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. 2023 Jan 16;59(1):183.
doi: 10.3390/medicina59010183.

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

Bénédicte Caron  1 , Vipul Jairath  2   3 , Ferdinando D'Amico  4   5 , Sameer Al Awadhi  6 , Axel Dignass  7 , Ailsa L Hart  8 , Taku Kobayashi  9 , Paulo Gustavo Kotze  10 , Fernando Magro  11   12   13 , Britta Siegmund  14   15 , Kristine Paridaens  16 , Silvio Danese  4 , Laurent Peyrin-Biroulet  1
Affiliations

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

Bénédicte Caron et al. Medicina (Kaunas). .

Abstract

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.

Keywords: activity; definition; mild; moderate; ulcerative colitis.

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Conflict of interest statement

B.C. reports lecture and/or consulting fees from Abbvie, Amgen, Celltrion, Ferring, Galapagos, Janssen, Takeda. V.J. reports consulting/advisory board fees from AbbVie, Alimentiv Inc (formerly Robarts Clinical Trials), Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Reistone Biopharma, Roche, Sandoz, Second Genome, Takeda, Teva, Topivert, Vividion; speaker’s fees from, Abbvie, Ferring, Galapagos, Janssen Pfizer Shire, Takeda, Fresenius Kabi. F D’Amico has served as a speaker for Janssen, Galapagos, Sandoz, and Omega Pharma. S Al Awadhi reports no conflict of interest. A Dignass received fees for participation in clinical trials and review activities (ie, data monitoring boards, statistical analysis, and end point committees) from AbbVie, Celgene/Bristol Myers Squibb, Falk Foundation, Gilead, Janssen, and Pfizer; received consultancy fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene/Bristol Myers Squibb, Eli Lilly, Falk, Ferring, Fresenius Kabi, Galapagos, Gilead, Janssen, MSD, Pfizer, Pharmacosmos, Roche/Genentech, Sandoz/Hexal, Takeda, Tillotts, and Vifor; and received payment for lectures, including service on speaker bureaus, from AbbVie, Eli Lilly, Falk Foundation, Ferring, Gilead/Galapagos, Janssen, MSD, Pfizer, Takeda, Tillotts, and Vifor; received payment for development of educational presentations from Ferring and Tillotts. A L Hart has served as a speaker, consultant, and advisory board member for AbbVie, AstraZeneca, BMS, Celltrion, Ferring, Galapagos, Genentech, Janssen, Johnson and Johnson, Takeda, MSD, Pfizer, Roche, Pharmacosmos. T Kobayashi has served as a speaker, a consultant or an advisory board member for AbbVie, Activaid, Astellas, Alfresa Pharma, Bristol Myers Squibb, Celltrion, Covidien, EA Pharma, Eli Lilly, Ferring Pharmaceuticals, Gilead Sciences, Janssen, JIMRO, JMDC, Kissei, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Thermo Scientific and Zeria Pharmaceutical, and has received research funding from AbbVie, Alfresa Pharma, EA Pharma, Kyorin Pharmaceutical, Mochida Pharmaceutical, Nippon Kayaku, Otsuka Holdings, Sekisui Medical, Thermo Fisher Scientific and Zeria Pharmaceutical. P G Kotze has served as a speaker and consultant for Abbvie, Janssen, Pfizer and Takeda. He also received scientific grants from Pfizer and Takeda. F Magro severd as speaker for: Abbvie, Arena, Biogen, Bristol-Myers Squibb, Falk, Ferring, Hospira, Janssen, Laboratórios Vitoria, Pfizer, Lilly, Merck Sharp & Dohme, Sandoz, Takeda, UCB, Vifor. B Siegmund has served as consultant for Abbvie, Arena, BMS, Boehringer, Celgene, Falk, Galapagos, Janssen, Lilly, Pfizer, PredictImmune and Takeda and received speaker’s fees from Abbvie, BMS, CED Service GmbH, Falk, Ferring, Janssen, Novartis, Pfizer, Takeda, grants from Pfizer [served as representative of the Charité]. K Paridaens is an employee of Ferring Pharmaceuticals. S Danese has served as a speaker, consultant, and advisory board member for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma and Vifor. L Peyrin-Biroulet reports personal fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Celltrion, Takeda, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Inotrem, Allergan, MSD, Roche, Arena, Gilead, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, OSE Immunotherapeutics, Enthera, Theravance, Pandion Therapeutics, Gossamer Bio, Viatris, Thermo Fisher; grants from Abbvie, MSD, Takeda, Fresenius Kabi; stock options: CTMA.

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