IOIBD technical review on endoscopic indices for Crohn's disease clinical trials.
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.



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.



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.
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.
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L
Vuitton
Department of Digestive Diseases, AP-HP, Hôpital Lariboisière and University Paris 7 Denis Diderot, Sorbonne Paris Cité, Paris, France.
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P
Marteau
Division of Gastroenterology, University of California-San Diego, La Jolla, California.
W J
WJ
Sandborn
Division of Gastroenterology, University of California-San Diego, La Jolla, California.
B G
BG
Levesque
Department of Medicine, Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada.
B
B
Feagan
Department of Gastroenterology, University of Leuven, University Hospitals Leuven, Leuven, Belgium.
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S
Vermeire
Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy.
S
S
Danese
Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
G
G
D'Haens
Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
M
M
Lowenberg
Department of Medicine, Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada.
R
R
Khanna
Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy.
G
G
Fiorino
Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK.
S
S
Travis
Biostatistics and Clinical Epidemiology, Inserm U717, Hôpital Saint-Louis, Paris, France.
J Y
JY
Mary
Department of Hepato-Gastroenterology, Inserm U954, University Hospital of Nancy-Brabois, Lorraine University, Vandoeuvre-lès-Nancy, France.
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Peyrin-Biroulet
D002986:Clinical Trials as Topic; D003424:Crohn Disease / Q000175:diagnosis / Q000628:therapy; D016099:Endoscopy, Gastrointestinal / Q000379:methods / Q000592:standards; D006801:Humans; D007413:Intestinal Mucosa / Q000000981:diagnostic imaging; D008991:Monitoring, Physiologic / Q000379:methods / Q000592:standards; D062072:Patient Acuity; D012074:Remission Induction; D012107:Research Design / Q000592:standards*; D012720:Severity of Illness Index
CROHN'S DISEASE