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Original article
IOIBD technical review on endoscopic indices for Crohn's disease clinical trials
  1. L Vuitton1,2,
  2. P Marteau3,
  3. W J Sandborn4,
  4. B G Levesque4,
  5. B Feagan5,
  6. S Vermeire6,
  7. S Danese7,
  8. G D'Haens8,
  9. M Lowenberg8,
  10. R Khanna5,
  11. G Fiorino7,
  12. S Travis9,
  13. J Y Mary10,
  14. L Peyrin-Biroulet2
  1. 1Department of Gastroenterology and Endoscopy Unit, Besançon University Hospital, Besançon, France
  2. 2Department of Hepato-Gastroenterology, Inserm U954, University Hospital of Nancy-Brabois, Lorraine University, Vandoeuvre-lès-Nancy, France
  3. 3Department of Digestive Diseases, AP-HP, Hôpital Lariboisière and University Paris 7 Denis Diderot, Sorbonne Paris Cité, Paris, France
  4. 4Division of Gastroenterology, University of California-San Diego, La Jolla, California
  5. 5Department of Medicine, Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada
  6. 6Department of Gastroenterology, University of Leuven, University Hospitals Leuven, Leuven, Belgium
  7. 7Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy
  8. 8Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands
  9. 9Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK
  10. 10Biostatistics and Clinical Epidemiology, Inserm U717, Hôpital Saint-Louis, Paris, France
  1. Correspondence to Dr Laurent Peyrin-Biroulet, Inserm U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy-Brabois, Lorraine University, 1 Allée du Morvan, Vandoeuvre-lès-Nancy F54511, France; peyrinbiroulet{at}gmail.com

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.

  • CROHN'S DISEASE

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