Journal
INFLAMMATORY BOWEL DISEASES
Volume 20, Issue 10, Pages 1850-1861Publisher
OXFORD UNIV PRESS INC
DOI: 10.1097/MIB.0000000000000131
Keywords
Crohn's disease; Crohn's disease endoscopic index of severity; endoscopic indices; mucosal healing; outcome measures; simple endoscopic score for Crohn's disease; systematic review
Categories
Funding
- Abbott Laboratories
- Ferring
- MSD Pharma
- Abbott
- ActoGeniX NV
- AGI Therapeutics Inc
- Alba Therapeutics Corp
- Albireo
- Alfa Wasserman
- Amgen
- AM-Pharma BV
- Anaphore
- Astellas
- Athersys Inc
- Atlantic Healthcare Ltd
- Aptalis
- BioBalance Corp
- Boehringer-Ingelheim
- Bristol-Myers Squibb
- Celgene
- Celek Pharmaceuticals
- Cellerix SL
- Cerimon Pharmaceuticals
- ChemoCentryx
- CoMentis
- Cosmo Technologies
- Coronado Biosciences
- Cytokine Pharmasciences
- Eagle Pharmaceuticals
- EnGene Inc
- Eli Lilly
- Enteromedics
- Exagen Diagnostics Inc
- Ferring Pharmaceuticals
- Flexion Therapeutics Inc
- Funxional Therapeutics Ltd
- Genzyme Corp
- Gilead Sciences
- Given Imaging
- GlaxoSmithKline
- Human Genome Sciences
- Ironwood Pharmaceuticals
- Janssen Pharmaceutical Research & Development, LLC
- KaloBios Pharmaceuticals
- Lexicon Pharmaceuticals
- Lycera Corp
- Medea Pharmaceuticals
- Merck Research Laboratories
- Merck Serono
- Millenium Pharmaceuticals
- Nisshin Kyorin Pharmaceuticals
- Novo Nordisk
- NPS Pharmaceuticals
- Optimer Pharmaceuticals
- Orexigen Therapeutics Inc
- PDL Biopharma
- Pfizer
- Procter and Gamble
- Prometheus Laboratories
- ProtAb Ltd
- Purgenesis Technologies Inc
- Relypsa Inc
- Roche
- Salient Pharmaceuticals
- Salix Pharmaceuticals
- Santarus
- Schering Plough
- Shire Pharmaceuticals
- Sigmoid Pharma Ltd
- Sirtris Pharmaceuticals
- SLA Pharma UK Ltd
- Targacept
- Teva Pharmaceuticals
- Therakos
- Tilliotts Pharma AG
- TxCell SA
- UCB Pharma
- Viamet Pharmaceuticals
- Vascular Biogenics Ltd
- Warner Chilcott UK Ltd
- Wyeth
- Genentech
- Milennium Pharmaceuticals
- Novartis
- Abbott/AbbVie
- Astra Zeneca
- Bristol-Myers Squibb (BMS)
- Janssen Biotech (Centocor)
- JnJ/Janssen, Roche/Genentech
- Millennium
- Receptos
- Sanofi
- Tillotts
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Background: Crohn's disease (CD) is a chronic idiopathic inflammatory disorder of the gastrointestinal tract. Recently, mucosal healing has been proposed as a goal of therapy because clinical symptoms are subjective. Evaluative indices that measure endoscopic disease activity are required to define mucosal healing for clinical trials. The primary objective of this systematic review was to assess the existing evaluative indices that measure disease activity in CD and evaluate their role as outcome measures in clinical trials. Methods: A systematic literature review was performed using MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and DDW abstracts to identify randomized controlled trials and controlled clinical trials that used a relevant evaluative index from inception to February 2013. The data obtained from these trials were reviewed and summarized. Results: The initial literature searches identified 2300 citations. After duplicates were removed, 1454 studies remained. After application of the apriori inclusion and exclusion criteria, 109 articles were included and 3 were identified with handsearches. In total, 9 evaluative indices for CD were identified and reviewed. The Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score in Crohn's Disease (SES-CD) are indices with the most extensively described operating properties. Conclusions: Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for CD. Currently, the CDEIS and SES-CD have the most data regarding operating properties; however, further validation is required.
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