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, C. Berger 1Immundiagnostik AG, Bensheim, Germany Search for other works by this author on: Oxford Academic J. Semmler 1Immundiagnostik AG, Bensheim, Germany Search for other works by this author on: Oxford Academic J. Ruppert 1Immundiagnostik AG, Bensheim, Germany Search for other works by this author on: Oxford Academic H. Schulze 2Agaplesion Markus Krankenhaus, Frankfurt/Main, Germany Search for other works by this author on: Oxford Academic F.-P. Armbruster 1Immundiagnostik AG, Bensheim, Germany Search for other works by this author on: Oxford Academic A. Dignass 2Agaplesion Markus Krankenhaus, Frankfurt/Main, Germany 3Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt/Main, Germany Search for other works by this author on: Oxford Academic J. Stein 3Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt/Main, Germany 4DGD Clinics Sachsenhausen, Frankfurt/Main, Germany Search for other works by this author on: Oxford Academic
Journal of Crohn's and Colitis, Volume 11, Issue suppl_1, February 2017, Page S320, https://doi.org/10.1093/ecco-jcc/jjx002.599
Published:
26 January 2017
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C. Berger, J. Semmler, J. Ruppert, H. Schulze, F.-P. Armbruster, A. Dignass, J. Stein, P474 An enzyme-linked immunosorbent assay for therapeutic drug monitoring of vedolizumab, Journal of Crohn's and Colitis, Volume 11, Issue suppl_1, February 2017, Page S320, https://doi.org/10.1093/ecco-jcc/jjx002.599
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Abstract
Background: Vedolizumab (VLZ), an α4β7 integrin antagonist, is a therapeutic monoclonal antibody recently approved for use in moderate to severe ulcerative colitis (UC) and Crohn's disease (CD). Part of the interindividual differences in response to VLZ treatment may be explained by interindividual variability in pharmaco*kinetics.
Methods: Microtiter plates were coated with anti-VLZ specific monoclonal antibody. Samples diluted 1:200 were added on a microtiter plate for specific binding, and bound VLZ was detected using mouse anti-human immunoglobulin G1 (HRP-anti h IgG1). Trough serum concentrations of VLZ were analyzed in 86 samples of 21 adult UC patients and compared to concentrations measured by in-house developed LC-MS/MS assay (Christ et al., J Crohn's Colitis 2016, S1).
Results: The limit of quantification (LoQ) for VLZ determination in human serum samples was 0.0071 μg/mL. The intra-assay variation (n=20) was 8.57% for 9.55 μg/mL and 6.54% for 18.9 μg/mL. The inter-assay variation (n=40) was 7.10% for 28.5 μg/mL and 8.33% for 35.7 μg/mL. Linearity testing of the ELISA was performed by analysis of two serially diluted patient samples; the coefficients of variation (CV%) were below 8%. No false positive signals were detected in samples spiked with TNFα blockers (infliximab, adalimumab, golimumab). In the samples of patients treated with VLZ the trough level ranged from 0.02 to 71.01 μg/mL. VLZ results of ELISA and an in-house developed LC-MS/MS assay showed a correlation coefficient (r) of 0.96 (Fig. 1).
Figure 1
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Conclusions: This newly developed ELISA method is rapid, accurate and reproducible, and may be useful for pharmaco*kinetic-pharmacodynamic studies, as well as in therapeutic drug monitoring of vedolizumab.
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© 2017 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com
Topic:
- enzyme-linked immunosorbent assay
- integrins
- crohn's disease
- ulcerative colitis
- adult
- monoclonal antibodies
- bone plates
- immunoglobulins
- mice
- pharmaco*kinetics
- pharmacodynamics
- therapeutic drug monitoring
- infliximab
- antagonists
- adalimumab
- crohn's colitis
- trough concentration
- serum specimen
- false-positive results
- golimumab
- vedolizumab
Issue Section:
Abstracts > Clinical: Therapy and observation
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