (14%, 15%, 12%), viral infections (21%, 18%, 16%) and malignancies (6%, 6%, 9%). No new posttransplant lymphoproliferative disorder cases occurred after 36 months. Mean calculated GFR (MDRD, mL/min/1.73 m(2) ) at Month 60 was 74 for belatacept MI, 76 for belatacept LI and 53 for CsA. These results show that the renal function benefit and safety profile observed in belatacept-treated patients in the early posttransplant period was sustained through 5 years.
Authors:
L Rostaing; F Vincenti; J Grinyó; K M Rice; B Bresnahan; S Steinberg; S Gang; L E Gaite; M-C Moal; G A Mondragón-Ramirez; J Kothari; L Pupim; C P Larsen
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-9-18
Journal Detail:
Title:  American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons     Volume:  -     ISSN:  1600-6143     ISO Abbreviation:  Am. J. Transplant.     Publication Date:  2013 Sep 
Date Detail:
Created Date:  2013-9-19     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100968638     Medline TA:  Am J Transplant     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.
Affiliation:
University Hospital, Toulouse, France; INSERM U563, IFR-BMT, Toulouse, France.
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