期刊
GASTROENTEROLOGY
卷 148, 期 1, 页码 37-U455出版社
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.gastro.2014.08.003
关键词
GREAT; CDAI; Outcome Measure; IBD Therapy
资金
- AbbVie
- Takeda
- Nestle Health Sciences
- Santarus
- Prometheus Laboratories
- Abbott Laboratories
- ActoGeniX
- 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
- KaloBios Pharmaceuticals
- Lexicon Pharmaceuticals
- Lycera Corp
- Meda Pharmaceuticals
- Merck Research Laboratories
- Merck Serono
- Millennium Pharmaceuticals
- Nisshin Kyorin Pharmaceuticals
- Novo Nordisk
- NPS Pharmaceuticals
- Optimer Pharmaceuticals
- Orexigen Therapeutics Inc
- PDL BioPharma
- Pfizer Inc
- Procter Gamble
- ProtAb Ltd
- PurGenesis Technologies Inc
- Relypsa Inc
- Roche
- Salient Pharmaceuticals
- Salix Pharmaceuticals
- Schering-Plough Corp
- 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
- Genentech
- Janssen
- Novartis
- Merck
- Novartis Pharmaceuticals
- Centocor Inc
- Elan/Biogen
- Wyeth Pharmaceuticals
- Centocor
- Janssen-Ortho
- AstraZeneca
- Serono
- Unity Pharmaceuticals
- Albireo Pharma
- Prometheus Therapeutics and Diagnostics
- Athersys
- Axcan
- Shire
- Zealand Pharma
- Zyngenia
- gIcare Pharma
- Sigmoid Pharma
- Avaxia Biologics
- Janssen Biotech
- Luitpold Pharmaceuticals
- MedImmune
- PureTech Ventures
- Salix
- TopiVert Pharma Ltd
- Vedanta Biosciences
- Janssen RD
It is important to have clear goals for treating inflammatory bowel disease in clinical practice and in research. Conventional end points for trials in ulcerative colitis and Crohn's disease have been based on composite indices, such as the Mayo Clinic Score and the Crohn's Disease Activity Index; these indices incorporate symptoms, signs, and findings from laboratory tests and sometimes endoscopic assessments. Although definitions of clinical response and remission have been based on these indices for regulatory purposes, they are difficult to apply to practice because they are complex and not intuitive to clinicians. This has caused a disconnect between clinical trials and practice. Recently, the use of composite indices in trials has been reevaluated in Food and Drug Administration-sponsored Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics workshops due to concerns about the validity of the indices. Alternative measures of outcome and definitions of response are being developed. Patient-reported outcomes are psychometric instruments created and defined by patients to quantify symptoms. A combination of end points, comprising patient-reported outcomes and objective evaluation of inflammation by endoscopy, offers a clinically meaningful and scientifically valid alternative to existing composite indices. Unlike composite indices, response definitions based on endoscopy and patient-reported outcomes can be readily applied in practice. This convergence of outcome assessment in clinical trials and practice could expedite implementation of treat-to-target algorithms, in which therapy is progressively intensified until a specific treatment goal is reached. This approach could improve patient care by reducing rates of disease-related complications, surgery, and hospitalization.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据