Evaluation of Donor-Specific Antibodies Through 7 Years With Belatacept in BENEFIT and BENEFIT-EXT

R. Bray,¹ H. Gebel,¹ R. Townsend,² U. Meier-Kriesche,² C. Larsen.¹

¹Emory University, Atlanta
²Bristol-Myers Squibb, Lawrenceville.

Meeting: 2015 American Transplant Congress

Abstract number: 305

Keywords: Antibodies, Immunosuppression, Kidney transplantation

Session Information

Session Name: Concurrent Session: Kidney: Novel Agents

Session Type: Concurrent Session

Date: Monday, May 4, 2015

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 (FLowPRA^TM), and specificity (Class I and II) was assessed by LabScreen^TM 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 November 21, 2024.

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