• Am. J. Transplant. · Nov 2013

    Randomized Controlled Trial Multicenter Study

    Long-term belatacept exposure maintains efficacy and safety at 5 years: results from the long-term extension of the BENEFIT study.

    • 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, and C P Larsen.
    • University Hospital, Toulouse, France; INSERM U563, IFR-BMT, Toulouse, France.
    • Am. J. Transplant. 2013 Nov 1; 13 (11): 2875-83.

    AbstractThe 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.© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.

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