A study published in the New England Journal of Medicine (NEJM) found that an immunosuppressive drug called belatacept improved long-term outcomes following kidney transplantation, compared to a traditional standard-of-care regimen.
Drugs that suppress the immune system are required after kidney transplant to prevent the new organ from being rejected. However, traditional standard-of-care immunosuppressants have potential toxic effects which may damage the new kidney and lead to cardiovascular disease. Furthermore, data on patient outcomes of immunosuppressive therapy beyond five years are limited. A team of researchers led by Christian P. Larsen, MD, PhD, Emory University School of Medicine Dean and Professor of Surgery, and Flavio Vincenti, MD, a transplant specialist at University of San Francisco, carried out an international clinical trial called BENEFIT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial) to determine if treatment with belatacept improved patient and organ survival, and kidney function in those who received a kidney transplant, compared to a traditional standard-of-care medication, called cyclosporine. Participants were randomly assigned to receive a more-intensive belatacept regimen, a less-intensive belatacept regimen, or cyclosporine. This study reports the long-term outcomes of these therapies on 447 participants with available data after seven years.
Compared to the standard-of-care cyclosporine regimen, both the more-intensive and less-intensive belatacept regimens were associated with a 43% reduction in risk of patient death or organ rejection, after seven years. Additionally, both belatacept regimens were associated with improvements in kidney function, whereas kidney function tended to decrease in those who received cyclosporine. “While research is ongoing to further define the ideal uses for belatacept, these results suggest that belatacept may safely and effectively improve patient outcomes after kidney transplantation,” says Larsen. Read more about this study at the Emory News Center.
BENEFIT was funded by Bristol-Myers Squibb, and Emory investigators utilized the services of the Georgia CTSA Clinical Research Centers (GCRCs) to assist in carrying out the study. “The GCRCs nursing staff was immensely helpful in carrying out the BENEFIT study by assisting with the belatacept infusions in the Emory Transplant Center infusion suite,” said Elizabeth Ferry, RN, CCRC, research nurse supervisor in the Emory Transplant Center Clinical Research Program, and the Emory University Hospital study site coordinator for BENEFIT.
The Georgia CTSA Clinical Research Centers (GCRCs) is a multilayered, flexible, and geographically distributed network created to meet the needs of translational and clinical investigators from Emory, Morehouse School of Medicine (MSM), and Georgia Institute of Technology (Georgia Tech). The GCRCs includes nearly 35 clinical research sites across the city incorporating hospital, medical office, and community-based clinical research sites, such as Emory University Hospital, Emory Midtown Hospital, Grady Memorial Hospital, Children’s Health Care of Atlanta, the Ponce Infectious Diseases Clinic, the Hope Clinic, Wesley Woods Health Center, and the Morehouse School of Medicine Clinical Research Center.
The ACTSI is a city-wide partnership between Emory, Morehouse School of Medicine, and Georgia Tech and is one of over 60 in a national consortium striving to improve the way biomedical research is conducted across the country. The consortium, funded through the National Center for Advancing Translational Sciences (NCATS) and the National Institutes of Health’s Clinical and Translational Science Awards, shares a common vision to translate laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train the next generation of clinical investigators.