학술논문

Avoidance of CNI and steroids using belatacept—Results of the Clinical Trials in Organ Transplantation 16 trial
Document Type
article
Source
American Journal of Transplantation. 20(12)
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Clinical Trials and Supportive Activities
Organ Transplantation
Rare Diseases
Clinical Research
Transplantation
Kidney Disease
Evaluation of treatments and therapeutic interventions
6.1 Pharmaceuticals
Renal and urogenital
Abatacept
Graft Rejection
Graft Survival
Immunosuppressive Agents
Kidney Transplantation
Steroids
clinical research
practice
immunosuppression
immune modulation
kidney transplantation
nephrology
clinical trial
costimulation
immunosuppressant ‐
fusion proteins and monoclonal antibodies
belatacept
rejection
T cell–
mediated
clinical research/practice
immunosuppressant - fusion proteins and monoclonal antibodies: belatacept
immunosuppression/immune modulation
kidney transplantation / nephrology
rejection: T cell-mediated
Medical and Health Sciences
Surgery
Clinical sciences
Immunology
Language
Abstract
Immunosuppression devoid of corticosteroids has been investigated to avoid long-term comorbidities. Likewise, alternatives to calcineurin inhibitors have been investigated as a strategy to improve long-term kidney function following transplanion. Costimulatory blockade strategies that include corticosteroids have recently shown promise, despite their higher rates of early acute rejection. We designed a randomized clinical trial utilizing depletional induction therapy to mitigate early rejection risk while limiting calcineurin inhibitors and corticosteroids. This trial, Clinical Trials in Organ Transplantation 16 (CTOT-16), sought to evaluate novel belatacept-based strategies employing tacrolimus and corticosteroid avoidance. Sixty-nine kidney transplant recipients were randomized from 4 US transplant centers comparing a control group of with rabbit antithymocyte globulin (rATG) induction, rapid steroid taper, and maintenance mycophenolate and tacrolimus, to 2 arms using maintenance belatacept. There were no graft losses but there were 2 deaths in the control group. However, the trial was halted early because of rejection in the belatacept treatment groups. Serious adverse events were similar across groups. Although rejection was not uniform in the belatacept maintenance therapy groups, the frequency of rejection limits the practical implementation of this strategy to avoid both calcineurin inhibitors and corticosteroids at this time.