06 Jun Kidney Transplant: Alternative Immunosuppressant Regimens with Belatacept (NULOJIX®) May Improve Outcomes
MedicalResearch.com Interview with:
Rita R. Alloway, PharmD, FCCP
Research Professor of Medicine
Director, Transplant Clinical Research
University of Cincinnati
College of Medicine, Department of Internal Medicine
Division of Nephrology
Kidney C.A.R.E. Program
(Clinical Advancement, Research & Education)
Cincinnati OH 45267
MedicalResearch.com: What is the background for this study?
Response: Transplant recipients are required to take lifelong immunosuppression to sustain the function of their transplant. Unfortunately these immunosuppressants have significant side effects. The most significant of these side effects are worsening kidney function, hypertension, hypercholesterolemia, post transplant diabetes, tremors and headaches. Researchers focused on improving post transplant outcomes are looking for immunosuppressant regimens with similar efficacy while minimizing harmful side effects.
Tacrolimus and steroids are the immunosuppressants associated with the worst side effect profiles. This study eliminated both of these immunosuppressants and replace tacrolimus with belatacept. Belatacept is a once monthly intravenous infusion with a more favorable side effect profile compared to tacrolimus. In addition, since it is a monthly infusion, adherence can improved compared to an oral medication taken twice daily.
MedicalResearch.com: What are the main findings?
Response: The immunosuppressant regimen containing belatacept provided similar efficacy in terms of patient and graft survival, slightly increased risk of rejection, but significantly improved renal function, adverse events and improved quality of life related to these adverse events as evidenced two years post transplant.
MedicalResearch.com: What should readers take away from your report?
Response: Alternative immunosuppressant regimens with belatacept may improve longterm post kidney transplant outcomes compared to the traditional immunosuppressant regimen used for over 25 years.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Of note, while the early success (1 year) of kidney transplant is very high, most kidney transplants do not continue to function after approximately 10 years. There are a variety of reasons why these grafts fail. Three of the main reasons are the formation of antibodies against the kidney, chronic kidney toxicity and nonadherence. Belatacept has a unique mechanism of action and has been associated with a significant reduction in antibody formation without causing kidney toxicity. Adherence with a once monthly infusion should be improved. Longer term followup of belatacept treated patients is required to discern longterm benefits.
MedicalResearch.com: Is there anything else you would like to add?
Response: Implementing novel immunosuppressive regimens which challenge the current clinical dogma are challenging and require a dedicated transplant team. The University of Cincinnati and UCHealth have such a team to conduct such novel trials to advance transplantation for the future while offering our local transplant patients novel immunosuppressive regimens up to 10 years sooner than other transplant centers.
Steve Woodle, MD is the sponsor and principal investigator of this study. Rita Alloway, PharmD and Adele Shields, PharmD are co-investigators and directors of the coordinating center.
Bristol Myers Squibb provide grant support for the study conduct
American Transplant Congress 2019 presentation discussing belatacept can help safely and effectively treat kidney transplant patients without traditional immunosuppressive regimens.
A Prospective Randomized Multicenter trial of Belatacept-based Cni-and Corticosteroid Immunosuppression: Final Two Year Results
D.B.Kaufman, et al
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