Long‐Term Belatacept Exposure Maintains Efficacy and Safety at 5 Years: Results From the Long‐Term Extension of the BENEFIT Study. Issue 11 (18th September 2013)

• Record Type: Journal Article
• Authors: Rostaing, L.; Vincenti, F.; Grinyó, J.; Rice, K. M.; Bresnahan, B.; Steinberg, S.; Gang, S.; Gaite, L. E.; Moal, M.‐C.; Mondragón‐Ramirez, G. A.; Kothari, J.; Pupim, L.; Larsen, C. P.
• Is Part Of: American journal of transplantation. Volume 13:Issue 11(2013)
• Page Start: 2875
• Page End: 2883
• Publication Date: 2013-09-18
• Subjects: Belatacept -- cyclosporine A -- kidney -- renal function; Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ajt.12460
• Languages: English
• ISSNs: 1600-6135

Abstract

Abstract: 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. Abstract : This report presents the 5‐year efficacy and safety results for the BENEFIT study of belatacept versus cyclosporine in kidney transplant. Also see article by Charpentier et al on page 2884.