Real-world evidence regarding cancer, mortality, and graft failure risk with de novo belatacept use among kidney transplant recipients in the United States

Shyfuddin Ahmed; Ruth M. Pfeiffer; Karena Volesky-Avellaneda; Christopher D. Blosser; Jon J. Snyder; Ajay K. Israni; Charles F. Lynch; Baozhen Qiao; Judy R. Rees; Fiona Zwald; Kelly J. Yu; Eric A. Engels

doi:10.1016/j.ajt.2025.03.004

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Real-world evidence regarding cancer, mortality, and graft failure risk with de novo belatacept use among kidney transplant recipients in the United States

Journal article

Peer reviewed

Real-world evidence regarding cancer, mortality, and graft failure risk with de novo belatacept use among kidney transplant recipients in the United States

Shyfuddin Ahmed, Ruth M. Pfeiffer, Karena Volesky-Avellaneda, Christopher D. Blosser, Jon J. Snyder, Ajay K. Israni, Charles F. Lynch, Baozhen Qiao, Judy R. Rees, Fiona Zwald, …

American journal of transplantation, Vol.25(8), pp.1723-1734

08/2025

DOI: 10.1016/j.ajt.2025.03.004

PMCID: PMC12310376

PMID: 40064297

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https://pmc.ncbi.nlm.nih.gov/articles/PMC12310376/View

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Abstract

Belatacept is a selective T-cell co-stimulation blocker used in maintenance immunosuppression for kidney transplant recipients (KTRs), but evidence on cancer risk and other outcomes is limited. This retrospective cohort study used linked US transplant and cancer registry data on KTRs treated with belatacept (N=1514) or tacrolimus (N=7570) as initial maintenance therapy. We used multivariable Cox regression models to compare incidence of invasive cancer, cutaneous squamous cell carcinoma (cSCC), posttransplant lymphoproliferative disorder (PTLD), death, and graft failure/retransplantation (GF/RT) between belatacept and tacrolimus users. Overall, cancer incidence was 10.1 and 12.6 per 1000 person-years in belatacept and tacrolimus users, respectively. We did not find increased risk with belatacept for cancer overall (adjusted hazard ratio [HR] 0.83, 95% confidence interval [95%CI] 0.53-1.30), individual cancer types, or cSCC. Belatacept was associated with increased risk of death (adjusted HR 1.22, 95%CI 1.04-1.43) but lower risk of GF/RT more than four years after transplantation (0.54, 0.35-0.83). PTLD risk was increased among EBV-seropositive KTRs (adjusted HR 1.96, 95%CI 1.03-3.73). This study provides reassurance that belatacept does not increase cancer risk among KTRs, and there was a long-term protective association for GF/RT. However, we found evidence suggesting a potential increased risk of PTLD and death with belatacept use.

Epstein-Barr Virus

belatacept

cancer

kidney transplantation

mortality

posttransplant lymphoproliferative disorders

squamous cell carcinoma

Details

Title: Subtitle: Real-world evidence regarding cancer, mortality, and graft failure risk with de novo belatacept use among kidney transplant recipients in the United States
Creators: Shyfuddin Ahmed - National Cancer Institute
Ruth M. Pfeiffer - National Cancer Institute
Karena Volesky-Avellaneda - Division of Cancer Epidemiology and Genetics
Christopher D. Blosser - University of Washington
Jon J. Snyder - Hennepin Healthcare Research Institute
Ajay K. Israni - The University of Texas Medical Branch at Galveston
Charles F. Lynch - University of Iowa
Baozhen Qiao - New York State Department of Health
Judy R. Rees - Dartmouth College
Fiona Zwald - University of Colorado Denver
Kelly J. Yu - National Cancer Institute
Eric A. Engels - National Cancer Institute
Resource Type: Journal article
Publication Details: American journal of transplantation, Vol.25(8), pp.1723-1734
DOI: 10.1016/j.ajt.2025.03.004
PMID: 40064297
PMCID: PMC12310376
NLM abbreviation: Am J Transplant
ISSN: 1600-6135
eISSN: 1600-6143
Publisher: Elsevier Inc
Language: English
Electronic publication date: 03/08/2025
Date published: 08/2025
Academic Unit: Epidemiology
Record Identifier: 9984799686302771

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