Long-Term Exposure to Belatacept in Recipients of Extended Criteria Donor Kidneys

Patients in the BENEFIT-EXT study received extended criteria donor kidneys and a more intensive (MI) or less intensive (LI) belatacept immunosuppression regimen, or cyclosporine A (CsA). Patients who remained on assigned therapy through year 3 were eligible to enter a long-term extension (LTE) study. Three hundred four patients entered the LTE (n=104 MI; n=113 LI; n=87 CsA), and 260 continued treatment through year 5 (n=91 MI; n=100 LI; n=69 CsA). Twenty patients died during the LTE (n=5 MI; n=9 LI; n=6 CsA), and eight experienced graft loss (n=2 MI; n=1 LI; n=5 CsA). Three patients experienced an acute rejection episode (n=2 MI; n=1 LI). The incidence rate of serious adverse events, viral infections and fungal infections was similar across groups during the LTE. There were four cases of posttransplant lymphoproliferative disorder (PTLD) from the beginning of the LTE to year 5 (n=3 LI; n=1 CsA); two of three PTLD cases in the LI group were in patients who were seronegative for Epstein-Barr virus (EBV(-)) at transplantation. MeanSD calculated GFR at year 5 was 55.9 +/- 17.5 (MI), 59.0 +/- 29.1 (LI) and 44.6 +/- 16.4 (CsA)mL/min/1.73m(2). Continued treatment with belatacept was associated with a consistent safety profile and sustained improvement in renal function versus CsA over time. Recipients of extended criteria donor kidneys in the BENEFIT-EXT study who continued treatment with belatacept in a long-term study extension exhibited a consistent safety profile and maintained an 1114 mL/min/1.73 m(2) higher GFR versus cyclosporine at 5 years posttransplant. Also see article by Rostaing et al on page 2875.