Comparative Effectiveness and Harms of Belatacept Versus Tacrolimus Among Kidney Transplant Recipients in The United States
Year: 2026
Type: dissertation
Study design: Observational Study
Abstract: Few studies have compared the effectiveness and harms of initiating belatacept versus tacrolimus for immunosuppression among kidney transplant recipients. We conducted a cohort study emulating a target trial using data from the United States Renal Data System and the Scientific Registry of Transplant Recipients. We included adult Medicare beneficiaries (≥18 years) undergoing first kidney transplantation in the U.S. from 2012-2020 who initiated belatacept or tacrolimus at transplant (intention-to-treat analysis). Effectiveness outcomes included a primary composite (death or graft failure), rejection at 1 year and 2 years, and kidney function assessed using estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) at 6 months, 1 year and 2 years. Harm outcomes included post-transplantation diabetes mellitus, cardiac ischemic events (composite of acute myocardial infarction or revascularization procedures), post-transplantation lymphoproliferative disorders (PTLD), and mortality at 1 and 2 years. We standardized tacrolimus initiators to belatacept initiators using propensity score-derived weights. For all outcomes except mortality and eGFR, we estimated adjusted risk differences (aRD) and risk ratios (aRR) using weighted Aalen-Johansen estimators. For mortality, we used weighted Kaplan-Meier estimators to estimate aRD and aRR. For eGFR, we used generalized estimating equations to calculate weighted mean-differences.The cohort included 30,678 recipients, 870 initiating belatacept and 29,808 initiating tacrolimus. At 2 years, There was no evidence of between-group differences for the primary composite (12.15% versus 12.28%, aRD= -0.13%, 95% CI (-2.72%, 2.47%)). Compared with tacrolimus initiators, belatacept initiators had a higher risk of rejection (37.46% versus 24.54%, aRD= 12.91%, 95% CI (7.95%, 17.54%)). The weighted mean eGFR (ml/min/1.73m2) was 51.68 versus 50.01, differences=1.66; 95% CI (-0.94, 4.27)). Belatacept initiators had a lower incidence of post-transplantation diabetes mellitus (21.63% versus 26.80%, aRD= -5.17%, 95% CI (-9.81%, -0.43%) and a higher incidence of PTLD (3.73% versus 2.07%, aRD= 1.66%, 95% CI 0.21%, 3.03%). There were no differences in cardiac ischemic events (5.29% versus 5.38%, aRD= -0.10%, 95% CI -1.96%, 1.80%) or mortality (7.31% versus 6.83%, aRD= 0.47%, 95% CI-1.68%, 2.63%). Our findings provide real-world evidence on the comparative benefits and harms of belatacept versus tacrolimus initiation among kidney transplant recipients and may inform clinician-patient shared decision-making when selecting maintenance immunosuppression.
DOI: 10.17615/aj94-c266
Institution: University of North Carolina at Chapel Hill
Language: English
Subfield: Transplantation
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7162799734
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