An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease

F. Rieder, D. Bettenworth, C. Ma, C. E. Parker, L. A. Williamson, S. A. Nelson, G. van Assche, A. Di Sabatino, Y. Bouhnik, R. W. Stidham, A. Dignass, G. Rogler, S. A. Taylor, J. Stoker, J. Rimola, M. E. Baker, Joel Garland Fletcher, J. Panes, W. J. Sandborn, B. G. FeaganV. Jairath

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Background: Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available; however, several therapies are currently under evaluation. Drug development for the indication of stricturing CD is hampered by a lack of standardised definitions, diagnostic modalities, clinical trial eligibility criteria, endpoints and treatment targets in stricturing CD. Aim: To standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Chron's disease. Methods: An interdisciplinary expert panel consisting of 15 gastroenterologists and radiologists was assembled. Using modified RAND/University of California Los Angeles appropriateness methodology, 109 candidate items derived from systematic review and expert opinion focusing on small intestinal strictures were anonymously rated as inappropriate, uncertain or appropriate. Survey results were discussed as a group before a second and third round of voting. Results: Fibrotic strictures are defined by the combination of luminal narrowing, wall thickening and pre-stenotic dilation. Definitions of anastomotic (at site of prior intestinal resection with anastomosis) and naïve small bowel strictures were similar; however, there was uncertainty regarding wall thickness in anastomotic strictures. Magnetic resonance imaging is considered the optimal technique to define fibrotic strictures and assess response to therapy. Symptomatic strictures are defined by abdominal distension, cramping, dietary restrictions, nausea, vomiting, abdominal pain and post-prandial abdominal pain. Need for intervention (endoscopic balloon dilation or surgery) within 24-48 weeks is considered the appropriate endpoint in pharmacological trials. Conclusions: Consensus criteria for diagnosis and response to therapy in stricturing Crohn's disease should inform both clinical practice and trial design.

Original languageEnglish (US)
Pages (from-to)347-357
Number of pages11
JournalAlimentary Pharmacology and Therapeutics
Volume48
Issue number3
DOIs
StatePublished - Aug 1 2018

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Crohn Disease
Pathologic Constriction
Therapeutics
Abdominal Pain
Dilatation
Clinical Trials
Los Angeles
Expert Testimony
Politics
Nausea
Uncertainty
Vomiting
Meals
Magnetic Resonance Imaging
Pharmacology
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

Cite this

An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease. / Rieder, F.; Bettenworth, D.; Ma, C.; Parker, C. E.; Williamson, L. A.; Nelson, S. A.; van Assche, G.; Di Sabatino, A.; Bouhnik, Y.; Stidham, R. W.; Dignass, A.; Rogler, G.; Taylor, S. A.; Stoker, J.; Rimola, J.; Baker, M. E.; Fletcher, Joel Garland; Panes, J.; Sandborn, W. J.; Feagan, B. G.; Jairath, V.

In: Alimentary Pharmacology and Therapeutics, Vol. 48, No. 3, 01.08.2018, p. 347-357.

