Session Time: 4:00pm-5:30pm
Presentation Time: 4:12pm-4:24pm
Location: Terrace I-III
Purpose: The development of donor-specific antibody (DSA) is linked to an increased risk of antibody-mediated rejection and graft failure. The 3 year intent-to-treat results from BENEFIT and BENEFIT-EXT showed lower rates of de novo (DN) DSA with belatacept (3% for both more intensive [MI] and less intensive [LI] belatacept) than with cyclosporine (CsA; 8%). From baseline through Year 5, there was also a reduced rate of DN DSA with belatacept compared with CsA in patients enrolled in the BENEFIT and BENEFIT-EXT long-term extension (LTE) studies. Here we report the DN DSA rates from baseline through Year 7 in BENEFIT and BENEFIT-EXT.
Methods: In BENEFIT, patients received living donor or standard criteria donor kidneys, and in BENEFIT-EXT, patients received extended criteria donor kidneys. Patients received MI or LI belatacept or CsA and could enter the LTE after 3 years. DN DSA rates were assessed for all randomized and treated patients from baseline through Year 7. The presence of DSA was established centrally by solid phase flow cytometry (FLowPRATM), and specificity (Class I and II) was assessed by LabScreenTM single antigen beads (One Lambda, Inc.).
Results: BENEFIT included 666 patients in the belatacept MI (n=219), belatacept LI (n=226) and CsA (n=221) groups. In BENEFIT, DN DSA occurred in 3 MI, 7 LI, and 25 CsA-treated patients. DN DSA specificity were against Class I HLA in 1 (MI), 3 (LI) and 7 (CsA)-treated patients, Class II HLA in 2 (MI), 4 (LI) and 14 (CsA)-treated patients, and both Class I and II HLA in 4 patients receiving CsA.
BENEFIT-EXT included 543 patients in the belatacept MI (n=184), belatacept LI (n=175), and CsA (n=184) groups. In BENEFIT-EXT, DN DSA occurred in 7 MI, 3 LI, and 22 CsA-treated patients. DN DSA specificity were against Class I HLA in 5 (MI), 3 (LI) and 15 (CsA)-treated patients, Class II HLA in 2 (MI) and 3 (CsA)-treated patients, and both Class I and II HLA in 4 patients in the CsA arm.
Conclusions: Data from BENEFIT and BENEFIT-EXT through Year 7 continue to demonstrate a reduced incidence of DN DSA with belatacept (MI or LI) vs. CsA, consistent with earlier findings (at Year 3 and Year 5).
To cite this abstract in AMA style:Bray R, Gebel H, Townsend R, Meier-Kriesche U, Larsen C. Evaluation of Donor-Specific Antibodies Through 7 Years With Belatacept in BENEFIT and BENEFIT-EXT [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/evaluation-of-donor-specific-antibodies-through-7-years-with-belatacept-in-benefit-and-benefit-ext/. Accessed July 19, 2018.
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