Defining Comprehensive Disease Control for Use as a Treatment Target for Ulcerative Colitis in Clinical Practice: International Delphi Consensus Recommendations

J Crohns Colitis. 2024 Jan 27;18(1):91-105. doi: 10.1093/ecco-jcc/jjad130.


Stefan Schreiber 1Silvio Danese 2Axel Dignass 3Eugeni Domènech 4 5Massimo C Fantini 6Marc Ferrante 7Jonas Halfvarson 8Ailsa Hart 9Fernando Magro 10Charlie W Lees 11Salvo Leone 12Marieke J Pierik 13Michele Peters 14Polly Field 15Helen Fishpool 15Laurent Peyrin-Biroulet 16 17 18 19 20 21


Author information

1University Hospital Schleswig-Holstein, Department of Internal Medicine I, Kiel, Germany.

2Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan, Italy.

3Department of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany.

4Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol and CIBEREHD, Badalona, Spain.

5Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.

6Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy.

7Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.

8Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.

9IBD Unit, St. Mark's Hospital, London, UK.

10CINTESIS@RISE, Faculty of Medicine of the University of Porto, Porto, Portugal.

11Edinburgh Inflammatory Bowel Disease Unit, Western General Hospital, Edinburgh, UK.

12European Federation of Crohn's & Ulcerative Colitis Associations [EFCCA], Brussels, Belgium.

13Division Gastroenterology and Hepatology, Maastricht University Medical Centre, Maastricht, The Netherlands.

14Nuffield Department of Population Health, University of Oxford, Oxford, UK.

15Oxford PharmaGenesis, Oxford, UK.

16Department of Gastroenterology, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

17Inserm, NGERE, University of Lorraine, Nancy, France.

18INFINY Institute, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

19FHU-CURE, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

20Groupe Hospitalier privé Ambroise Paré - Hartmann, Paris IBD Center, Neuilly sur Seine, France.

21Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, QC, Canada.


Background and aims: Treatment of ulcerative colitis [UC] requires a patient-centric definition of comprehensive disease control that considers improvements in aspects not typically captured by classical landmark trial endpoints. In an international initiative, we reviewed aspects of UC that affect patients and/or indicate mucosal inflammation, to achieve consensus on which aspects to combine in a definition of comprehensive disease control, using a modified Delphi process.

Methods: The Delphi panel comprised 12 gastroenterologists and one patient advocate. Two gastroenterologists were elected as chairs and did not vote. To inform statements, we asked 18 patients and the panel members about their experiences of remission and reviewed published literature. Panel members voted on statements anonymously in three rounds, with a live discussion before Round 3. Consensus was met if ≥67% of the panel agreed. Statements without consensus in Rounds 1 and 2 were revised or discarded after Round 3.

Results: The panel agreed to measure individual patient benefit using a definition of comprehensive disease control that combines aspects currently measured in trials [rectal bleeding, stool frequency, disease-related quality of life, endoscopy, histological inflammatory activity, inflammatory biomarkers, and corticosteroid use] with additional patient-reported symptoms [bowel urgency, abdominal pain, extraintestinal manifestations, fatigue, and sleep disturbance]. The panel agreed on scoring systems and thresholds for many aspects.

Conclusions: Using a robust methodology, we defined comprehensive disease control in UC. Next, we will combine the measurement and scoring of these aspects into a multicomponent tool and will adopt comprehensive disease control as a treatment target in clinical practice and trials.

© Copyright 2013-2024 GI Health Foundation. All rights reserved.
This site is maintained as an educational resource for US healthcare providers only. Use of this website is governed by the GIHF terms of use and privacy statement.