Background: The BENEFIT trial compared a more (MI) or less intensive (LI) regimen of belatacept (bela) to cyclosporine (CsA) in patients receiving a living or standard criteria deceased donor kidney transplant. Here we report the 5-year (Month 60) results of the BENEFIT LTE cohort.
Methods: Patients were randomized at transplantation to receive bela (MI or LI) or CsA. All patients received basiliximab induction/mycophenolate mofetil/corticosteroids. Patients who completed 36 mo on therapy in the original study could enroll in the LTE. Outcomes were assessed for Months 36-60 (or Year 5 database lock).
Results: 456 (68% of ITT) patients entered the LTE at 36 mo; 406 (89%) completed 60 mo. Infection and malignancy rates from Months 36-60 were similar across the bela MI, bela LI, and CsA groups, respectively: fungal infections (14%, 15%, 12%), viral infections (21%, 18%, 16%), malignancies (7%, 6%, 9%). No additional cases of PTLD occurred after 36 mo. Between Months 36-60, death occurred in 2%, 1%, and 5% of bela MI, bela LI, and CsA patients, respectively. Graft loss was observed in 0 bela and 2% of CsA patients. Mean calculated (MDRD, in mL/min/1.73 m2) GFR at Month 60 was 74 for bela MI, 76 for bela LI, and 53 for CsA. Biopsy-confirmed acute rejection episodes between Months 36-60 were rare: 0 bela MI, 1 bela LI, and 1 CsA.
Conclusions: Renal function benefits observed in belatacept-treated patients in the early posttransplant period were sustained through 5 years. There were few deaths or graft losses, and acute rejection was rare during the LTE. The belatacept safety profile was consistent with prior observations. The belatacept LI regimen provides sustained renal function benefit and a favorable safety profile through 5 years.
Vincenti, F.: Grant/Research Support, Bristol-Myers Squibb. Steinberg, S.: Other, Bristol-Myers Squibb, Travel Support. Gaite, L.: Grant/Research Support, Bristol-Myers Squibb, Speaker’s Bureau, Bristol-Myers Squibb, Other, Bristol-Myers Squibb, Board Membership from BMS Argentina. Pupim, L.: Employee, Bristol-Myers Squibb, Stockholder, Bristol-Myers Squibb. Rostaing, L.: Grant/Research Support, Wyeth, Grant to Institution, Other, Bristol-Myers Squibb, Travel Support, Veloxis, Consulting, Bristol-Myers Squibb, Advisory Board.
To cite this abstract in AMA style:Larsen C, Vincenti F, Grinyo J, Rice K, Steinberg S, Gaite L, Moal M, Pupim L, Rostaing L. Long-Term Belatacept Exposure Maintains Efficacy and Safety at 5 Years: Results from the Long-Term Extension (LTE) of the Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial (BENEFIT) Study [abstract]. Am J Transplant. 2013; 13 (suppl 5). http://atcmeetingabstracts.com/abstract/long-term-belatacept-exposure-maintains-efficacy-and-safety-at-5-years-results-from-the-long-term-extension-lte-of-the-belatacept-evaluation-of-nephroprotection-and-efficacy-as-first-line-immunosup/. Accessed November 24, 2017.
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