SAN FRANCISCO, Jan. 28 (UPI) — The drug belatacept, sold as Nulojix, showed better organ survival in kidney transplant recipients than the current standard of care, according to a multi-year, worldwide study.
Researchers at Emory University and the University of California San Francisco found the drug slashed the risk of death or organ rejection nearly in half of transplant patients over the course of the seven-year study.
Belatacept, which was approved by the U.S. Food and Drug Administration in 2011, was better at preserving kidney function over the long term and more effectively suppressed antibodies against the transplanted organs than the standard calcineurin inhibitor drugs. The FDA approval was based on the first three years of data from the new study, researchers said.
Although calcineurin inhibitor drugs can help prevent the body from attacking a transplanted organ, over time they can damage kidneys, as well as lead to cardiovascular disease and diabetes.
“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,” said Dr. Christian Larsen, a professor of surgery at Emory University, in a press release.
For the study, published in the New England Journal of Medicine, researchers recruited 666 transplant patients, assigning them to one of three post-operative treatment groups: a more intensive belatacept regimen, a less intensive belatacept regimen, and a standard-care cyclosporine regimen. Patients were followed for seven years of treatment after transplantation.
Among patients treated with either belatacept regimen, the risk of death or organ rejection went down by 43 percent, as compared with patients taking cyclosporine. The risk of death or loss of the transplant after seven years for patients treated with belatacept was 12.7 percent, compared to 21.7 percent for patients treated with cyclosporine.
“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 Dr. Flavio Vincenti, a health kidney and pancreas transplant specialist at the University of California San Francisco, in a press release, adding that researchers “are still learning how best to use belatacept in immunosuppression regimens to balance its long-term benefits with greater safety and efficacy in the short term.”