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. 2025 Oct;44(10):1612-1620.
doi: 10.1016/j.healun.2025.04.023. Epub 2025 May 28.

Efficacy and safety of belatacept in heart transplant recipients

Julia Baranowska  1 , Daniel Oren  1 , Andrea Fernandez Valledor  1 , Matan Uriel  1 , Changhee Lee  1 , Cathrine Maria Moeller  1 , Boaz Elad  1 , Salwa Rahman  1 , Adi Hertz  1 , Devin Skoll  1 , Matthew Regan  1 , Ersilia M DeFilippis  1 , Jayant Raikhelkar  1 , Justin Fried  1 , Dor Lotan  1 , Kyung Taek Oh  1 , David Bae  1 , Afsana Rahman  1 , Jason Choe  1 , Kevin Clerkin  1 , Adil A Yunis  1 , Melana Yuzefpolskaya  1 , Paolo C Colombo  1 , David Majure  2 , Farhana Latif  1 , Gabriel Sayer  1 , Nir Uriel  3
Affiliations

Efficacy and safety of belatacept in heart transplant recipients

Julia Baranowska et al. J Heart Lung Transplant. 2025 Oct.

Abstract

Background: Contemporary immunosuppressive regimens following heart transplantation (HT) are associated with nephrotoxicity. Additionally, some patients develop rejection despite standard immunosuppression, requiring augmentation. Belatacept (BTC) has demonstrated mortality and graft survival benefits while preserving renal function in kidney transplant recipients, but data regarding HT remain limited. This study aimed to evaluate the utilization, safety, and efficacy of BTC-based therapy in HT recipients, comparing outcomes with patients managed under a standard immunosuppression protocol.

Methods: This retrospective, single-center study evaluated all adult HT recipients treated with BTC between October 2019 and August 2023. Patients were stratified by indication (renal-sparing or enhanced immunosuppression) and propensity-matched to controls receiving standard immunosuppressive therapy. Primary outcomes were survival free from clinically significant rejection and changes in renal function post-BTC initiation.

Results: BTC was started in 64 patients at a median of 20 [IQR 7-66] months following transplant (37 renal-sparing, 27 immunological). Median age was 51 years and 59% were male. Over a median follow-up of 26 months, rejection free survival was similar between BTC patients and controls (P = 0.44). BTC initiation led to improved renal function, with an increase in GFR from 38 to 43 ml/min/1.73 m² (P = 0.04). Infections occurred in 20% of BTC patients. Epstein-Barr virus viremia occurred more frequently post-BTC initiation than before (40.6% vs 7.8%, P < 0.001). BTC treatment was associated with 98.5% 2-year survival.

Conclusions: BTC may safely be used as an adjunct immunosuppressive agent in HT recipients with renal dysfunction or elevated immunological risk. A BTC-based regimen is associated with improved renal function compared to a standard regimen based on calcineurin inhibitors.

Keywords: Belatacept; Heart transplantation; Immunosuppression; Rejection; Renal dysfunction.

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