title: Comparison of Utilization and Clinical Outcomes for Belatacept- and Tacrolimus-Based Immunosuppression in Renal Transplant Recipients.
abstract: The performance of belatacept in a real clinical setting has not been reported. A retrospective cohort study was conducted using registry data comparing 1-year clinical outcomes between belatacept- and tacrolimus-treated adult kidney transplant recipients (KTRs) from January 6, 2011, through January 12, 2014. Of 50 244 total patients, 417 received belatacept plus tacrolimus, 458 received belatacept alone, and 49 369 received tacrolimus alone at discharge. In the overall study cohort, belatacept alone was associated with a higher risk of 1-year acute rejection, with the highest rates associated with non-lymphocyte-depleting induction (adjusted hazard ratio 2.65, 95% confidence interval 1.90-3.70, p < 0.0001). There was no significant difference in rejection rates between belatacept plus tacrolimus and tacrolimus alone. In KTRs who met inclusion criteria for the Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial-Extended Criteria Donors (BENEFIT-EXT), 1-year kidney function was higher with belatacept plus tacrolimus and belatacept alone versus tacrolimus alone (mean estimated GFR 65.6, 60.4 and 54.3 mL/min per 1.73 m2, respectively; p < 0.001). The incidence of new-onset diabetes after transplantation was significantly lower with belatacept plus tacrolimus and belatacept alone versus tacrolimus alone (1.7%, 2.2%, and 3.8%, respectively; p = 0.01). Despite improved graft function and metabolic complications with belatacept alone, it may be advisable to add short-term tacrolimus in the first year after transplant and to consider lymphocyte-depleting induction in patients with high rejection risk, as the risk-benefit ratio allows.
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL. xuerong.wen@medicine.ufl.edu.
authors.forename: X
authors.initials: X
authors.lastname: Wen
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL.
authors.forename: M J
authors.initials: MJ
authors.lastname: Casey
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL.
authors.forename: A H
authors.initials: AH
authors.lastname: Santos
authors.affiliation: Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL.
authors.forename: A
authors.initials: A
authors.lastname: Hartzema
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL.
authors.forename: K L
authors.initials: KL
authors.lastname: Womer
mesh_terms: D000069594:Abatacept / Q000627:therapeutic use*; D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000601:surgery*; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000069594:Abatacept; D016559:Tacrolimus
keywords: calcineurin inhibitor: tacrolimus; fusion proteins and monoclonal antibodies: belatacept; glomerular filtration rate (GFR); graft survival; health services and outcomes research; immunosuppressant; immunosuppression/immune modulation; kidney transplantation/nephrology; rejection: acute