Although tacrolimus is the basis of most maintenance immunosuppression regimens for kidney transplantation, concerns about toxicity have made alternative agents, such as belatacept, attractive to clinicians. However, limited data exist to directly compare outcomes with belatacept-based regimens to tacrolimus.
We performed a propensity score matched cohort study of adult kidney transplant recipients transplanted between May 1, 2001, and December 31, 2015, using national transplant registry data to compare patient and allograft survival in patients discharged from their index hospitalization on belatacept-based versus tacrolimus-based regimens.
In the primary analysis, we found that belatacept was not associated with a statistically significant difference in risk of patient death (hazard ratio, 0.84; 95% confidence interval [CI], 0.61-1.15, P = 0.28) or allograft loss (hazard ratio, 0.83; 95% CI, 0.62-1.11; P = 0.20) despite an increased risk of acute rejection in the first year posttransplant (odds ratio, 3.12; 95% CI, 2.13-4.57; P < 0.001). These findings were confirmed in additional sensitivity analyses that accounted for use of belatacept in combination with tacrolimus, transplant center effects, and differing approaches to matching.
Belatacept appears to have similar longitudinal risk of mortality and allograft failure compared with tacrolimus-based regimens. These data are encouraging but require confirmation in prospective randomized controlled trials.
This propensity-score, matched-cohort study including adult kidney transplant recipients suggests that patients discharged from their index hospitalization on belatacept show similar risk of mortality and allograft failure compared to those receiving tacrolimus-based regimens despite increased risk of acute rejection. Supplemental digital content is available in the text.
1 Renal Electrolyte and Hypertension Division, Department of Medicine, University of Pennsylvania, Philadelphia, PA.
2 Department of Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA.
3 Division of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, PA.
4 Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Received 18 August 2016. Revision received 21 October 2016.
Accepted 31 October 2016.
This work was supported in part by Heath Resources and Service Administration contract 234-2005-370011C. The content is the responsibility of the authors alone and does not necessarily reflect the view or policies of the Department of Health and Human Services nor does mention of trade names, commercial products or organizations imply endorsement by the US Government.
Research reported in this publication was supported by the National Heart, Lung, And Blood Institute (JC: K23HL133843) and the National Institute of Diabetes and Digestive and Kidney Diseases (KF: K23DK090209) of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
The authors declare no conflicts of interest.
J.B.C. and K.C.E. contributed equally to this article.
J.B.C., K.C.E. participated in the conception or design of the work, analysis and interpretation of data, drafting, and revision of the article. K.A.F. participated in the conception or design of the work, interpretation of data, drafting, and revision of the article. P.L.A. participated in the conception or design of the work, drafting and revision of the article. D.S. participated in the conception or design of the work, interpretation of data, drafting and revision of the article.
Correspondence: Deirdre Sawinski, MD, 1 Founders Pavilion, 3400 Spruce Street, Philadelphia, PA 19104. (Deirdre.firstname.lastname@example.org).
Supplemental digital content (SDC) is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.transplantjournal.com).