期刊名称：Journal of Clinical Biochemistry and Nutrition
印刷版ISSN：0912-0009
电子版ISSN：1880-5086
出版年度：2022
卷号：70
期号：1
页码：72-78
DOI：10.3164/jcbn.21-98
语种：English
出版社：The Society for Free Radical Research Japan
摘要：Vedolizumab is a humanized monoclonal antibody against the α4β7 integrin and is approved for treatment of inflammatory bowel diseases. In this study, we evaluated the immunogenicity of vedolizumab using a simple drug-tolerant assay developed in our laboratory. Serum vedolizumab trough levels and anti-vedolizumab antibody (AVA) levels were measured using new immunoassays in 37 patients with ulcerative colitis (UC) under vedolizumab maintenance therapy. The median vedolizumab trough level at week 30 was 16.0 μg/ml (interquartile range, 7.3–24.4). The vedolizumab trough level of the patients with clinical remission (partial Mayo score ≤1) was significantly higher than that of clinically active patients (16.7 μg/ml vs 6.8). The cut-off value of vedolizumab level predicting clinical remission at week 30 was 7.34 μg/ml. The median AVA level of patients under vedolizumab maintenance therapy was similar to that of healthy controls (
n = 20) (0.032 μg/ml-c vs 0.022). One of 37 patients (2.7%) was judged to be AVA positive. There was no significant difference in serum AVA and vedolizumab trough levels between biologics-naïve (
n = 19) and biologics-switched (prior anti-TNFα-exposed) patients (
n = 18). In conclusion, the simple drug-tolerant assay developed in our laboratory demonstrated low immunogenicity of vedolizumab. Prior use of anti-TNFα drugs did not affect the immunogenicity of vedolizumab.
关键词：envedolizumabanti-vedolizumab antibodytherapeutic drug monitoring
