Belatacept Provides Better Kidney Transplant Survival Rates Than Current Standard of Care
Chris Larsen and Tom Pearson
A study of kidney transplant recipients has shown for the first time that belatacept, which controls the immune system and prevents graft rejection, has a better record of patient and organ survival than a calcineurin inhibitor (CNI), previously the standard of care.
Emory University School of Medicine dean and kidney and pancreas transplant surgeon Christian Larsen, MD, DPhil, played a key role in developing belatacept, together with Emory Transplant Center executive director and Livingston Professor of Surgery Thomas Pearson, MD, DPhil. Belatacept was approved by the FDA in 2011 and is produced by Bristol Myers Squibb. Results from the worldwide study, led by Dr. Larsen and UCSF kidney transplant surgeon and Endowed Chair in Kidney Transplantation Flavio Vincenti, MD, was published in the Jan. 28 issue of the New England Journal of Medicine.
Kidney transplant recipients need to take medications to prevent their immune systems from rejecting their new organs, but the drugs can cause problems. Long-term use of CNIs can damage the transplanted kidneys and lead to cardiovascular disease and diabetes.
Belatacept acts as a "co-stimulation blocker," inhibiting one of two signals T cells needed to trigger an immune response. Belatacept carries short-term risks that include an increased possibility for a certain cancer, and research continues at Emory on the best regimens for kidney transplant patients.
"While the best uses of belatacept still need additional definition, these results indicate that using belatacept as standard of care has the potential to improve long-term outcomes that matter to patients," says Dr. Larsen.
"Belatacept is potentially a transformational drug in kidney transplantation because unlike the currently used CNIs cyclosporine and tacrolimus, it is not toxic to the kidney," Dr. Vincenti says. "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."
The study, called BENEFIT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial), was sponsored by Bristol-Myers Squibb and began in 2006. FDA approval of belatacept in 2011 was partly based on the first three years of results.
The seven-year, multi-center study showed that kidney transplant recipients taking belatacept experienced a rate of mortality and graft loss significantly lower than patients taking a CNI-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.
Post-transplant drugs can cost tens of thousands of dollars per year, and a belatacept-based regimen is more expensive than one based on CNIs. Many U.S. insurance companies now cover belatacept as medically necessary for kidney transplant patients. Belatacept is given by infusion monthly at a doctor's office, in contrast to CNIs, which are taken in daily pills at home.
Click here for more information and additional results from the study.