Kruis W, Jessen P, Morgenstern J, Reimers B, Müller-Grage N, Bokemeyer B. Shared decision-making improves adherence to mesalamine in ulcerative colitis: A prospective, multicenter, non-interventional cohort study in Germany. World J Gastroenterol 2025; 31(22): 101915 [DOI: 10.3748/wjg.v31.i22.101915]
Corresponding Author of This Article
Wolfgang Kruis, MD, PhD, Full Professor, Department of Internal Medicine and Gastroenterology, Protestant Hospital Cologne-Kalk, Teaching Hospital of the University of Cologne, Buchforststr 2, Cologne 51103, Germany. wolfgang.kruis@googlemail.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Prospective Study
Open-Access Policy of This Article
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/
World J Gastroenterol. Jun 14, 2025; 31(22): 101915 Published online Jun 14, 2025. doi: 10.3748/wjg.v31.i22.101915
Shared decision-making improves adherence to mesalamine in ulcerative colitis: A prospective, multicenter, non-interventional cohort study in Germany
Wolfgang Kruis, Petra Jessen, Julia Morgenstern, Birgitta Reimers, Nike Müller-Grage, Bernd Bokemeyer
Wolfgang Kruis, Julia Morgenstern, Department of Internal Medicine and Gastroenterology, Protestant Hospital Cologne-Kalk, Teaching Hospital of the University of Cologne, Cologne 51103, Germany
Wolfgang Kruis, Faculty of Medicine, University of Cologne, Cologne 50931, Germany
Petra Jessen, Gastroenterology Practice, Kiel-Altenholz 24161, Germany
Birgitta Reimers, Nike Müller-Grage, Department of Medical, Ferring Arzneimittel GmbH, Kiel 24103, Germany
Bernd Bokemeyer, Interdisciplinary Crohn Colitis Center, Minden 32423, Germany
Bernd Bokemeyer, Department of General Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel 24105, Germany
Co-first authors: Wolfgang Kruis and Bernd Bokemeyer.
Author contributions: Kruis W and Bokemeyer B contributed equally to the conception and design of the study; Kruis W led the overall coordination of the project, and together with Bokemeyer B, was responsible for drafting the manuscript; Jessen P and Morgenstern J contributed to data acquisition and analysis; Reimers B and Müller-Grage N provided support in ensuring adherence to the study protocol and in data analysis; All authors critically reviewed the manuscript, provided significant intellectual input, contributed to its various drafts, and approved the final version for submission.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of the North Rhine Chamber of Physicians (Approval No. 2011343).
Clinical trial registration statement: The study was registered on ClinicalTrials.gov (NCT01517607).
Informed consent statement: All study participants provided signed informed consent before study enrollment.
Conflict-of-interest statement: The authors no conflicts of interest to declare.
Data sharing statement: The data upon which the findings of this study are based are available from the corresponding author upon reasonable request at wolfgang.kruis@googlemail.com.
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: Wolfgang Kruis, MD, PhD, Full Professor, Department of Internal Medicine and Gastroenterology, Protestant Hospital Cologne-Kalk, Teaching Hospital of the University of Cologne, Buchforststr 2, Cologne 51103, Germany. wolfgang.kruis@googlemail.com
Received: October 9, 2024 Revised: April 25, 2025 Accepted: May 26, 2025 Published online: June 14, 2025 Processing time: 245 Days and 18 Hours
Abstract
BACKGROUND
Mesalamine is the recommended first-line treatment for inducing and maintaining remission in mild-to-moderate ulcerative colitis (UC). However, adherence in real-world settings is frequently suboptimal. Encouraging collaborative patient-provider relationships may foster better adherence and patient outcomes.
AIM
To quantify the association between patient participation in treatment decision-making and adherence to oral mesalamine in UC.
METHODS
We conducted a 12-month, prospective, non-interventional cohort study at 113 gastroenterology practices in Germany. Eligible patients were aged ≥ 18 years, had a confirmed UC diagnosis, had no prior mesalamine treatment, and provided informed consent. At the first visit, we collected data on demographics, clinical characteristics, patient preference for mesalamine formulation (tablets or granules), and disease knowledge. Self-reported adherence and disease activity were assessed at all visits. Correlation analyses and logistic regression were used to examine associations between adherence and various factors.
RESULTS
Of the 605 consecutively screened patients, 520 were included in the study. The median age was 41 years (range: 18-91), with a male-to-female ratio of 1.1:1.0. Approximately 75% of patients reported good adherence at each study visit. In correlation analyses, patient participation in treatment decision-making was significantly associated with better adherence across all visits (P = 0.04). In the regression analysis at 12 months, this association was evident among patients who both preferred and received prolonged-release mesalamine granules (odds ratio = 2.73, P = 0.001). Patients reporting good adherence also experienced significant improvements in disease activity over 12 months (P < 0.001).
CONCLUSION
Facilitating patient participation in treatment decisions and accommodating medication preferences may improve adherence to mesalamine. This may require additional effort but has the potential to improve long-term management of UC.
Core Tip: In this 12-month prospective study, we found that when patients were actively involved in choosing their mesalamine formulation, such as tablets versus granules, their adherence to therapy significantly improved. This was especially true when patients both preferred and received mesalamine granules. Importantly, patients who reported good adherence also experienced better outcomes, with significant improvements in disease activity over the course of the study. Our findings suggest that supporting shared decision-making in routine care and accommodating patient preferences, particularly regarding medication formulation, can make a difference in long-term management of ulcerative colitis.
