Systematic Reviews
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Meta-Anal. Aug 26, 2017; 5(4): 85-102
Published online Aug 26, 2017. doi: 10.13105/wjma.v5.i4.85
Remission endpoints in ulcerative colitis: A systematic review
Maki Jitsumura, Rory Frederick Kokelaar, Dean Anthony Harris
Maki Jitsumura, Rory Frederick Kokelaar, Dean Anthony Harris, Colorectal Department, Singleton Hospital, Abertawe Bro Morgannwg, University Health Board, Swansea SA2 8QA, United Kingdom
Author contributions: Jitsumura M and Harris DA conceptualised and designed the study; Jitsumura M and Kokelaar RF conducted the systematic review of the literature; Jitsumura M performed data analysis; Jitsumura M, Kokelaar RF and Harris DA contributed to the drafting and revision of the manuscript; all authors have read and approved the final manuscript.
Conflict-of-interest statement: There is no financial conflict of interest to declare for any of the authors.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at dean.a.harris@wales.nhs.uk. No additional data are 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: Dean Anthony Harris, MD, FRCS, MB ChB, Honorary Clinical Professor, Colorectal Department, Singleton Hospital, Abertawe Bro Morgannwg, University Health Board, Sketty Lane, Swansea SA2 8QA, United Kingdom. dean.a.harris@wales.nhs.uk
Telephone: +44-0179-2285459
Received: January 27, 2017
Peer-review started: February 12, 2017
First decision: March 8, 2017
Revised: May 3, 2017
Accepted: May 12, 2017
Article in press: May 15, 2017
Published online: August 26, 2017
Abstract
AIM

To summarize the current consensus on the definition of remission and the endpoints employed in clinical trials.

METHODS

A bibliogragraphic search was performed from 1946 to 2016 sing online databases (National Library of Medicine’s PubMed Central Medline, OVID SP MEDLINE, OVID EMBASE, the Cochrane Library and Conference Abstracts) with key words: (“ulcerative colitis”) AND (“ulcerative colitis endoscopic index of severity” OR “UCEIS”) AND (“remission”) as well as (“ulcerative colitis”) AND (“ulcerative colitis disease activity index”) OR “UCDAI” OR “UC disease activity index” OR “Sutherland index”) AND (“remission”).

RESULTS

The search returned 37 and 116 articles for the UCEIS and UCDAI respectively. For the UCEIS, 12 articles were cited in the final analysis of which 9 validation studies have been identified. Despite the UCEIS has been more extensively validated in all three aspects (validity, responsiveness and reliability), it has been little employed to monitor disease in randomised clinical trials. For the UCDAI, 37 articles were considered for the final analysis. Although the UCDAI is only partially validated, 29 randomised clinical trials were acknowledged to use the UCDAI to determine endpoints and disease remission, though no clear protocol was identified.

CONCLUSION

Although the UCEIS has been more widely validated than the UCDAI, it has not been reflected in the monitoring of disease activity in clinical trials. Conversely, the UCDAI has been used in numerous large clinical trials to define their endpoints and disease remission, however, it is challenging to determine the best possible outcomes due to a lack of homogeneity of the clinical trial protocols. Before determining a gold standard index, international agreement on remission is urgently needed to advance patient care.

Keywords: Ulcerative colitis, Remission, Ulcerative colitis endoscopic index of severity, Ulcerative disease activity index

Core tip: Despite the decades of discussion, disease remission for ulcerative colitis has yet to be fully defined. Instead, numerous indices that measure a large variety of endpoints had been developed, each claiming to be accurate and informative. This systematic review aimed to summarise the issues related to the uncertain definition of disease remissions in clinical trial studies by focusing on two indices ulcerative colitis endoscopic index of severity and ulcerative disease activity index. We recommend that an international consensus of remission should be sought before establishing a gold standard outcome measurement to untangle this confusion.