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
Research background

Ulcerative colitis (UC) represents a chronic inflammatory bowel disease with recurrent episodes of debilitating symptoms leading to an impaired health-related quality of life (HRQoL), especially in those patients with moderate-to severe UC. Besides HRQoL, in most of the patients, work productivity is negatively affected and an increased incapacity to work is reported due to UC. Therefore, UC causes additionally a substantial socioeconomic burden. Consequently, it is a considerable necessity to evaluate the impact of treatment options on work productivity and work life impairment. Golimumab, a human monoclonal tumor necrosis factor alpha (TNFα) antibody is indicated to treat moderate-to-severe UC in adult patients without effective response to conventional therapies and its use has led to significant decrease of symptom burden in treated subjects.

Research motivation

Until now, it is rarely evaluated how anti-TNFα therapy affected work life in patients with moderate-to-severe UC. In particular, there are no systematic data on the use of golimumab in patients with moderate-to-severe UC in Germany with regard to work life impairment, quality of life (QoL) and health economics.

Research objectives

The GO-CUTE study aimed to evaluate the changes in work productivity and HRQoL in UC patients treated with golimumab in Germany in order to assess the specific benefit of this treatment option. Changes in work productivity and the capacity for daily activities after three months represented the primary endpoint. The changes in HRQoL and disease specific QoL up to 1 year during golimumab treatment were defined as secondary endpoints.

Research methods

This non-interventional, observational, prospective study was conducted in fifty gas-troenterological practices in Germany. Work productivity and activity impairment were analyzed using the validated Work Productivity Activity Impairment (WPAI) Questionnaire. Short-form 12 health survey questionnaire (SF-12) and inflammatory bowel disease questionnaire (IBDQ) were used to complete HRQoL and disease-specific QoL assessment.

Research results

Our results showed a significant reduction in all WPAI sub-scores after the start of treatment with golimumab for each time point (month three, six, nine and twelve) when compared to baseline data (for each visit P < 0.0001, Wilcoxon signed rank test). A quarter of patients achieved a reduction of at least 25% in the absenteeism sub-score and a reduction of at least 40% in the presenteeism sub-score after three months of golimumab treatment. After twelve months, in 80% of the subjects the absenteeism sub-score and in 85% of the patients the presenteeism sub-score was enhanced. Significant improvements were also detected for disease-specific QoL as well as for HRQoL during treatment with golimumab (P < 0.0001 vs baseline, Wilcoxon signed rank test) assessed by IBDQ and SF-12, respectively.

Research conclusions

The results of the GO CUTE study demonstrated that golimumab treatment in patients suffering from moderate-to-severe UC significantly improves both patient´s work productivity and daily activity as well as HRQoL and disease-specific QoL. Furthermore, our data revealed that these benefits persisted over twelve months of treatment.

Research perspectives

We were able to show a strong responsiveness of the WPAI to the treatment of moderate-to severe UC with golimumab, but evidence from randomized controlled trials is additionally needed for final conclusions.