A Validated LC-MS/MS Method for Performing Belatacept Drug Monitoring in Renal Transplantation

Biomedicines. 2023 Nov 1;11(11):2955. doi: 10.3390/biomedicines11112955.

Abstract

Belatacept, a CTLA4-Ig, was designed to prevent rejection and graft loss in kidney transplant recipients. This immunotherapy showed a long-term clinical benefit mainly on renal function and better glycemic control but was also associated with a higher number of severe infectious diseases, particularly CMV disease, and lymphoproliferative disease. Therapeutic drug monitoring usually guides the benefit-risk assessment of long-term immunosuppression. In this study, an analytical method by LC-MS/MS was developed in 20 microL of plasma for the belatacept quantification. Intra- and inter-assay precision and accuracy were lower than 20% for the limit of quantification, and 15% for higher concentrations. The method was implemented in our lab and provided data about the inter-variability (N = 108) and intra-variability (N = 33) of belatacept concentrations in kidney transplant recipients with a stable renal function, after conversion from a CNI- to a belatacept-based regimen.

Keywords: CTLA4-Ig; belatacept; kidney; pharmacokinetic; transplantation.

Grants and funding

This research received no external funding.