TY - JOUR
T1 - Outcomes at 7 years post-transplant in black vs nonblack kidney transplant recipients administered belatacept or cyclosporine in BENEFIT and BENEFIT-EXT
AU - Florman, Sander
AU - Vincenti, Flavio
AU - Durrbach, Antoine
AU - Abouljoud, Marwan
AU - Bresnahan, Barbara
AU - Garcia, Valter Duro
AU - Mulloy, Laura
AU - Rice, Kim
AU - Rostaing, Lionel
AU - Zayas Montalvo, Carlos F
AU - Calderon, Kellie
AU - Meier-Kriesche, Ulf
AU - Polinsky, Martin
AU - Yang, Lingfeng
AU - Medina Pestana, Jose
AU - Larsen, Christian P.
N1 - Funding Information:
This study was sponsored by Bristol-Myers Squibb. Medical writing and editorial assistance for this manuscript were provided by Tiffany DeSimone, PhD, of CodonMedical, an Ashfield Company, and were funded by Bristol-Myers Squibb.
Publisher Copyright:
© 2018 The Authors. Clinical Transplantation Published by John Wiley & Sons Ltd.
PY - 2018/4
Y1 - 2018/4
N2 - Clinical outcomes are generally worse for black vs nonblack renal allograft recipients. In BENEFIT and BENEFIT-EXT, recipients were randomized to belatacept more intense-based, belatacept less intense-based, or cyclosporine-based immunosuppression. At year 7, belatacept was associated with superior graft survival vs cyclosporine in BENEFIT (recipients of living or standard criteria deceased donor kidneys); belatacept was associated with similar graft survival vs cyclosporine in BENEFIT-EXT (recipients of extended criteria donor kidneys). In both studies, renal function was superior for belatacept-treated vs cyclosporine-treated patients. Seven-year outcomes were examined by race post hoc in each study. The effect of race and treatment on time to death or graft loss was compared using Cox regression. The interaction between treatment and race was also considered. Glomerular filtration rate (GFR) was estimated from months 1 to 84 using a repeated-measures model. In total, 8.3% (55/666) and 13.1% (71/543) of patients in BENEFIT and BENEFIT-EXT, respectively, were black. Time to death or graft loss was similar in blacks and nonblacks. For both subgroups, estimated mean GFR increased over 7 years for belatacept, but declined for cyclosporine. Outcomes were similar in belatacept-treated black and nonblack patients. Due to the small number of black patients, these results must be interpreted with caution.
AB - Clinical outcomes are generally worse for black vs nonblack renal allograft recipients. In BENEFIT and BENEFIT-EXT, recipients were randomized to belatacept more intense-based, belatacept less intense-based, or cyclosporine-based immunosuppression. At year 7, belatacept was associated with superior graft survival vs cyclosporine in BENEFIT (recipients of living or standard criteria deceased donor kidneys); belatacept was associated with similar graft survival vs cyclosporine in BENEFIT-EXT (recipients of extended criteria donor kidneys). In both studies, renal function was superior for belatacept-treated vs cyclosporine-treated patients. Seven-year outcomes were examined by race post hoc in each study. The effect of race and treatment on time to death or graft loss was compared using Cox regression. The interaction between treatment and race was also considered. Glomerular filtration rate (GFR) was estimated from months 1 to 84 using a repeated-measures model. In total, 8.3% (55/666) and 13.1% (71/543) of patients in BENEFIT and BENEFIT-EXT, respectively, were black. Time to death or graft loss was similar in blacks and nonblacks. For both subgroups, estimated mean GFR increased over 7 years for belatacept, but declined for cyclosporine. Outcomes were similar in belatacept-treated black and nonblack patients. Due to the small number of black patients, these results must be interpreted with caution.
KW - acute rejection
KW - cadaver organ transplantation
KW - clinical trial
KW - kidney
KW - kidney transplantation
KW - renal function
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U2 - 10.1111/ctr.13225
DO - 10.1111/ctr.13225
M3 - Article
C2 - 29461660
AN - SCOPUS:85043576012
SN - 0902-0063
VL - 32
JO - Clinical Transplantation
JF - Clinical Transplantation
IS - 4
M1 - e13225
ER -