Drug Provides Better Kidney Transplant Survival Rates Than Current Standard Of Care
UCSF News reports on a clinical trial, BENEFIT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial) where for the first time, an immunosuppressive agent, Belatacept, showed better organ survival in kidney transplant recipients than a calcineurin inhibitor, the current standard of care. The study was reported on in the January 28th issue of the New England Journal of Medicine by lead author, Flavio Vincenti, MD, Clinical Professor of Medicine and Surgery in the Departments of Medicine and Surgery, and other researchers.
For the first time, an immunosuppressive agent has shown better organ survival in kidney transplant recipients than a calcineurin inhibitor, the current standard of care, according to a worldwide study led by UC San Francisco and Emory University investigators.
The study of the drug belatacept, which carries short-term risks that include an increased possibility for a certain cancer, appears in the Jan. 28 issue of the New England Journal of Medicine.
“Belatacept is potentially a transformational drug in kidney transplantation because unlike the currently used calcineurin inhibitor drugs cyclosporine and tacrolimus, it is not toxic to the kidney,” said lead author Flavio Vincenti, MD, a UCSF Health kidney and pancreas transplant specialist. “In fact, it helps preserve the function of the kidney over the long term and is more effective in suppressing antibodies against the kidney, which are important causes of late graft loss.”
Kidney transplant recipients need to take drugs to prevent their immune systems from rejecting their new organs, but the drugs themselves can cause problems. Long-term use of calcineurin inhibitors can damage the transplanted kidneys and lead to cardiovascular disease and diabetes.
Belatacept Inhibits Immune Response
A seven-year, multi-center study showed that kidney transplant recipients taking belatacept, a drug the U.S. Food and Drug Administration approved in 2011, experienced a rate of mortality and graft loss significantly lower than patients taking a calcineurin inhibitor-based regimen. The risk of death or loss of the transplanted kidney after seven years was 12.7 percent for belatacept, compared to 21.7 percent for cyclosporine A.
The study, called BENEFIT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial) and sponsored by Bristol-Myers Squibb, began in 2006, and FDA approval in 2011 was partly based on the first three years of results. Belatacept acts as a “co-stimulation blocker,” inhibiting one of two signals T cells needed to trigger an immune response.