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Belatacept is a second-generation cytotoxic T-lymphocyte-associated antigen-4-Ig fusion protein, which down-regulates T-cell response, and is used in the prophylaxis of organ rejection in adults receiving a kidney transplant. This article reviews the pharmacologic properties of belatacept and its clinical efficacy and tolerability in kidney transplant recipients.
In the well designed, phase III trials BENEFIT and BENEFIT-EXT (in patients receiving kidneys from living/standard-criteria or extended-criteria donors, respectively), a belatacept-based treatment regimen was noninferior to a cyclosporine (ciclosporin)-based regimen with regard to patient and graft survival and acute graft rejection rate, and was significantly superior to the cyclo-sporine-based regimen with regard to the rate of renal impairment (in BENEFIT only), at 12 months.
Belatacept-based treatment showed long-term efficacy and remained effective after 2, 3, and 4 years with regard to these endpoints.
Belatacept was generally well tolerated in patients with kidney transplants from living, standard-criteria, or extended-criteria donors. The most serious adverse events that have been reported with belatacept treatment are post-transplant lymphoproliferative disorder, other malignancies, and serious infections.
At month 12, the incidence of new-onset diabetes mellitus after transplant was significantly lower with belatacept than with cyclosporine, and belatacept recipients had significantly lower blood pressure and a significantly smaller increase in certain lipid levels than cyclosporine recipients.
KeywordsCyclosporine Kidney Transplant Acute Rejection Mycophenolate Mofetil Abatacept
Acknowledgments and Disclosures
The manuscript was reviewed by: A. B. Jain, Department of Surgery, Temple University Hospital, Philadelphia (PA), USA; M. Naesens, Department of Nephrology and Renal Transplantation, University Hospital Leuven, Leuven, Belgium; L. L. Rostaing, Department of Nephrology, Hemodialysis and Transplantation, CHU Toulouse, Toulouse, France.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.
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