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©The Author(s) 2026. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 7, 2026; 32(5): 113505
Published online Feb 7, 2026. doi: 10.3748/wjg.v32.i5.113505
Published online Feb 7, 2026. doi: 10.3748/wjg.v32.i5.113505
Determination of correlation of clearance with clinical outcomes for inflammatory bowel disease
Diane R Mould, Projections Research Inc., Phoenixville, PA 19460, United States
Maximillian Kutschera, Christian Primas, Sieglinde Reinisch, Gottfried Novacek, Cornelia Lichtenberger, Walter Reinisch, Department of Internal Medicine III, Division Gastroenterology and Hepatology, Medical University of Vienna, Vienna 1090, Austria
Thierry Dervieux, Prometheus Labs, San Diego, CA 92121, United States
Yunju Bae, Sun Hee Lee, Joon Ho Lee, Medical Science Division, Celltrion Inc., Incheon 22014, South Korea
Author contributions: Mould DR and Reinisch W were involved in the conceptualization, data curation, formal analysis, investigation, methodology, original draft preparation, writing, review, and editing; Kutschera M, Pimas C, Novacek G, Reinisch S, and Lichtenberger C were involved in data collection, review, and editing; Dervieux T provided analytical assistance and participated in writing, review, and editing; Bae Y, Lee SH, and Lee JH provided CT-P13 data and participated in writing, review, and editing.
Institutional review board statement: For the CT-P13 study (ClinicalTrials.gov No. NCT02096861), the study protocol was approved by Independent Ethics Committees for each study center, the study was conducted in line with the Declaration of Helsinki, International Conference on Harmonization Good Clinical Practice guidelines, and all applicable regulatory requirements, and all patients provided written informed consent, as previously reported. For the compassionate use program at the Department of Gastroenterology and Hepatology, Medical University of Vienna, the Institutional Review Board of the Medical University of Vienna advised that up to 10 patients could be treated in line with the Austrian Medicinal Products Act. All patients provided informed consent prior to treatment.
Clinical trial registration statement: CT-P13 was registered with ClinicalTrials.gov No. NCT02096861.
Informed consent statement: Both CT-P13 and the compassionate use study collected informed consent from all participants.
Conflict-of-interest statement: Mould DR is president of Projections Research Inc, which consults for pharmaceutical companies; Kutschera M has no conflicts of interest to declare; Primas C received lecture fees/consultant fees/advisory board member fees from AbbVie, MSD, Takeda, Janssen, Pfizer, Falk, Roche, Galapagos, Ferring, AstroPharma, and Amgen; Reinisch S received lecture fees/consultant fees/advisory board member fees from AbbVie, MSD, Takeda, Janssen, Pfizer, Gilead, Galapagos, Ferring, AstroPharma, BMS, Eli Lilly and Amgen; Novacek G received lecture fees/consultant fees/advisory board member fees from AbbVie, Merck Sharp and Dohme, Takeda, Janssen-Cilag, Pfizer, Gilead, Galapagos, Ferring, Vifor, AstroPharma, Falk, Bristol Myers Squibb, Arena Pharmaceuticals, and Amgen; Lichtenberger C has no interests to declare; Dervieux T is employee of Prometheus Laboratories; Bae Y is employee of Celltrion, Inc; Lee SH is employee of Celltrion, Inc. and has stock from Celltrion, Inc; Lee JH is employee of Celltrion, Inc. and has stock from Celltrion, Inc; Reinisch W has served as a speaker for AbbVie, Celltrion, Ferring, Galapagos, Janssen, MEDICE, MSD, Pfizer, Roche, Sobi, and Takeda; as a consultant for AbbVie, Amgen, AOP Orphan, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Galapagos, Gilead, Index Pharma, Janssen, MedAhead, Microbiotica, Pfizer, and Takeda; as an advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, Janssen, and Pfizer; and has received research funding from AbbVie, Janssen, Sandoz, Sanofi, and Takeda.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The data that support the findings of this study are available on request from the corresponding author and Celltrion, Inc. (Incheon, South Korea). The data are not publicly available due to privacy or ethical restrictions.
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/
Corresponding author: Diane R Mould, PhD, FCP, FAAPS, Projections Research Inc., 535 Springview Lane, Phoenixville, PA 19460, United States. drmould@pri-home.net
Received: August 28, 2025
Revised: September 18, 2025
Accepted: December 15, 2025
Published online: February 7, 2026
Processing time: 154 Days and 15.3 Hours
Revised: September 18, 2025
Accepted: December 15, 2025
Published online: February 7, 2026
Processing time: 154 Days and 15.3 Hours
Core Tip
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 the labeled dose were used to assess the 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 was small, the results are encouraging and suggest that further research on the use of clearance as a therapeutic endpoint is warranted in this area.