Date: Saturday, May 30, 2020
Session Name: Kidney Infections Excluding Polyoma & Viral Hepatitis
Session Time: 3:15pm-4:45pm
Presentation Time: 3:15pm-3:27pm
- The BEST Trial: A Prospective Randomized Multicenter Trial of Belatacept-Based CNI- and Corticosteroid-Free Immunosuppression
- Patient-Reported Outcomes in a Prospective Multicenter Trial of Belatacept-Based CNI- and Corticosteroid-Free Immunosuppression Regimens in Kidney Transplantation: A Prospective Analysis Across Two Years
*Purpose: The BEST Trial (Belatacept-based Early Steroid Withdrawal Trial) is a prospective, randomized, multi-center trial designed to compare two belatacept (BELA)-based calcineurin inhibitor-free (CNI), early corticosteroid withdrawal (ESW) regimens with a standard of care tacrolimus (TAC)-based ESW regimen. The purpose of this study was to compare infectious complications from BELA-based regimens to TAC-based regimens intention to treat, per protocol, and subgroup results.
*Methods: This study was conducted under an FDA IND and IRB approval at each of 8 sites. Adult kidney transplant recipients were eligible for enrollment. All patients received mycophenolate therapy and a five-day steroid taper. 315 patients were randomized to 3 treatment groups: alemtuzumab (Alem) + BELA (Group A), rATG + BELA (Group B), and rATG + TAC (Group C). All infections were collected as adverse events of special interest in this study and were analyzed by intent to treat and per protocol and then by subgroups of BPAR, AA race, BMI ≥ 30 and age ≥ 60.
*Results: Infection outcomes analyses at 24 months (end of study) are presented in tables 1 and 2.
*Conclusions: There were no significant differences in infection rates between the 3 treatment groups in either the intention to treat or per protocol analyses. BELA patients had numerically more BK viremia but less CMV viremia in comparison to TAC patients. Based on the subgroup analyses, the increase in viremia, specifically BK viremia, appears to be driven by BELA patients on r-ATG vs Alem and BELA patients experiencing BPAR or those with BMI ≥ 30. These results indicate that BELA-based regimens under ESW do not appear to increase the risk of infection in comparison to TAC-based regimens under corticosteroid withdrawal. A MVA of risk factors for infection is planned.
To cite this abstract in AMA style:West-Thielke P, Shields A, Kaufman D, Leone J, Wiseman A, Matas A, Sa T, King E, Alloway R, Woodle S. A Prospective Randomized Multicenter Trial (BEST Trial) of Belatacept-Based CNI- and Corticosteroid-Free Immunosuppression: Infectious Complications [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/a-prospective-randomized-multicenter-trial-best-trial-of-belatacept-based-cni-and-corticosteroid-free-immunosuppression-infectious-complications/. Accessed April 21, 2021.
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