Every two-month belatacept maintenance therapy in kidney transplant recipients greater than one-year post-transplant: a randomized, non-inferiority trial.Badell, I. R., et al.
American Journal of Transplantation 2021 [record in progress].
The aim of this study was to determine whether the administration of belatacept every two months was noninferior to standard monthly dosing in kidney transplant patients with low immunologic risk.
Participants were randomly assigned to receive belatacept therapy every month (q1m) or every two months (q2m).
166 renal transplant patients.
The primary endpoint was the assessment of estimated glomerular filtration rate (eGFR) at 12 months. The secondary endpoints included patient death, graft loss, rejection, the incidence of infections, and formation of donor-specific antibodies (DSA).
This well-designed study randomised stable, low risk renal transplant recipients > 1 year post-transplant to once-monthly or once every 2 month belatacept. The study was conducted on a non-inferiority basis, and the authors found that 2-monthly belatacept resulted in non-inferior 12-month eGFR supporting less frequent dosing in these patients. There were numerically more acute rejection episodes in the 2-monthly arm, which the authors ascribe to non-adherent behavior. There is the possibility of detection bias – for safety reasons, the patients in the 2-monthly arm had more frequent lab tests for the 4 months after switching regimens. Nonetheless, this perhaps highlights the importance of careful assessment of patient adherence when considering a regimen such as this, as the potential consequence of missed doses will be greater than more frequent dosing.
ClinicalTrials.gov - NCT02560558