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Publication Name World Journal of Gastroenterology
Manuscript ID 113505
Country United States
Category Gastroenterology & Hepatology
Manuscript Type Clinical Trials Study
Article Title Determination of correlation of clearance with clinical outcomes for inflammatory bowel disease
Manuscript Source Unsolicited Manuscript
All Author List Diane R Mould, Maximillian Kutschera, Christian Primas, Sieglinde Reinisch, Gottfried Novacek, Cornelia Lichtenberger, Thierry Dervieux, Yunju Bae, Sun Hee Lee, Joon Ho Lee and Walter Reinisch
Funding Agency and Grant Number
Corresponding Author Diane R Mould, PhD, Projections Research Inc, 535 Springview Lane, Phoenixville, PA 19460, United States. drmould@pri-home.net
Key Words Antidrug antibodies; Bayesian model-guided dosing; Clearance; Inflammatory bowel disease; Infliximab; Pharmacokinetics; Therapeutic drug monitoring
Core Tip There have been several evaluations of the relationship between therapeutic antibody clearance and outcomes. Data from a large study in patients administered infliximab at labeled dose were used to assess probability of antidrug antibodies, C-reactive protein normalization, and mucosal healing based on baseline clearance. A compassionate use study further evaluated these correlations, and clearance often decreased from baseline due to individualized dosing, suggesting improvements in the probability of all outcomes. While this study is small, the results are encouraging and suggest that further research on the use of clearance as a therapeutic endpoint is warranted in this area.
Citation Mould DR, Kutschera M, Primas C, Reinisch S, Novacek G, Lichtenberger C, Dervieux T, Bae Y, Lee SH, Lee JH, Reinisch W. Determination of correlation of clearance with clinical outcomes for inflammatory bowel disease. World J Gastroenterol 2025; In press
Received
2025-08-28 01:56
Peer-Review Started
2025-08-28 01:57
First Decision by Editorial Office Director
2025-09-04 10:47
Return for Revision
2025-09-04 10:47
Revised
2025-09-18 21:09
Publication Fee Transferred
2025-09-26 15:48
Second Decision by Editor
2025-12-15 02:45
Second Decision by Editor-in-Chief
Final Decision by Editorial Office Director
2025-12-15 09:43
Articles in Press
2025-12-15 09:43
Edit the Manuscript by Language Editor
Typeset the Manuscript
ISSN 1007-9327 (print) and 2219-2840 (online)
Open Access This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
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