학술논문

A Validated LC-MS/MS Method for Performing Belatacept Drug Monitoring in Renal Transplantation
Document Type
article
Source
Biomedicines, Vol 11, Iss 11, p 2955 (2023)
Subject
belatacept
CTLA4-Ig
transplantation
kidney
pharmacokinetic
Biology (General)
QH301-705.5
Language
English
ISSN
2227-9059
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.