Long-Term Belatacept Exposure Maintains Efficacy and Safety at 5 Years: Results From the Long-Term Extension of the BENEFIT Study.

AJT Long-Term Belatacept Exposure Maintains Efficacy and Safety at 5 Years: Results From the Long-Term Extension of the BENEFIT Study.

• Rostaing L, Vincenti F, Grinyó J, et al. 
• Long-Term Belatacept Exposure Maintains Efficacy and Safety at 5 Years: Results From the Long-Term Extension of the BENEFIT Study. [JOURNAL ARTICLE]
• Am J Transplant 2013 Sep 18.

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.

http://www.unboundmedicine.com/medline/citation/24047110/Long_Term_Belatacept_Exposure_Maintains_Efficacy_and_Safety_at_5_Years:_Results_From_the_Long_Term_Extension_of_the_BENEFIT_Study_