Recent preliminary clinical trial results indicate the immunosuppressive drug belatacept can safely and effectively treat kidney transplant patients without adverse long-term side effects of traditional immunosuppressive regimens. Belatacept was approved by the U.S. Food and Drug Administration in 2011 for the prevention of immune rejection in kidney transplant patients and is the modified form of another drug called abatacept which treats rheumatoid arthritis.
The clinical trial is known as the Belatacept Early Steroid Withdrawal Trial (BEST) represented a significant step forward in enhancing the quality of life for postoperative patients receiving kidney transplantation.
"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, William A. Altemeier Professor in Research Surgery at the UC College of Medicine and director of Solid Organ Transplantation for UC Health."We wanted to reduce the side effects and toxicities of these medications and make it easier for patients to tolerate their anti-rejection drugs, while achieving rejection rates that are reasonable, this work solved a vexing 40-year-old problem and represents a major step forward in the field of transplantation."
Findings of the two-year study did not utilize the long-term use of prednisone (a corticosteroid) or tacrolimus (a calcineurin inhibitor).
"The primary problem that has prevented elimination of corticosteroids and calcineurin inhibitors to date has been excessive rejection rates," stated Rita Alloway, PharmD, research professor of nephrology at the UC College of Medicine and director of Transplant Clinical Research at UC Health. "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."
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The standard care of treatment for patients who receive a kidney transplant is a post-surgery regimen involving corticosteroid and calcineurin inhibitor (CNI) immunosuppressants. These drugs have long been known to help organ transplant patients survive but can result in kidney toxicity or cardiovascular damage.
"This CNI- and steroid-free [immunosuppressive] protocol is a promising step forward in minimizing toxicities and improving renal allograft function," noted the author of the study. "Longer-term observations will need to be continued."
Source: University of Cincinnati
