International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult Patients

<i>Background and Objectives</i>: 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 u...

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Main Authors: 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
Format: Article
Language:English
Published: MDPI AG 2023-01-01
Series:Medicina
Subjects:
Online Access:https://www.mdpi.com/1648-9144/59/1/183
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author 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
author_facet 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
author_sort Bénédicte Caron
collection DOAJ
description <i>Background and Objectives</i>: 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. <i>Materials and Methods</i>: 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. <i>Results</i>: 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. <i>Conclusions</i>: The present recommendations constitute a standardized framework for defining mild-to-moderate disease activity in clinical trials in the field of ulcerative colitis.
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spelling doaj.art-7084dc964d414d2a925b15b511cafcce2023-11-30T23:25:38ZengMDPI AGMedicina1010-660X1648-91442023-01-0159118310.3390/medicina59010183International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult PatientsBénédicte Caron0Vipul Jairath1Ferdinando D’Amico2Sameer Al Awadhi3Axel Dignass4Ailsa L. Hart5Taku Kobayashi6Paulo Gustavo Kotze7Fernando Magro8Britta Siegmund9Kristine Paridaens10Silvio Danese11Laurent Peyrin-Biroulet12Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, FranceDepartment of Medicine, Western University, London, ON N6A 3K7, CanadaGastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, 20132 Milan, ItalyGastroenterology Division, Rashid Hospital, Dubai Health Authority, Dubai 003206, United Arab EmiratesDepartment of Medicine I, Agaplesion Markus Hospital, Goethe-University, 60431 Frankfurt am Main, GermanyInflammatory Bowel Disease Unit, St. Mark’s Hospital, Harrow HA1 3UJ, UKCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo 108-8642, JapanIBD Outpatient Clinics, Colorectal Surgery Unit, Pontificia Universidade Católica do Paraná (PUCPR), Curitiba 80215-901, BrazilUnit of Pharmacology and Therapeutics, Department of Biomedicine, Faculty of Medicine, University of Porto, 4200319 Porto, PortugalCharité–Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, 10117 Berlin, GermanyFerring International Center S.A. Ch. De la Vergognausaz 50, 1162 Saint-Prex, SwitzerlandGastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, 20132 Milan, ItalyDepartment of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, France<i>Background and Objectives</i>: 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. <i>Materials and Methods</i>: 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. <i>Results</i>: 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. <i>Conclusions</i>: The present recommendations constitute a standardized framework for defining mild-to-moderate disease activity in clinical trials in the field of ulcerative colitis.https://www.mdpi.com/1648-9144/59/1/183ulcerative colitismildmoderatedefinitionactivity
spellingShingle 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
International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult Patients
Medicina
ulcerative colitis
mild
moderate
definition
activity
title International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult Patients
title_full International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult Patients
title_fullStr International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult Patients
title_full_unstemmed International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult Patients
title_short International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult Patients
title_sort international consensus on definition of mild to moderate ulcerative colitis disease activity in adult patients
topic ulcerative colitis
mild
moderate
definition
activity
url https://www.mdpi.com/1648-9144/59/1/183
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