Three-year Outcomes after Conversion from Monthly to Every 2-month Belatacept Maintenance Therapy in Kidney Transplant Recipients: Results from a Randomized Controlled Trial

• Type of Material: Article
• Authors: Aileen C. Johnson, Emory University; Geeta M. Karadkhele, Emory University; Neeta Shenvi, Emory University; Kirk Easley, Emory University; Christian Larsen, Emory University; Idelberto R. Badell, Emory University
• Language: English
• Date: 2023-02-08
• Publisher: Wolters Kluwer Health, Inc.
• Publication Version: Final Published Version
• Copyright Statement: © 2023 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1097/TXD.0000000000001449
• Title of Journal or Parent Work: Transplantation Direct
• Volume: 9
• Issue: 3
• Start Page: E1449
• End Page: E1449
• Grant/Funding Information: This study was funded by the Carlos and Marguerite Mason Trust and the James C. Kennedy and James M. Cox Foundation. The NIH/NIAID award T32AI070081 supported A.C.J.
• Research Categories: Health Sciences, Pharmacology; Health Sciences, Medicine and Surgery; Health Sciences, Immunology

Abstract

Background. Maintenance immunosuppression with belatacept following kidney transplantation results in improved long-term graft function as compared with calcineurin inhibitors. However, broad application of belatacept has been limited, in part related to logistical barriers surrounding a monthly (q1m) infusion requirement. Methods. To determine whether every 2-mo (q2m) belatacept is noninferior to standard q1m maintenance, we conducted a prospective, single-center randomized trial in low-immunologic-risk, stable renal transplant recipients. Here, post hoc analysis of 3-y outcomes, including renal function and adverse events, are reported. Results. One hundred sixty-three patients received treatment in the q1m control group (n = 82) or q2m study group (n = 81). Renal allograft function as measured by baseline-adjusted estimated glomerular filtration rate was not significantly different between groups (time-averaged mean difference of 0.2 mL/min/1.73 m2; 95% confidence interval: -2.5, 2.9). There were no statistically significant differences in time to death or graft loss, freedom from rejection, or freedom from donor-specific antibodies (DSAs). During the extended 12- to 36-mo follow-up, 3 deaths, 1 graft loss occurred in the q1m group, compared with 2 deaths, and 2 graft losses in the q2m group. In the q1m group, 1 patient developed DSAs and acute rejection. In the q2m group, 3 patients developed DSAs and 2 associated with acute rejection. Conclusions. Based on the similar renal function and survival at 36 mo compared with q1m, q2m belatacept is a potentially viable maintenance immunosuppressive strategy in low immunologic risk kidney transplant recipients that may facilitate increased clinical utilization of costimulation blockade-based immunosuppression.