New protocol means half the medication with similar results
Emory Transplant Center recently completed a randomized interventional study of post-kidney transplant recipients that examined dosing intervals for belatacept immunosuppression therapy. Emory is currently the only institution in the state of Georgia that offers post-kidney transplant patients belatacept. The current standard of care for post-transplant kidney patients who have completed a transient course of tacrolimus treatment that usually ends around 9-12 months post-transplant is to continue with monthly infusions of belatacept.
For the study, stable patients on belatacept at least one year post-kidney transplant and off tacrolimus transitioned from the standard monthly infusion to an investigational every other month dosing schedule.
Preliminary results show promise with study patients’ renal function and acute rejection rates being similar to those receiving the standard dosing schedule.
Benefits of Fewer Infusions
Because belatacept is a biologic with a long-lasting mechanism of action, transplant physicians believe patients can go lengthier periods without having to re-dose. Changing the dosage from monthly to every two months means not only increased convenience for patients, fewer logistical challenges and barriers to access; it also reduces the cost for patients and the health care system. Additionally, when patients receive identical benefits from half the dosage, their potential risk of infectious or malignant complications from long-term immunosuppression is lowered as well.
About the Study
In 2015, a group of post-transplant patients who were stable and at low immunologic risk were put into one of two arms of the study. In the standard-of-care arm, patients continued their monthly infusions of belatacept; in the study’s intervention arm, the infusions were spaced every two months. The study was completed in late summer of 2019 and is currently in the analysis phase. Investigators are optimistic about the results and anticipate that Emory will adopt the every-two-month belatacept infusion regimen as standard protocol for eligible patients sometime in 2020.
With a better history of patient and organ survival than calcineurin inhibitors such as cyclosporine and tacrolimus – the previous standard of care – belatacept helps preserve long-term organ function. Belatacept also suppresses antibodies more effectively, helping guard against late graft loss, and is not toxic to the kidneys. Prolonged use of calcineurin inhibitors can harm transplanted organs and increase a patient’s risk of heart disease and diabetes.
Emory doctors had a vital role in both discovering belatacept and moving it toward development. Emory has participated in several studies, including Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT), which began in 2006. A multi-center study that lasted seven years, BENEFIT demonstrated that kidney transplant recipients taking belatacept experienced a 43% reduction in the risk of graft loss and patient death compared with those on the study’s cyclosporine regimen.
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