Background: Belatacept is approved for the prophylaxis of organ rejection in Epstein-Barr virus (EBV)-seropositive kidney transplant recipients and is associated with a risk of post-transplant lymphoproliferative disorder (PTLD).
Methods: Data from the Organ Procurement and Transplantation Network were used to examine patterns of belatacept use, describe patient characteristics, and estimate risk of PTLD in EBV-seropositive, kidney-only transplant recipients receiving belatacept- or calcineurin inhibitor (CNI)-based immunosuppression as part of US Food and Drug Administration-mandated safety monitoring.
Results: During the study period (June 15, 2011-June 14, 2016), 94.9% (1631/1719) of belatacept-treated and 89.7% (59,992/66,905) of CNI-treated patients with known EBV serostatus were EBV seropositive. Among EBV-seropositive patients, 50.2% (belatacept) and 56.8% (CNI) received a standard criteria donor kidney, 59.5% and 18.7% received basiliximab induction, and 22.9% and 50.8% received antithymocyte globulin induction. PTLD developed in nine belatacept-treated patients (two with central nervous system [CNS] involvement) and 225 CNI-treated patients (nine with CNS involvement). Four and 81 patients, respectively, died due to PTLD. Kaplan-Meier analysis did not show a significant between-group difference in PTLD estimated incidence rates within 5 years (0.70% versus 0.48%, respectively; p = 0.18). Additionally, estimated PTLD incidence was not significantly different between treatment groups in a propensity score matched cohort.
Conclusions: The majority of adult kidney-only transplant recipients treated with belatacept in routine clinical practice are EBV seropositive. In this study, the risk of PTLD in these patients, while higher than for CNI-based immunosuppression, remained low after adjusting for differences in patient characteristics.
Trial Registration: These studies are registered at ClinicalTrials.gov: NCT01670058 and NCT01656343.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11723631 | PMC |
| http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0311935 | PLOS |
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