Belatacept-based immunosuppression with simultaneous calcineurin inhibitor avoidance and early corticosteroid withdrawal: A prospective, randomized multicenter trial.

Autor: Woodle ES; University of Cincinnati College of Medicine, Cincinnati, Ohio., Kaufman DB; University of Wisconsin, Madison, Wisconsin., Shields AR; University of Cincinnati College of Medicine, Cincinnati, Ohio., Leone J; Tampa General Hospital, Tampa, Florida., Matas A; University of Minnesota, Minneapolis, Minnesota., Wiseman A; University of Colorado, Denver, Colorado., West-Thielke P; University of Illinois-Chicago, Chicago, Illinois., Sa T; Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio., King EC; University of Cincinnati College of Medicine, Cincinnati, Ohio.; Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio., Alloway RR; University of Cincinnati College of Medicine, Cincinnati, Ohio.
Jazyk: angličtina
Zdroj: American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons [Am J Transplant] 2020 Apr; Vol. 20 (4), pp. 1039-1055. Date of Electronic Publication: 2020 Feb 06.
DOI: 10.1111/ajt.15688
Abstrakt: 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 m 2 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 m 2 ). 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.
(© 2019 The American Society of Transplantation and the American Society of Transplant Surgeons.)
Databáze: MEDLINE
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