L Vuitton1, P Marteau2, W J Sandborn3, B G Levesque3, B Feagan4, S Vermeire5, S Danese6, G D'Haens7, M Lowenberg7, R Khanna4, G Fiorino6, S Travis8, J Y Mary9, L Peyrin-Biroulet10. 1. Department of Gastroenterology and Endoscopy Unit, Besançon University Hospital, Besançon, France Department of Hepato-Gastroenterology, Inserm U954, University Hospital of Nancy-Brabois, Lorraine University, Vandoeuvre-lès-Nancy, France. 2. Department of Digestive Diseases, AP-HP, Hôpital Lariboisière and University Paris 7 Denis Diderot, Sorbonne Paris Cité, Paris, France. 3. Division of Gastroenterology, University of California-San Diego, La Jolla, California. 4. Department of Medicine, Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada. 5. Department of Gastroenterology, University of Leuven, University Hospitals Leuven, Leuven, Belgium. 6. Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy. 7. Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands. 8. Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK. 9. Biostatistics and Clinical Epidemiology, Inserm U717, Hôpital Saint-Louis, Paris, France. 10. Department of Hepato-Gastroenterology, Inserm U954, University Hospital of Nancy-Brabois, Lorraine University, Vandoeuvre-lès-Nancy, France.
Abstract
BACKGROUND: Crohn's disease (CD) is a chronic disabling and progressive IBD. Only strategies looking beyond symptoms and based on tight monitoring of objective signs of inflammation such as mucosal lesions may have the potential for disease modification. Endoscopic evaluation is currently the gold standard to assess mucosal lesions and has become a major therapeutic endpoint in clinical trials. Several endoscopic indices have been proposed to evaluate disease activity; unvalidated and arbitrary definitions have been used in clinical trials for defining endoscopic response and endoscopic remission in CD. METHODS: In these recommendations from the International Organization for the Study of Inflammatory Bowel Disease, we first reviewed all technical aspects of available endoscopic scoring systems in the literature. Second, in order to achieve consensus on endoscopic definitions of remission and response in trials, a two-round vote based on a Delphi method was performed among 14 specialists in the field of IBDs. RESULTS: At the end of the voting process, the investigators ranked first a >50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) or Crohn's Disease Endoscopic Index of Severity for the definition of endoscopic response, and an SES-CD 0-2 for the definition of endoscopic remission in CD. All experts agreed on a Rutgeerts' score i0-i1 for the definition of endoscopic remission after surgery. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
BACKGROUND:Crohn's disease (CD) is a chronic disabling and progressive IBD. Only strategies looking beyond symptoms and based on tight monitoring of objective signs of inflammation such as mucosal lesions may have the potential for disease modification. Endoscopic evaluation is currently the gold standard to assess mucosal lesions and has become a major therapeutic endpoint in clinical trials. Several endoscopic indices have been proposed to evaluate disease activity; unvalidated and arbitrary definitions have been used in clinical trials for defining endoscopic response and endoscopic remission in CD. METHODS: In these recommendations from the International Organization for the Study of Inflammatory Bowel Disease, we first reviewed all technical aspects of available endoscopic scoring systems in the literature. Second, in order to achieve consensus on endoscopic definitions of remission and response in trials, a two-round vote based on a Delphi method was performed among 14 specialists in the field of IBDs. RESULTS: At the end of the voting process, the investigators ranked first a >50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) or Crohn's Disease Endoscopic Index of Severity for the definition of endoscopic response, and an SES-CD 0-2 for the definition of endoscopic remission in CD. All experts agreed on a Rutgeerts' score i0-i1 for the definition of endoscopic remission after surgery. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Authors: Robert P Hirten; Ryan C Ungaro; Daniel Castaneda; Sarah Lopatin; Bruce E Sands; Jean Frederic Colombel; Benjamin L Cohen Journal: Inflamm Bowel Dis Date: 2020-06-18 Impact factor: 5.325
Authors: Kelly C Cushing; Richard Mclean; Keely G McDonald; Jenny K Gustafsson; Kathryn A Knoop; Devesha H Kulkarni; R Balfour Sartor; Rodney D Newberry Journal: Inflamm Bowel Dis Date: 2019-01-01 Impact factor: 5.325