The Efficacy and Safety of Belatacept in Heart Transplant Recipients

Uriel, M.; Oren, Daniel; Yopes, Margot C.; Clerkin, Kevin J.; Raikhelkar, J.; Fried, Justin; Griffin, Jan M.; Gaine, M.; Restaino, Susan; Lee, S.; Choe, Julie C; Jennings, Douglas L.; Topkara, V.K.; Takeda, Koji; Naka, Y.; Majure, D.; Yuzefpolskaya, M.; Colombo, Paolo; Latif, F.; Uriel, Nir; Sayer, Gabriel; Habal, Marlena V.

doi:10.1016/j.healun.2022.01.1400

Cited by 3 publications

(6 citation statements)

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“…There has been one published case report and two retrospective studies examining its use as maintenance therapy in adult heart transplant recipients. In these studies, belatacept was used to preserve renal function or to treat elevated donor‐specific antibodies 14–16 . In contrast to the monthly dosing of BAS administered to our cohort, recommendations for belatacept dosing include more frequent administration (weekly or every 2 weeks) in the initial period, then spaced to monthly intervals thereafter.…”

Section: Discussionmentioning

confidence: 99%

“…In the largest retrospective review including 776 adults, belatacept therapy resulted in improved kidney function, lower rejection rate, and preserved graft function. However, infection was a common complication (33.3%), and 19% of patients discontinued therapy due to adverse effects 16 . Belatacept is contraindicated in patients who have an unknown EBV status or are EBV seronegative due to significantly increased risk of developing PTLD 17 .…”

Section: Discussionmentioning

confidence: 99%

“…In these studies, belatacept was used to preserve renal function or to treat elevated donor-specific antibodies. [14][15][16] In contrast to the monthly dosing of BAS administered to our cohort, recommendations for belatacept dosing include more frequent administration (weekly or every 2 weeks) in the initial period, then spaced to monthly intervals thereafter. In the largest retrospective review including 776 adults, belatacept therapy resulted in improved kidney function, lower rejection rate, and preserved graft function.…”

Section: Discussionmentioning

confidence: 99%

“…However, infection was a common complication (33.3%), and 19% of patients discontinued therapy due to adverse effects. 16 Belatacept is contraindicated in patients who have an unknown EBV status or are EBV seronegative due to significantly increased risk of developing PTLD. 17 Notably, our patient cohort included 2 patients with chronic EBV viremia and 1 additional patient with a history of PTLD.…”

Section: Discussionmentioning

confidence: 99%

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Basiliximab as maintenance immunosuppression in heart transplant recipients: A single pediatric center experience

Chen

Greene

Everitt

et al. 2022

Pediatric Transplantation

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Background: Pediatric heart transplant recipients are at risk for complications from prolonged exposure to immunosuppressive drugs, pharmacokinetic challenges in maintaining consistent immunosuppression, and medication non-adherence.Basiliximab (BAS), an interleukin-2 receptor antagonist, is used for induction therapy across many pediatric heart transplant centers, but use as maintenance immunosuppression has not been well described.Methods: This was a retrospective, single pediatric center cohort study of heart transplant recipients who received BAS for maintenance immunosuppression (defined as >2 monthly doses) from January 1, 2011, to December 31, 2021.Results: Ten patients met study criteria with a median age of 17.5 (5-22) years and median 9.6 (1.2-18.9) years since transplant at time of BAS initiation. The primary indications for BAS use were recurrent rejection (n = 4), fluctuating immunosuppression levels (n = 3), and renal dysfunction (n = 3). A median of 5.5 (3-32) monthly BAS doses were received. Three patients had a rejection event while on BAS. Calcineurin inhibitor exposure was reduced in 70% of patients. Three of the 10 patients were alive at last follow-up. There was one documented infection during BAS use, and no hypersensitivity reactions. Conclusions:Monthly BAS infusions were well tolerated and allowed for reduced calcineurin inhibitor exposure in most patients. Mortality commonly occurred despite BAS use, potentially reflecting the acuity of this patient cohort. BAS can be considered for maintenance immunosuppression in pediatric patients with fluctuating immunosuppressive levels and/or renal dysfunction. More studies are needed to determine long-term outcomes and explore expanded use of BAS in the pediatric heart transplant population.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Basiliximab as maintenance immunosuppression in heart transplant recipients: A single pediatric center experience

Chen

Greene

Everitt

et al. 2022

Pediatric Transplantation

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“…15 However, in HTx recipients, only limited evidence from small studies reporting on the safety of belatacept is available. [16][17][18]…”

Section: Relation To Previous Workmentioning

confidence: 99%

Drug levels after sirolimus initiation and short‐term outcomes in ambulatory heart transplantation recipients

Kancharla,

Kugathasan,

McDonald

et al. 2023

Clinical Transplantation

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IntroductionWe evaluated the effect of relative changes in combined tacrolimus and sirolimus (drug) levels, following sirolimus initiation, on outcomes in ambulatory heart transplantation (HTx) recipients.MethodsWe performed a retrospective analysis of HTx recipients who received tacrolimus, followed by sirolimus initiation, any time after HTx. We calculated the relative change in combined drug levels 1‐month post‐sirolimus initiation, relative to tacrolimus levels pre‐initiation, and categorized patients into decreased (≥15% decrease), stable (<15% decrease to <15% increase), or increased (≥15% increase) groups. We compared, across the three groups, changes in post‐initiation estimated glomerular filtration rate (eGFR) and left ventricular ejection fraction (LVEF) using one‐way ANOVA and Šidák's post‐hoc analysis, as well as the individual and composite outcomes of new donor specific antibodies (DSA), acute cellular rejection (ACR), and all‐cause mortality using Fisher's exact test.ResultsAmongst 99 HTx recipients included, the median age was 53 years, time to sirolimus initiation was 1.5 years post‐HTx, and pre‐sirolimus eGFR was 52 mL/min/1.73 m2. Nine patients had decreased, 15 stable, and 75 increased, relative combined drug levels. Relative change in eGFR was significantly higher in patients with decreased levels compared to patients with increased levels at 6 months post‐initiation (P < .05), but this was not sustained at 12 months. There were no differences in LVEF change or in individual and composite risks for developing DSA, ACR, and all‐cause mortality at 12 months across the groups.ConclusionPost‐sirolimus initiation, a relative decrease in combined drug levels, compared to increased levels, was associated with temporarily improved renal function.

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Belatacept

2022

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The Efficacy and Safety of Belatacept in Heart Transplant Recipients

Cited by 3 publications

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Basiliximab as maintenance immunosuppression in heart transplant recipients: A single pediatric center experience

Basiliximab as maintenance immunosuppression in heart transplant recipients: A single pediatric center experience

Drug levels after sirolimus initiation and short‐term outcomes in ambulatory heart transplantation recipients

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