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Early Adalimumab and Anti‐Adalimumab Antibody Levels for Prediction of Primary Nonresponse in Ankylosing Spondylitis Patients

This study aimed at exploring the concentration‐effect relationship of adalimumab and early adalimumab and anti‐adalimumab antibody (AAA) levels in predicting primary nonresponse in a real‐world pilot cohort of patients with ankylosing spondylitis. Thirty‐one patients were included. The Ankylosing S...

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Autores principales: Ding, Xiaoliang, Zhu, Ruifang, Wu, Jian, Xue, Ling, Gu, Meihua, Miao, Liyan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214645/
https://www.ncbi.nlm.nih.gov/pubmed/31961477
http://dx.doi.org/10.1111/cts.12738
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author Ding, Xiaoliang
Zhu, Ruifang
Wu, Jian
Xue, Ling
Gu, Meihua
Miao, Liyan
author_facet Ding, Xiaoliang
Zhu, Ruifang
Wu, Jian
Xue, Ling
Gu, Meihua
Miao, Liyan
author_sort Ding, Xiaoliang
collection PubMed
description This study aimed at exploring the concentration‐effect relationship of adalimumab and early adalimumab and anti‐adalimumab antibody (AAA) levels in predicting primary nonresponse in a real‐world pilot cohort of patients with ankylosing spondylitis. Thirty‐one patients were included. The Ankylosing Spondylitis Disease Activity Score improved with increasing adalimumab trough level at week 12 and reached a major improvement with levels between 8 and 12 μg/mL. Moreover, weeks 4 and 2 adalimumab levels below 4.28 and 3.37 μg/mL were predictive of primary nonresponse (area under the curve (AUC) = 0.89, 0.88; P = 0.0003, P = 0.034, respectively). Week 4 AAA signal‐to‐noise levels were significantly higher among primary nonresponders, and the cutoff for primary nonresponse prediction was above 5.31 (AUC = 0.81; P = 0.004). Adalimumab trough levels in a range of 8–12 μg/mL are optimum to reach major improvement, and lower adalimumab with higher AAA levels at the early stage (week 4) predict primary nonresponse by supporting proactive monitoring to optimize adalimumab therapy.
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spelling pubmed-72146452020-05-13 Early Adalimumab and Anti‐Adalimumab Antibody Levels for Prediction of Primary Nonresponse in Ankylosing Spondylitis Patients Ding, Xiaoliang Zhu, Ruifang Wu, Jian Xue, Ling Gu, Meihua Miao, Liyan Clin Transl Sci Research This study aimed at exploring the concentration‐effect relationship of adalimumab and early adalimumab and anti‐adalimumab antibody (AAA) levels in predicting primary nonresponse in a real‐world pilot cohort of patients with ankylosing spondylitis. Thirty‐one patients were included. The Ankylosing Spondylitis Disease Activity Score improved with increasing adalimumab trough level at week 12 and reached a major improvement with levels between 8 and 12 μg/mL. Moreover, weeks 4 and 2 adalimumab levels below 4.28 and 3.37 μg/mL were predictive of primary nonresponse (area under the curve (AUC) = 0.89, 0.88; P = 0.0003, P = 0.034, respectively). Week 4 AAA signal‐to‐noise levels were significantly higher among primary nonresponders, and the cutoff for primary nonresponse prediction was above 5.31 (AUC = 0.81; P = 0.004). Adalimumab trough levels in a range of 8–12 μg/mL are optimum to reach major improvement, and lower adalimumab with higher AAA levels at the early stage (week 4) predict primary nonresponse by supporting proactive monitoring to optimize adalimumab therapy. John Wiley and Sons Inc. 2020-02-13 2020-05 /pmc/articles/PMC7214645/ /pubmed/31961477 http://dx.doi.org/10.1111/cts.12738 Text en © 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research
Ding, Xiaoliang
Zhu, Ruifang
Wu, Jian
Xue, Ling
Gu, Meihua
Miao, Liyan
Early Adalimumab and Anti‐Adalimumab Antibody Levels for Prediction of Primary Nonresponse in Ankylosing Spondylitis Patients
title Early Adalimumab and Anti‐Adalimumab Antibody Levels for Prediction of Primary Nonresponse in Ankylosing Spondylitis Patients
title_full Early Adalimumab and Anti‐Adalimumab Antibody Levels for Prediction of Primary Nonresponse in Ankylosing Spondylitis Patients
title_fullStr Early Adalimumab and Anti‐Adalimumab Antibody Levels for Prediction of Primary Nonresponse in Ankylosing Spondylitis Patients
title_full_unstemmed Early Adalimumab and Anti‐Adalimumab Antibody Levels for Prediction of Primary Nonresponse in Ankylosing Spondylitis Patients
title_short Early Adalimumab and Anti‐Adalimumab Antibody Levels for Prediction of Primary Nonresponse in Ankylosing Spondylitis Patients
title_sort early adalimumab and anti‐adalimumab antibody levels for prediction of primary nonresponse in ankylosing spondylitis patients
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214645/
https://www.ncbi.nlm.nih.gov/pubmed/31961477
http://dx.doi.org/10.1111/cts.12738
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