Effect of tacrolimus exposure on everolimus-based immunosuppression in de novo kidney transplant recipients: A 24-month analysis from transform study
Recommended Citation
Citterio F, Peddi V, Qazi Y, Kim D, Vincenti F, Berger S, Sommerer C, Gawai A, Hernandez-Gutierrez M, Bernhardt P, Oberbauer R. Effect of tacrolimus exposure on everolimus-based immunosuppression in de novo kidney transplant recipients: A 24-month analysis from transform study. Transpl Int 2021; 34(SUPPL 1):254-255.
Document Type
Conference Proceeding
Publication Date
8-27-2021
Publication Title
Transpl Int
Abstract
Background: Long-term use of calcineurin inhibitors including tacrolimus (TAC) has been associated with nephrotoxicity and infections. Here, we evaluated the efficacy and safety of everolimus+reduced-dose TAC (EVR+r-TAC) versus mycophenolic acid+standard-dose TAC (MPA+sTAC) by TAC subgroups, from TRANSFORM (NCT01950819) study. Methods: Patients were stratified within treatment arms, based on mean TAC trough levels (C0) from week 1 to month (M) 2, into below (<4 &<8 ng/mL), within (4-7 &8-12 ng/mL) and above (>7 &> 12 ng/mL) the target range in EVR and MPA arms, respectively. Composite of treated biopsy-proven acute rejection (tBPAR)/graft loss/death and individual components, renal function estimated glomerular filtration rate (eGFR), and infections were evaluated up to M24. Results: Incidence of composite efficacy failure was higher in EVR+rTAC versus MPA+sTAC arm (p = .125) among patients above TAC target C0. In EVR+rTAC arm significantly higher incidence of tBPAR (p = .016), acute rejection (p = .003), and acute antibody-mediated rejection (p <.001) was observed in patients with TAC C0 above target range. In patients within TAC target C0, all efficacy endpoints were comparable in EVR+rTAC versus MPA+sTAC arm. Incidences of BPAR and tBPAR were significantly lower (p <.001) in EVR+rTAC versus MPA+sTAC arm in patients below TAC target C0. At M24, no significant difference in creatinine or eGFR was observed across TAC subgroups. Cytomegalovirus and BK virus infection rates were significantly lower among patients below and within TAC target C0 (p <.001) in EVR+rTAC arm. Incidence of de novo donor specific antigen was comparable in both arms across TAC subgroups (Table). Conclusions: Better anti-rejection efficacy could be achieved with lower TAC exposure in EVR arm while higher TAC exposure was required with MPA. EVR+rTAC offered comparable renal function and lower viral infections versus MPA+sTAC regimen up to M24 posttransplant among subgroup of patients within TAC target C0.
Volume
34
Issue
SUPPL 1
First Page
254
Last Page
255
