A study of kidney transplant recipients has shown for the first time that the drug belatacept (Nulojix), which controls the immune system and prevents graft rejection, has a better record of patient and organ survival than a calcineurin inhibitor, the current standard of care.
Patients who have undergone kidney transplant are required to take medications to prevent their immune systems from rejecting their new organs. A calcineurin inhibitor (CNIs) is generally used for post kidney transplant patients, but long-term use can damage transplanted kidneys and may lead to cardiovascular disease and diabetes.
Belatacept acts as a “co-stimulation blocker,” inhibiting one of two signals the T cells need to trigger an immune response. And unlike the currently used CNIs, it is not toxic to the kidney. 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 organ loss.
Emory University School of Medicine Dean and kidney and pancreas transplant surgeon, Dr. Christian Larsen, played a key role in developing belatacept, together with Emory Transplant Center Executive Director and Livingston Professor of Surgery, Dr. Thomas Pearson. Belatacept was approved by the FDA in 2011 and is produced by Bristol Myers Squibb.
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. Results from the worldwide study, led by Dr. Larsen and University of California San Francisco kidney transplant surgeon, Dr. Flavio Vincenti, were published in the Jan. 28 issue of the New England Journal of Medicine.
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.
“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 given by infusion monthly at a doctor’s office, in contrast to CNIs, which are taken in daily pills at home. Many U.S. insurance companies now cover belatacept as medically necessary for kidney transplant patients.