International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult Patients
Bénédicte Caron,
Vipul Jairath,
Ferdinando D’Amico,
Sameer Al Awadhi,
Axel Dignass,
Ailsa L. Hart,
Taku Kobayashi,
Paulo Gustavo Kotze,
Fernando Magro,
Britta Siegmund,
Kristine Paridaens,
Silvio Danese,
Laurent Peyrin-Biroulet
Affiliations
Bénédicte Caron
Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, France
Vipul Jairath
Department of Medicine, Western University, London, ON N6A 3K7, Canada
Ferdinando D’Amico
Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, 20132 Milan, Italy
Sameer Al Awadhi
Gastroenterology Division, Rashid Hospital, Dubai Health Authority, Dubai 003206, United Arab Emirates
Axel Dignass
Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, 60431 Frankfurt am Main, Germany
Ailsa L. Hart
Inflammatory Bowel Disease Unit, St. Mark’s Hospital, Harrow HA1 3UJ, UK
Taku Kobayashi
Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo 108-8642, Japan
Paulo Gustavo Kotze
IBD Outpatient Clinics, Colorectal Surgery Unit, Pontificia Universidade Católica do Paraná (PUCPR), Curitiba 80215-901, Brazil
Fernando Magro
Unit of Pharmacology and Therapeutics, Department of Biomedicine, Faculty of Medicine, University of Porto, 4200319 Porto, Portugal
Britta Siegmund
Charité–Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, 10117 Berlin, Germany
Kristine Paridaens
Ferring International Center S.A. Ch. De la Vergognausaz 50, 1162 Saint-Prex, Switzerland
Silvio Danese
Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, 20132 Milan, Italy
Laurent Peyrin-Biroulet
Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, France
Background and Objectives: At present, there is no consensus definition of mild-to-moderate disease activity in patients with ulcerative colitis. The objective of the present study was to establish a reliable definition of mild-to-moderate disease activity in adult patients with ulcerative colitis. Materials and Methods: Twelve physicians from around the world participated in a virtual consensus meeting on 26 September 2022. All the physicians had expertise in the diagnosis and treatment of inflammatory bowel disease. After a systematic review of the literature and expert opinion, a modified version of the RAND/University of California, Los Angeles appropriateness method was applied. A total of 49 statements were identified and then anonymously rated (on a 9-point scale) as being appropriate (scores of 7 to 9), uncertain (4 to 6) or inappropriate (1 to 3). The survey results were reviewed and amended before a second round of voting. Results: Symptom and endoscopic-based measurements are of prime importance for assessing mild-to-moderate ulcerative colitis activity in clinical trials. The experts considered that clinical activity should be assessed in terms of stool frequency, rectal bleeding and fecal urgency, whereas endoscopic activity should be evaluated with regard to the vascular pattern, bleeding, erosions and ulcers. Fecal calprotectin was considered to be a suitable disease activity marker in mild-to-moderate ulcerative colitis. Lastly, mild-to-moderate ulcerative colitis should not have more than a small impact on the patient’s daily activities. Conclusions: The present recommendations constitute a standardized framework for defining mild-to-moderate disease activity in clinical trials in the field of ulcerative colitis.
