期刊
INFLAMMATORY BOWEL DISEASES
卷 20, 期 11, 页码 2092-2103出版社
OXFORD UNIV PRESS INC
DOI: 10.1097/MIB.0000000000000155
关键词
Crohn's disease; histology; indices; outcome measures; disease activity; clinical trials; systematic review
资金
- 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
- Chemo-Centryx
- CoMentis
- Cosmo Technologies
- Coronado Biosciences
- sCytokine Pharmascience
- Eagle Pharmaceuticals
- EnGene Inc
- Eli Lilly
- Enteromedics
- Exagen Diagnostics Inc.
- Ferring Pharmaceuticals
- Flexio Therapeutics Inc.
- Funxional Therapeutics Ltd
- Genzyme Corp.
- Gilead Sciences
- Given Imaging
- GSK
- Human Genome Sciences
- Ironwood Pharmaceuticals
- KaloBios Pharmaceuticals
- Lexicon Pharmaceuticals
- Lycera Corp.
- Meda 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
- Tillotts Pharma AG
- TxCell SA
- UCB Pharma
- Viamet Pharmaceuticals
- Vascular Biogenics Ltd.
- Warner Chilcott UK Ltd.
- Wyeth
- BristolMyers Squibb
- Genentech
- Janssen
- Milennium Pharmaceuticals
- Novartis
Background: Crohn's disease (CD) is an idiopathic, chronic, transmural inflammatory disorder of the gastrointestinal tract. Because mucosal involvement is near-universal, endoscopic healing has emerged as an important aspect in improving outcome. However, resolution of histologic disease activity has potential to convey additional benefit beyond that attained with endoscopic healing alone. Validated scoring systems of histologic disease activity are required to further assess this possibility. The aim of this study was to systematically review the existing histologic disease activity indices (HDAI) for CD and to assess their operating properties and potential use as outcome measures in clinical trials. Methods: MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and Digestive Disease Week (DDW) abstracts were searched from 1981 to April 2013 for applicable studies to identify relevant studies for review and analysis. Results: In total, 3732 citations were screened to obtain 89 articles for inclusion. Sixty-six HDAIs were characterized as either stepwise or numerical instruments. These HDAIs were used for either assessment of response to medical therapy or for comparison with biomarkers or imaging tests. None of the HDAIs identified was developed according to currently accepted methods for developing evaluative instruments, and none have been formally validated. Conclusions: Measurement of histologic disease activity has potential value in CD; however, no validated measures are available. Additional research is needed to develop a methodologically rigorous instrument for use in clinical investigation and potentially for clinical practice.
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