Belatacept maintains its renal function benefit and safety for at least five years in kidney transplant recipients, according to study results published online ahead of print in the American Journal of Transplantation.
The findings, reported by Lionel Rostaing, MD, of University Hospital in Toulouse, France, and colleagues, are from the long-term extension phase of the BENEFIT trial, a three-year, randomized, multicenter study that enrolled 666 adult patients who received a living donor or standard criteria deceased donor kidney. Results at three years demonstrated comparable patient and graft survival between belatacept and cyclosporine A (CsA).
A total of 456 patients entered the extension phase at 36 months; of these, 406 completed 60 months of treatment with either belatacept or CsA. The 406 patients included 144 treated with a more intensive (MI) regimen of belatacept; 151 treated with a less intensive (LI) regimen of belatacept, and 111 treated with CsA.
From months 36-48, one case of biopsy-confirmed acute rejection occurred in the belatacept LI group and one occurred in the CsA group. No cases occurred in the belatacept MI group. No cases of acute rejection occurred from month 48-60. Graft loss occurred in none of the belatacept recipients and in three of the CsA recipients, two from acute rejection and one from chronic allograft nephropathy. The mean calculated glomerular filtration rate (mL/min/1.73 m2) using the Modification of Diet in Renal Disease study formula at month 60 was 74 and 76 for the belatacept MI and LI groups, respectively, compared with 53 for the CsA group.
Infection and malignancy rates were generally similar among the three treatment arms.
“Based upon the evidence to date, belatacept represents an important therapeutic option for long-term immunosuppression in kidney transplant recipients,” the authors concluded.