The BEST Trial: A Prospective Randomized Trial of Belatacept-Based, CNI- and Corticosteroid-Free Immunosuppression.
1U Cincinnati, Cinci
2U Wisconsin, Madison
3Tampa General, Tampa
4U Minnesota, Minn
5U Colorado, Denver
6U Illinois Chicago, Chic.
Meeting: 2016 American Transplant Congress
Abstract number: B128
Keywords: Co-stimulation, Efficacy, Glomerular filtration rate (GFR), Induction therapy
Session Information
Session Name: Poster Session B: Drug Minimization
Session Type: Poster Session
Date: Sunday, June 12, 2016
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Halls C&D
Efficacy of CNI- and corticosteroid-free immunosuppressive regimens has not been demonstrated in large, multicenter trials. BEST (Belatacept-based Early Steroid Withdrawal Trial) (NCT 01729494) compares 2 belatacept (bela)-based early steroid withdrawal (ESW) regimens with a tacrolimus (TAC)-based ESW regimen. This is an interim report of aggregate results from the BEST Trial.
METHODS: The study is conducted under FDA IND115270 at 6 sites. Adult kidney transplant (KTx) patients (pts) were eligible except the following: extra-renal Tx, HLA identical living donor (LD), cPRA>50%, ECD KTx pts, Hepatitis B or C or HIV seropositivity, EBV seronegative pt. All pts received mycophenolate and 5 days of steroids. 315 pts will be randomized to 3 groups: thymoglobulin (rATG) + TAC, rATG + bela, or alemtuzumab + bela. Primary endpoint was a composite: death or graft loss (GL) or eGFR < 45ml/min.
RESULTS: Groups were reviewed in a blinded fashion by the DSMB on 3 occurrences. 241 pts were enrolled as of 11/15/15. Aggregate data on 215 pts with 2 months (mth) follow-up are presented:
| #Pts (%) | |
| Pts Analyzed | 215 |
| Active | 194 (90) |
| Withdrawn | 21 (10) |
| Rejection | 2 (1.0) |
| GL | 1 (0.5) |
| Death | 4 (1.9) |
| Mean Age (yrs) | 51.3 ± 13 |
| Male | 145 (68) |
| African American | 26 (12) |
| Preemptive Tx | 78 (36) |
| LD | 169 (79) |
| Primary Endpoint | |
| 6 mth | 28/169 (17) |
| 12 mth | 19/128 (15) |
| Death | |
| 6 mth |
3/169 (1.8) |
| 12 mth | 4/128 (3.1) |
| GL | |
| 6 mth | 3/169 (1.8) |
| 12 mth | 5/128 (3.9) |
| Death Censored GL | |
| 6 mth | 2/172 (1.2) |
| 12 mth | 3/140 (2.1) |
| eGFR < 45 mL/min | |
| 6 mth | 14/169 (16.6) |
| 12 mth | 14/128 (10.9) |
| Clinically Evident BPAR | |
| 6 mth | 15/172 (8.7) |
| 12 mth | 17/140 (12.2) |
| Clinically Silent BPAR | |
| 6 mth | 4/172 (2.3) |
| 12 mth | 7/172 (5) |
| Any Infection (Infx) | 120 (55.8) |
| Fungal Infx | 7 (3.3) |
| Viral Infx | 64 (29.8) |
| CMV Viremia | 21 (10) |
| BK Viremia | 27 (12.5) |
| BKV Nephropathy | 4 (2) |
| PTLD (kidney) | 1/215 (0.5) |
CONCLUSIONS: 1) BEST trial has exceeded 75% enrollment, 2) 2 prior DSMB meetings recommended ongoing enrollment, 3) primary and secondary endpoint rates are within expected ranges, 4) enrollment is expected to conclude in 2016.
CITATION INFORMATION: Woodle E, Kaufman D, Shields A, Leone J, Matas A, Wiseman A, Thielke P, Alloway R. The BEST Trial: A Prospective Randomized Trial of Belatacept-Based, CNI- and Corticosteroid-Free Immunosuppression. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:
Woodle E, Kaufman D, Shields A, Leone J, Matas A, Wiseman A, Thielke P, Alloway R. The BEST Trial: A Prospective Randomized Trial of Belatacept-Based, CNI- and Corticosteroid-Free Immunosuppression. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/the-best-trial-a-prospective-randomized-trial-of-belatacept-based-cni-and-corticosteroid-free-immunosuppression/. Accessed November 22, 2024.« Back to 2016 American Transplant Congress