Determination of secukinumab in human plasma by ELISA method and application in psoriasis patients
10.12092/j.issn.1009-2501.2024.11.008
- VernacularTitle:酶联免疫法检测司库奇尤单抗血药浓度及在银屑病患者中的应用
- Author:
Youai DAI
1
;
Kouzhu ZHU
;
Yan WANG
;
Zhou LU
;
Xiaoliang DING
;
Lei WANG
Author Information
1. 南京医科大学附属无锡人民医院器官移植实验室,无锡 214023,江苏
- Publication Type:Journal Article
- Keywords:
secukinumab;
therapeutic drug moni-toring;
ELISA;
psoriasis
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2024;29(11):1267-1271
- CountryChina
- Language:Chinese
-
Abstract:
AIM:To develop and validate an ELISA method for the determination of secukinumab(SEC)in human plasma and apply it in psoriasis pa-tients.METHODS:A double-antibody sandwich ELI-SA was developed using anti-secukinumab anti-body as the capture antibody and biotin-labeled an-ti-secukinumab antibody as the detection antibody.The method was systematically validated.Nineteen patients with Psoriasis treated with standard dose of SEC were included.In order to determine trough concentrations of SEC,steady-state blood samples were collected after 24 weeks of treatment.Psoria-sis area and severity index score was used to evalu-ate the response.RESULTS:The SEC concentration showed a good concentration-response relation-ship within the range of 1.25 to 80.00 μg/mL.The intra-batch and inter-batch precision and accuracy were ≤ 15.00％,and there was no hook effect in the range of 1.25 to 1 000 μg/mL.The median trough concentrations of 19 patients was 33.56 μg/mL(IQR:32.55-45.98 μg/mL)with an inter-individu-al variation of 52.00％for body weight adjusted concentration of SEC.The SEC concentrations were not significantly different between the active group and remission group(P=0.92).CONCLUSION:We developed and validated a method for the determi-nation of SEC,which can be used for therapeutic drug monitoring in patients receiving SEC therapy.However the inter-individual variation is large.Fur-ther study is needed to explore the association of SEC levels with clinical response in Psoriasis.
