Prospective Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 28, 2017; 23(8): 1489-1496
Published online Feb 28, 2017. doi: 10.3748/wjg.v23.i8.1489
Clinical correlations of infliximab trough levels and antibodies to infliximab in South Korean patients with Crohn’s disease
Eun Hye Oh, Dae-Hyun Ko, Hyungil Seo, Kiju Chang, Gwang-Un Kim, Eun Mi Song, Myeongsook Seo, Ho-Su Lee, Sung Wook Hwang, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Sang Hyoung Park
Eun Hye Oh, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, South Korea
Dae-Hyun Ko, Department of Laboratory Medicine, Hallym University College of Medicine, Dongtan Sacred Heart Hospital, Hwaseong 18450, South Korea
Hyungil Seo, Kiju Chang, Gwang-Un Kim, Eun Mi Song, Myeongsook Seo, Sung Wook Hwang, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Sang Hyoung Park, Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, South Korea
Ho-Su Lee, Health Screening and Promotion Center, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, South Korea
Author contributions: Oh EH drafted the manuscript, and analyzed data; Ko DH carried out laboratory tests checking infliximab trough levels and antibodies to infliximab using sera of the study patients; Seo H, Chang K, Kim GU, Song EM, Seo M, Lee HS, Hwang SW, Yang DH, Ye BD, Byeon JS, Myung SJ and Yang SK were involved with the study patients enrollment, data collection and data analysis; Park SH designed the study and analyzed data; all authors read and approved the final manuscript. Oh EH and Ko DH contributed equally to this article.
Supported by the Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea, No. 2015-637.
Institutional review board statement: The study was reviewed and approved by the institutional review boards of Asan Medical Center (Seoul, South Korea; IRB No. 2015-0173).
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: All the authors have no conflict of interest related to the manuscript.
Data sharing statement: There is no additional data available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Sang Hyoung Park, MD, PhD, Assistant Professor, Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, South Korea. umdalpin@hanmail.net
Telephone: +82-2-30105768 Fax: +82-2-4760824
Received: September 23, 2016
Peer-review started: September 26, 2016
First decision: December 2, 2016
Revised: December 15, 2016
Accepted: January 17, 2017
Article in press: January 17, 2017
Published online: February 28, 2017
Abstract
AIM

To investigate the clinical implications of infliximab trough levels (IFX-TLs) and antibodies to infliximab (ATI) levels in Crohn’s disease (CD) patients in Asian countries.

METHODS

IFX-TL and ATI level were measured using prospectively collected samples obtained with informed consent from CD patients being treated at Asan Medical Center, South Korea. We analyzed the correlations between IFX-TLs/ATI levels and the clinical activity of CD (quiescent vs active disease) based on the CD activity index, C-reactive protein level, and physician’s judgment of patients’ clinical status at enrollment. The impact of concomitant immunomodulators was also investigated.

RESULTS

This study enrolled 138 patients with CD (84 with quiescent and 54 with active disease). In patients with quiescent and active diseases, the median IFX-TLs were 1.423 μg/mL and 0.163 μg/mL, respectively (P < 0.001) and the median ATI levels were 8.064 AU/mL and 11.209 AU/mL, respectively (P < 0.001). In the ATI-negative and -positive groups, the median IFX-TLs were 1.415 μg/mL and 0.141 μg/mL, respectively (P < 0.001). In patients with and without concomitant immunomodulator use, there were no differences in IFX-TLs (0.632 μg/mL and 1.150 μg/mL, respectively; P = 0.274) or ATI levels (8.655 AU/mL and 9.017 AU/mL, respectively; P = 0.083).

CONCLUSION

IFX-TL/ATI levels were well correlated with the clinical activity in South Korean CD patients. Our findings support the usefulness of IFX-TLs/ATI levels in treating CD patients receiving IFX in clinical practice.

Keywords: Infliximab, Drug effect, Antibody, Crohn’s disease, Drug monitoring

Core tip: This study aimed to clarify the clinical implications of infliximab trough levels (IFX-TLs) and antibodies to infliximab (ATI) levels. They were measured using prospectively collected samples in 138 Crohn’s disease (CD) patients being treated at Asan Medical Center, South Korea. Correlations between IFX-TLs/ATIs and the clinical activity (P < 0.001) were verified in the study. Our findings support the usefulness of IFX-TLs/ATI levels in treating CD patients receiving IFX in clinical practices.