Belatacept-versus cyclosporine-based immunosuppression in renal transplant
recipients with pre-existing diabetes.
Author(s): Rostaing L, Neumayer HH, Reyes-Acevedo R, Bresnahan B, Florman S, Vitko S,
Heifets M, Xing J, Thomas D, Vincenti F.
Affiliation(s): Department of Nephrology, Dialysis and Multiorgan Transplantation, University
Hospital, Toulouse, France. rostaing.l@chu-toulouse.fr
Publication date & source: 2011, Clin J Am Soc Nephrol. , 6(11):2696-704
BACKGROUND AND OBJECTIVES: Renal transplant recipients with pre-existing diabetes
(PD) have reduced graft survival and increased risk of mortality and ischemic
heart disease compared with nondiabetic transplant recipients. To assess the
effect of belatacept in this high-risk group, we evaluated outcomes of the
subpopulation with PD from previously published BENEFIT and BENEFIT-EXT trials.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A post hoc analysis evaluated
pooled data from BENEFIT (living donors or standard criteria donors) and
BENEFIT-EXT (extended criteria donors). Patients were randomized to receive
cyclosporine or a more intensive (MI) or less intensive (LI) belatacept regimen.
RESULTS: Of 1209 intent-to-treat patients, 336 had PD. At 12 months, the
belatacept LI arm demonstrated a numerically higher rate of patients surviving
with a functioning graft (90.4% MI [103 of 114], 92.8% LI [90 of 97], and 80.8%
cyclosporine [101 of 125]), and fewer serious adverse events than cyclosporine or
MI patients. Three cases of posttransplant lymphoproliferative disorder were
reported in LI patients, one involving the central nervous system. Higher rates
(% [95% confidence interval]: 22.8% MI [15.1 to 30.5]; 20.6% LI [12.6 to 28.7];
14.4% cyclosporine (8.2 to 20.6]) and grades of acute rejection were observed
with belatacept. Measured GFR (ml/min per 1.73 m(2), 59.8 MI; 62.5 LI; 45.4
cyclosporine), and cardiovascular risk profile were better for belatacept versus
cyclosporine.
CONCLUSIONS: In post hoc analysis of patients with PD, patient/graft survival and
renal function at 12 months were numerically higher with belatacept versus
cyclosporine, but not statistically significant. Further study is necessary to
confirm the benefits belatacept may provide in these patients.
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