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Donor‐specific antibodies ( DSA s) are associated with an increased risk of antibody‐mediated rejection and graft failure. In  BENEFIT  and  BENEFIT ‐ EXT , kidney‐transplant recipients were randomized to receive belatacept more intense ( MI )–based, belatacept less intense ( LI )–based, or cyclosporine‐based immunosuppression for up to 7 years (84 months). The presence/absence of  HLA ‐specific antibodies was determined at baseline, at months 6, 12, 24, 36, 48, 60, and 84, and at the time of clinically suspected episodes of acute rejection, using solid‐phase flow‐cytometry screening. Samples from anti‐ HLA ‐positive patients were further tested with a single‐antigen bead assay to determine antibody specificities, presence/absence of  DSA s, and mean fluorescence intensity ( MFI ) of any  DSA s present. In  BENEFIT , de novo  DSA s developed in 1.4%, 3.5%, and 12.1% of belatacept  MI ‐treated, belatacept  LI ‐treated, and cyclosporine‐treated patients, respectively. The corresponding values in  BENEFIT ‐ EXT  were 3.8%, 1.1%, and 11.2%. Per Kaplan‐Meier analysis, de novo  DSA  incidence was significantly lower in belatacept‐treated vs cyclosporine‐treated patients over 7 years in both studies ( P  < .01). In patients who developed de novo  DSA s, belatacept‐based immunosuppression was associated with numerically lower  MFI  vs cyclosporine‐based immunosuppression. Although derived post hoc, these data suggest that belatacept‐based immunosuppression suppresses de novo  DSA  development more effectively than cyclosporine‐based immunosuppression.

american journal of transplantation

De novo donor‐specific antibodies in belatacept‐treated vs cyclosporine‐treated kidney‐transplant recipients: Post hoc analyses of the randomized phase  III BENEFIT  and  BENEFIT ‐ EXT  studies