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New drug regimens improve kidney transplant outcomes

Preliminary results from a $5.2 million clinical trial led by UC researchers show that the immunosuppressive drug Belatacept can help safely and effectively treat kidney transplant patients without the negative long-term side effects of traditional immunosuppressive regimens.

The UC-led Belatacept Early Steroid Withdrawal Trial (BEST) represents a significant step forward in the science of how not only to save lives through kidney transplantation, but also how to prolong the lives and improve the quality of life for those patients for decades after surgery.

“In the BEST trial, we tried to achieve something that hadn’t been done in transplantation: to eliminate the use of corticosteroids very early after surgery and at the same time avoid the toxicities associated with the cornerstone immunosuppressive medications that had been used for four decades,” said principal investigator E. Steve Woodle, MD, director of Solid Organ Transplantation.

The study’s two-year findings were presented by BEST investigators in several scientific sessions of the annual American Transplant Congress in Boston. Additional findings related to the study were presented by study authors, including Rita Alloway, PharmD, director of Transplant Clinical Research.

“The primary problem that has prevented elimination of corticosteroids and calcineurin inhibitors to date has been excessive rejection rates,” Alloway said. “The BEST Trial demonstrates that rejection risk with the new belatacept-based regimens was increased somewhat, and the reduced side effects and long-term cardiovascular risk reduction are major potential advantages of these regimens for the future.”

For the 16,000 people who receive a kidney transplant in the U.S. each year, the standard of care involves a post-surgery regimen that includes corticosteroid and calcineurin inhibitor (CNI) immunosuppressants—drugs that for decades have helped organ transplant patients live, but can also come with long-term effects such as kidney toxicity or cardiovascular damage.

The BEST study is the first large, multicenter trial to remove both corticosteroids and CNIs from a patient’s drug regimen after kidney transplantation. Both drugs place patients at an increased risk of cardiovascular disease, high blood pressure, high cholesterol and diabetes. CNIs have also shown toxicity to transplanted kidneys.

The study was funded by Bristol Myers Squibb (BMS), the manufacturer of Belatacept.