Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 7, 2020; 26(21): 2852-2863
Published online Jun 7, 2020. doi: 10.3748/wjg.v26.i21.2852
Golimumab in real-world practice in patients with ulcerative colitis: Twelve-month results
Niels Teich, Harald Grümmer, Eric Jörgensen, Thomas Liceni, Frank Holtkamp-Endemann, Tim Fischer, Susanne Hohenberger
Niels Teich, Internistische Gemeinschaftspraxis für Verdauungs-und Stoffwechselkrankheiten Leipzig und Schkeuditz, Leipzig 04105, Germany
Harald Grümmer, Praxis für Innere Medizin/Gastroenterologie, Potsdam 14471, Germany
Eric Jörgensen, Magen-Darm-Zentrum Remscheid, Remscheid 42859, Germany
Thomas Liceni, MVZ für Gastroenterologie am Bayerischen Platz, Berlin 10825, Germany
Frank Holtkamp-Endemann, Gastroenterologische Gemeinschaftspraxis am Germania-Campus, Münster 48159, Germany
Tim Fischer, Susanne Hohenberger, Medical Affairs, MSD Sharp and Dohme GmbH, Haar 85540, Germany
Author contributions: Hohenberger S contributed to study conception and study design; Teich N, Grümmer H, Jörgensen H, Liceni T and Holtkamp-Endemann F participated in the acquisition, analysis, and interpretation of the data, and drafted the initial manuscript; Hohenberger S and Fischer T reviewed the manuscript; all authors read and approved the final version of the manuscript.
Supported by MSD Sharp and Dohme GmbH, Haar, Germany.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board Ethics Committee of the Bavarian State Medical Association (Bayrische Landesärztekammer), Munich, Germany.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Niels Teich has served as a speaker, a consultant and/or an advisory board member for AbbVie, Biogen, Falk Foundation, Janssen, MSD, Norgine, Takeda, Tillotts, Vifor and has received research funding from Ferring Arzneimittel GmbH; Harald Grümmer has received personal fees from MSD and AbbVie; Eric Jörgensen has received personal fees from MSD, Thomas Liceni has received personal fees from MSD, Frank Holtkamp-Endemann has received personal fees from MSD, Tim Fischer and Susanne Hohenberger are employees of MSD.
STROBE statement: The authors have read the STROBE statement-checklist of items, and the manuscript was prepared and revised according to the STROBE statement-checklist of items.
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: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Niels Teich, MD, Internistische Gemeinschaftspraxis für Verdauungs-und Stoffwechselkrankheiten Leipzig und Schkeuditz, Nordstr. 21, Leipzig 04105, Germany. teich@igvs.de
Received: February 6, 2020
Peer-review started: February 6, 2020
First decision: March 21, 2020
Revised: May 8, 2020
Accepted: May 23, 2020
Article in press: May 23, 2020
Published online: June 7, 2020
Processing time: 121 Days and 4.8 Hours
Core Tip

Core tip: Systematic reviews indicate that ulcerative colitis (UC) causes a significant socioeconomic burden, but prospective studies are scarce. The aim of this study is to evaluate the changes in work productivity and quality of life (QoL) of UC patients in Germany treated with the human monoclonal tumor necrosis factor alpha antibody golimumab in order to assess the specific benefit of this treatment option. This prospective non-interventional study included 287 patients. Based on these data we were able to show that treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient´s work productivity, daily activity and QoL over twelve months.