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Belatacept-based immunosuppression with simultaneous calcineurin inhibitor avoidance and early corticosteroid withdrawal: A prospective, randomized multicenter trial.
Am J Transplant. 2020 04; 20(4):1039-1055.AJ

Abstract

Simultaneous calcineurin inhibitor avoidance (CNIA) and early corticosteroid withdrawal (ESW) have not been achieved primarily due to excessive acute rejection. This trial compared 2 belatacept-based CNIA/ESW regimens with a tacrolimus-based ESW regimen. Kidney transplant recipients were randomized to receive alemtuzumab/belatacept, rabbit anti-thymocyte globulin (rATG)/belatacept, or rATG/tacrolimus. The combinatorial primary endpoint consisted of patient death, renal allograft loss, or a Modification of Diet in Renal Disease-calculated eGFR of <45 mL/min/1.73 m2 at 12 months. Results are reported by treatment group (alemtuzumab/belatacept, rATG/belatacept, and rATG/tacrolimus). Superiority was not observed at 1 year for the primary endpoint (9/107 [8.4%], 15/104 [14.4%], and 14/105 [13.3%], respectively; P = NS) for either belatacept-based regimen. Differences were not observed for secondary endpoints (death, death-censored graft loss, or estimated glomerular filtration rates < 45 mL/min/1.73 m2). Differences were observed in biopsy-proved acute cellular rejection (10.3%, 18.3%, and 1.9%, respectively) (P < .001), but not in antibody-mediated rejection, mixed acute rejection, or de novo donor-specific anti-HLA antibodies. Neurologic and electrolyte abnormality adverse events were less frequent under belatacept. Belatacept-based CNIA/ESW regimens did not prove to be superior for the primary or secondary endpoints. Belatacept-treated patients demonstrated an increase in biopsy-proved acute cellular rejection and reduced neurologic and metabolic adverse events. These results demonstrate that simultaneous CNIA/ESW is feasible without excessive acute rejection.

Authors+Show Affiliations

University of Cincinnati College of Medicine, Cincinnati, Ohio.University of Wisconsin, Madison, Wisconsin.University of Cincinnati College of Medicine, Cincinnati, Ohio.Tampa General Hospital, Tampa, Florida.University of Minnesota, Minneapolis, Minnesota.University of Colorado, Denver, Colorado.University of Illinois-Chicago, Chicago, Illinois.Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio.University of Cincinnati College of Medicine, Cincinnati, Ohio. Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio.University of Cincinnati College of Medicine, Cincinnati, Ohio.No affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31680394

Citation

Woodle, E Steve, et al. "Belatacept-based Immunosuppression With Simultaneous Calcineurin Inhibitor Avoidance and Early Corticosteroid Withdrawal: a Prospective, Randomized Multicenter Trial." American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, vol. 20, no. 4, 2020, pp. 1039-1055.
Woodle ES, Kaufman DB, Shields AR, et al. Belatacept-based immunosuppression with simultaneous calcineurin inhibitor avoidance and early corticosteroid withdrawal: A prospective, randomized multicenter trial. Am J Transplant. 2020;20(4):1039-1055.
Woodle, E. S., Kaufman, D. B., Shields, A. R., Leone, J., Matas, A., Wiseman, A., West-Thielke, P., Sa, T., King, E. C., & Alloway, R. R. (2020). Belatacept-based immunosuppression with simultaneous calcineurin inhibitor avoidance and early corticosteroid withdrawal: A prospective, randomized multicenter trial. American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 20(4), 1039-1055. https://doi.org/10.1111/ajt.15688
Woodle ES, et al. Belatacept-based Immunosuppression With Simultaneous Calcineurin Inhibitor Avoidance and Early Corticosteroid Withdrawal: a Prospective, Randomized Multicenter Trial. Am J Transplant. 2020;20(4):1039-1055. PubMed PMID: 31680394.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Belatacept-based immunosuppression with simultaneous calcineurin inhibitor avoidance and early corticosteroid withdrawal: A prospective, randomized multicenter trial. AU - Woodle,E Steve, AU - Kaufman,Dixon B, AU - Shields,Adele R, AU - Leone,John, AU - Matas,Arthur, AU - Wiseman,Alexander, AU - West-Thielke,Patricia, AU - Sa,Ting, AU - King,Eileen C, AU - Alloway,Rita R, AU - ,, Y1 - 2020/02/06/ PY - 2019/07/12/received PY - 2019/10/18/revised PY - 2019/10/23/accepted PY - 2019/11/5/pubmed PY - 2019/11/5/medline PY - 2019/11/5/entrez KW - clinical research/practice KW - costimulation KW - immunosuppressant - fusion proteins and monoclonal antibodies: belatacept KW - immunosuppressant - steroid KW - immunosuppression/immune modulation KW - immunosuppressive regimens - induction KW - immunosuppressive regimens - minimization/withdrawal KW - kidney transplantation/nephrology SP - 1039 EP - 1055 JF - American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons JO - Am. J. Transplant. VL - 20 IS - 4 N2 - Simultaneous calcineurin inhibitor avoidance (CNIA) and early corticosteroid withdrawal (ESW) have not been achieved primarily due to excessive acute rejection. This trial compared 2 belatacept-based CNIA/ESW regimens with a tacrolimus-based ESW regimen. Kidney transplant recipients were randomized to receive alemtuzumab/belatacept, rabbit anti-thymocyte globulin (rATG)/belatacept, or rATG/tacrolimus. The combinatorial primary endpoint consisted of patient death, renal allograft loss, or a Modification of Diet in Renal Disease-calculated eGFR of <45 mL/min/1.73 m2 at 12 months. Results are reported by treatment group (alemtuzumab/belatacept, rATG/belatacept, and rATG/tacrolimus). Superiority was not observed at 1 year for the primary endpoint (9/107 [8.4%], 15/104 [14.4%], and 14/105 [13.3%], respectively; P = NS) for either belatacept-based regimen. Differences were not observed for secondary endpoints (death, death-censored graft loss, or estimated glomerular filtration rates < 45 mL/min/1.73 m2). Differences were observed in biopsy-proved acute cellular rejection (10.3%, 18.3%, and 1.9%, respectively) (P < .001), but not in antibody-mediated rejection, mixed acute rejection, or de novo donor-specific anti-HLA antibodies. Neurologic and electrolyte abnormality adverse events were less frequent under belatacept. Belatacept-based CNIA/ESW regimens did not prove to be superior for the primary or secondary endpoints. Belatacept-treated patients demonstrated an increase in biopsy-proved acute cellular rejection and reduced neurologic and metabolic adverse events. These results demonstrate that simultaneous CNIA/ESW is feasible without excessive acute rejection. SN - 1600-6143 UR - https://www.unboundmedicine.com/medline/citation/31680394/Belatacept_based_immunosuppression_with_simultaneous_calcineurin_inhibitor_avoidance_and_early_corticosteroid_withdrawal:_A_prospective_randomized_multicenter_trial_ L2 - https://doi.org/10.1111/ajt.15688 DB - PRIME DP - Unbound Medicine ER -
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