Research output: Contribution to journalArticle

Rieder, F, Bettenworth, D, Ma, C, Parker, CE, Williamson, LA, Nelson, SA, van Assche, G, Di Sabatino, A, Bouhnik, Y, Stidham, RW, Dignass, A, Rogler, G, Taylor, SA, Stoker, J, Rimola, J, Baker, ME, Fletcher, JG, Panes, J, Sandborn, WJ, Feagan, BG & Jairath, V 2018, 'An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease', Alimentary Pharmacology and Therapeutics, vol. 48, no. 3, pp. 347-357. https://doi.org/10.1111/apt.14853
Rieder, F. ; Bettenworth, D. ; Ma, C. ; Parker, C. E. ; Williamson, L. A. ; Nelson, S. A. ; van Assche, G. ; Di Sabatino, A. ; Bouhnik, Y. ; Stidham, R. W. ; Dignass, A. ; Rogler, G. ; Taylor, S. A. ; Stoker, J. ; Rimola, J. ; Baker, M. E. ; Fletcher, Joel Garland ; Panes, J. ; Sandborn, W. J. ; Feagan, B. G. ; Jairath, V. / An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease. In: Alimentary Pharmacology and Therapeutics. 2018 ; Vol. 48, No. 3. pp. 347-357.
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abstract = "Background: Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available; however, several therapies are currently under evaluation. Drug development for the indication of stricturing CD is hampered by a lack of standardised definitions, diagnostic modalities, clinical trial eligibility criteria, endpoints and treatment targets in stricturing CD. Aim: To standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Chron's disease. Methods: An interdisciplinary expert panel consisting of 15 gastroenterologists and radiologists was assembled. Using modified RAND/University of California Los Angeles appropriateness methodology, 109 candidate items derived from systematic review and expert opinion focusing on small intestinal strictures were anonymously rated as inappropriate, uncertain or appropriate. Survey results were discussed as a group before a second and third round of voting. Results: Fibrotic strictures are defined by the combination of luminal narrowing, wall thickening and pre-stenotic dilation. Definitions of anastomotic (at site of prior intestinal resection with anastomosis) and na{\"i}ve small bowel strictures were similar; however, there was uncertainty regarding wall thickness in anastomotic strictures. Magnetic resonance imaging is considered the optimal technique to define fibrotic strictures and assess response to therapy. Symptomatic strictures are defined by abdominal distension, cramping, dietary restrictions, nausea, vomiting, abdominal pain and post-prandial abdominal pain. Need for intervention (endoscopic balloon dilation or surgery) within 24-48 weeks is considered the appropriate endpoint in pharmacological trials. Conclusions: Consensus criteria for diagnosis and response to therapy in stricturing Crohn's disease should inform both clinical practice and trial design.",
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T1 - An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease

AU - Rieder, F.

AU - Bettenworth, D.

AU - Ma, C.

AU - Parker, C. E.

AU - Williamson, L. A.

AU - Nelson, S. A.

AU - van Assche, G.

AU - Di Sabatino, A.

AU - Bouhnik, Y.

AU - Stidham, R. W.

AU - Dignass, A.

AU - Rogler, G.

AU - Taylor, S. A.

AU - Stoker, J.

AU - Rimola, J.

AU - Baker, M. E.

AU - Fletcher, Joel Garland

AU - Panes, J.

AU - Sandborn, W. J.

AU - Feagan, B. G.

AU - Jairath, V.

PY - 2018/8/1

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N2 - Background: Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available; however, several therapies are currently under evaluation. Drug development for the indication of stricturing CD is hampered by a lack of standardised definitions, diagnostic modalities, clinical trial eligibility criteria, endpoints and treatment targets in stricturing CD. Aim: To standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Chron's disease. Methods: An interdisciplinary expert panel consisting of 15 gastroenterologists and radiologists was assembled. Using modified RAND/University of California Los Angeles appropriateness methodology, 109 candidate items derived from systematic review and expert opinion focusing on small intestinal strictures were anonymously rated as inappropriate, uncertain or appropriate. Survey results were discussed as a group before a second and third round of voting. Results: Fibrotic strictures are defined by the combination of luminal narrowing, wall thickening and pre-stenotic dilation. Definitions of anastomotic (at site of prior intestinal resection with anastomosis) and naïve small bowel strictures were similar; however, there was uncertainty regarding wall thickness in anastomotic strictures. Magnetic resonance imaging is considered the optimal technique to define fibrotic strictures and assess response to therapy. Symptomatic strictures are defined by abdominal distension, cramping, dietary restrictions, nausea, vomiting, abdominal pain and post-prandial abdominal pain. Need for intervention (endoscopic balloon dilation or surgery) within 24-48 weeks is considered the appropriate endpoint in pharmacological trials. Conclusions: Consensus criteria for diagnosis and response to therapy in stricturing Crohn's disease should inform both clinical practice and trial design.

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