Belatacept-versus Cyclosporine-Based Immunosuppression in Renal Transplant Recipients with Pre-existing Diabetes

Rostaing, Lionel; Neumayer, Hans H.; Reyes‐Acevedo, Rafael; Bresnahan, Barbara A.; Florman, Sander; Vı́tko, Štefan; Heifets, Michael; Xing, Jun; Thomas, Dolca; Vincenti, Flavio

doi:10.2215/cjn.00270111

Cited by 30 publications

(20 citation statements)

References 27 publications

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“…However, belatacept-treated patients had better preservation of kidney function with a higher GFR than the cyclosporine-treated patients. In diabetic patients, there was an increase in patient and graft survival with belatacept, but this did not achieve statistical significance (Rostaing et al 2011). In each of the studies, there was an increased risk of PTLD with belatacept.…”

Section: Costimulatory Blockadementioning

confidence: 82%

“…A number of trials have reported the outcomes of belatacept-based immunosuppression protocols in comparison to cyclosporine-based regimens. One-and 3-year outcomes have shown similar graft and patient survival between cyclosporine and belatacept protocols, but slightly more rejection with belatacept (Durrbach et al 2010;Vincenti et al 2010;Rostaing et al 2011;Pestana et al 2012). However, belatacept-treated patients had better preservation of kidney function with a higher GFR than the cyclosporine-treated patients.…”

Section: Costimulatory Blockadementioning

confidence: 97%

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Tolerance--Is It Worth It?

Finger

Strom

Matas

2013

Cold Spring Harbor Perspectives in Medicine

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We are entering an exciting time in the study of immunologic tolerance. Several cellular and molecular strategies have been developed that show promise in nonhuman transplant models and these approaches are just now appearing in clinical trials. Tolerance strategies that prevent immune rejection and obviate the need for immunosuppressive medications (with inherent risk of cancer, infection, and organ toxicity) would improve both graft and patient survival. Each tolerance protocol brings its own set of associated risks. As the results of these trials become available, we must continue to evaluate their successes and failures. The balance of these outcomes will help us answer the question: "Tolerance-Is it worth it?"WHAT IS TOLERANCE?

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Section: Costimulatory Blockadementioning

confidence: 82%

Section: Costimulatory Blockadementioning

confidence: 97%

Tolerance--Is It Worth It?

Finger

Strom

Matas

2013

Cold Spring Harbor Perspectives in Medicine

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“…Based on the clinical course and biopsy findings, both cases clearly show that the poor renal function was due to TAC therapy. Belatacept has been studied extensively recently in kidney transplant patients (8)(9)(10)(11)(12). Treatment with belatacept is associated with better renal function, less CAN and an improved cardiovascular risk factor profile compared with cyclosporine.…”

Section: Discussionmentioning

confidence: 99%

“…Belatacept, the first selective T cell costimulation blocker approved to prevent acute rejection in adult renal transplant recipients does not cause nephrotoxicity. Recent studies comparing regimens in which belatacept was used to either replace or reduce the dose of the CNI have shown success in low risk kidney transplant recipients (8,9). Furthermore, switching patients maintained on a CNI-based regimen to a belatacept-based regimen was shown to be effective in preventing the progression of kidney allograft dysfunction from CNI toxicity (10).…”

Section: Introductionmentioning

confidence: 99%

Conversion From Tacrolimus to Belatacept to Prevent the Progression of Chronic Kidney Disease in Pancreas Transplantation: Case Report of Two Patients

Mujtaba

Sharfuddin

Taber

et al. 2014

American Journal of Transplantation

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y Both authors contributed equally.Belatacept is a novel immunosuppressive agent that may be used as an alternative to calcineurin inhibitors (CNI) in immunosuppression (IS) regimens. We report two cases of pancreas transplant that were switched from tacrolimus (TAC) to belatacept. Case 1: 38-yearold female with pancreas transplant alone maintained on TAC-based IS regimen whose serum creatinine (SCr) slowly deteriorated from 0.6 mg/dL at baseline to 2.2 mg/dL, 16 months posttransplant. A native kidney biopsy performed showed CNI toxicity. The patient was started on belatacept and TAC was eliminated. Case 2: 49-year-old female with simultaneous pancreas-kidney transplant, maintained on TAC-based regimen where the SCr worsened over an initial 3-month period from a baseline of 1.0 to 3.0 mg/dL. Belatacept was started and TAC was lowered. Due to persistent graft dysfunction and kidney transplant biopsy still showing changes consistent with CNI toxicity, the TAC was then discontinued. At >1 year postbelatacept and off TAC follow-up, kidney function as measured by SCr remains stable at 1.0 AE 0.2 mg/dL in both recipients. Neither patient developed rejection following the switch, and pancreas allograft function remains stable in both recipients.

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“…17 Patients were considered to have diabetes before transplantation if they reported a medical history of diabetes or were taking insulin or oral antidiabetic medication at the time of transplantation. At Figure 4 Mean eGFR in the BENEFIT-EXT study.…”

Section: Phase III Benefit-ext Studiesmentioning

confidence: 99%

Belatacept for the prophylaxis of organ rejection in kidney transplant patients: an evidence-based review of its place in therapy

Hardinger¹,

Sunderland²,

Wiederrich³

2016

IJNRD

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Background: Belatacept is a novel immunosuppressive therapy designed to improve clinical outcomes associated with kidney transplant recipients while minimizing use of calcineurin inhibitors (CNIs). Methods: We searched for clinical trials related to administration of belatacept to kidney transplant patients compared to various immunosuppression regimens, as well as for studies that utilized data from belatacept trials to validate new surrogate measures. The purpose of this review is to consolidate the published evidence of belatacept's effectiveness and safety in renal transplant recipients to better elucidate its place in clinical practice. Results: Analysis of the results from the Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppressive Trial (BENEFIT) study, a de novo trial that compared cyclosporine (CsA)-based therapy to belatacept-based therapy in standard criteria donors, found a significant difference in mean estimated glomerular filtration rate (eGFR) of 13-15 mL/ min/1.73 m 2 and 23-27 mL/min/1.73 m 2 at 1 year and 7 years, respectively. The BENEFIT-EXT study was similarly designed with the exception that it included extended criteria donors. Renal function improved significantly for the more intensive belatacept group in all years of the BENEFIT-EXT study; however, it was not significant in the less intensive group until 5 years after transplant. Belatacept regimens resulted in lower blood pressure, cholesterol levels, and incidence of new-onset diabetes after transplant compared to CsA-based regimens. Results from conversion of CNIs to belatacept therapy, dual therapy of belatacept with sirolimus, and belatacept with corticosteroid avoidance therapy are also included in this article. Conclusion:The evidence reviewed in this article suggests that belatacept is an effective alternative in kidney transplant recipients. Compared to CNI-based therapy, belatacept-based therapy results in superior renal function and similar rates of allograft survival. In terms of safety, belatacept was shown to have lower incidence of hypertension, hyperlipidemia, and diabetes; however, incidence of posttransplantation lymphoproliferative disorder and the cost of belatacept may hinder use of this medication.

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Belatacept-versus Cyclosporine-Based Immunosuppression in Renal Transplant Recipients with Pre-existing Diabetes

Cited by 30 publications

References 27 publications

Tolerance--Is It Worth It?

Tolerance--Is It Worth It?

Conversion From Tacrolimus to Belatacept to Prevent the Progression of Chronic Kidney Disease in Pancreas Transplantation: Case Report of Two Patients

Belatacept for the prophylaxis of organ rejection in kidney transplant patients: an evidence-based review of its place in therapy

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