期刊
INFLAMMATORY BOWEL DISEASES
卷 19, 期 8, 页码 1645-1653出版社
OXFORD UNIV PRESS INC
DOI: 10.1097/MIB.0b013e318283a4b3
关键词
clinical trials; Crohn's disease; disease activity measurements; mucosal healing; serologic markers; testing
资金
- AbbVie
- Amgen
- AstraZeneca
- Axcan Pharma (now Aptalis)
- Biogen Idec
- Bristol-Myers Squibb
- Centocor
- ChemoCentryx
- Eisai Medical Research Inc
- Elan Pharmaceuticals
- Ferring Pharmaceuticals
- Genetech
- GlaxoSmithKline
- Janssen
- Millennium Pharmaceuticals Inc (now Takeda)
- Merck Sharp and Dohme Corp
- Ocera Therapeutics Inc
- Otsuka America Pharmaceutical
- Pfizer
- Shire Pharmaceuticals
- Prometheus Laboratories
- Schering-Plough
- Synta Pharmaceuticals Corp
- Teva
- UCB Pharma
- Warner Chilcott
- ActoGeniX
- Albireo Pharma
- Bayer AG
- Boehringer Ingelheim GmbH
- Cellerix
- Cosmo Technologies
- Danone Research
- Giuliani SpA
- Given Imaging
- Hutchison MediPharma
- Neovacs
- Sanofi-Aventis
- Therakos
- Tillotts Pharma
- Wyeth
- Dr Falk Pharma
- Millenium (now Takeda)
- MSD
- Actelion
- Celgene
- Merck
- Mitsubishi
- Norgine
- Pharmacosmos
- Pilege
- Tillotts Pharma AG
- Vifor
- ActoGeniX NV
- AGI Therapeutics, Inc
- Alba Therapeutics Corporation
- Albireo
- Alfa Wasserman
- AM-Pharma BV
- Anaphore
- Astellas Pharma
- Athersys, Inc
- Atlantic Healthcare Limited
- BioBalance Corporation
- Boehringer Ingelheim Inc
- Celegene
- Celek Pharmaceuticals
- Cellerix SL
- Cerimon Pharmaceuticals
- CoMentis
- Coronado Biosciences
- Cytokine Pharmasciences
- Eagle Pharmaceuticals
- EnGene Inc
- Eli Lilly
- Enteromedics
- Exagen Diagnostics Inc
- Ferring PharmaceFerring Pharmaceuticals, Flexion Therapeutics Incuticals
- Funxional Therapeutics Limited
- Genzyme Corporation
- Genentech (now Roche)
- Gilead Sciences
- Human Genome Sciences
- Ironwood Pharmaceuticals (previously Microbia Inc)
- Janssen (previously Centocor)
- KaloBios Pharmaceuticals Inc
- Lexicon Pharmaceuticals
- Lycera Corporation
- Meda Pharmaceuticals (previously Alaven Pharmaceuticals)
- Merck Research Laboratories
- MerckSerono
- Millennium Pharmaceuticals (subsequently merged with Takeda)
- Nisshin Kyorin Pharmaceuticals Co Ltd
- Novo Nordisk A/S
- NPS Pharmaceuticals
- Optimer Pharmaceuticals
- Orexigen Therapeutics Inc
- PDL Biopharma
- Procter Gamble
- Procter & Gamble, Prometheus Laboratories
- ProtAb Limited
- Purgenesis Technologies Inc
- Receptos
- Relypsa Inc
- Salient Pharmaceuticals
- Salix Pharmaceuticals Inc
- Santarus
- Schering-Plough Corporation (acquired by Merck)
- Sigmoid Pharma Limited
- Sirtris Pharmaceuticals Inc (a GSK company)
- S.L.A. Pharma (UK) Limited
- Targacept
- Teva Pharmaceuticals
- Tillotts Pharma AG (acquired by Zeria Pharmaceutical Co Ltd)
- TxCell SA
- Viamet Pharmaceuticals
- Vascular Biogenics Limited
- Warner Chilcott UK Limited
- Wyeth (now Pfizer)
- Procter & Gamble Pharmaceuticals
Background:Using clinical symptoms alone to inform treatment decisions in Crohn's disease (CD) may increase the risk of disease progression and complications. Treatment beyond symptoms may offer improved outcomes.Methods:We explore alternative definitions of remission, beyond traditional clinical remission, incorporating more objective parameters of inflammation control, which may support prevention or delay the disease progression. These definitions could serve as a platform for future clinical research, evaluating whether treating beyond symptoms alters the natural history of CD.Results:Proposed definitions may include endoscopic remission (mucosal healing), normalization of serologic or fecal markers of inflammation, and even radiographic remission, in addition to clinical remission (symptom control). Endoscopic remission is the leading candidate for inclusion because it is the best studied. The definition should include considerations for both early and late disease given that in late disease, which may be associated with operation-related symptoms or irreversible bowel damage, symptomatic remission may not achievable. Desired outcomes in early disease are complete absence of symptoms, no disease progression, no complications or disability, and normal quality of life. In late disease, there are stabilization of noninflammatory symptoms, no progression of damage or disability, and improved quality of life.Conclusions:Over time, we anticipate that a working definition of remission that includes both biological remission and clinical remission will evolve and be evaluated in clinical trials. Our proposed definition is a possible starting point for that evolution. Ultimately, the goal in evolving the definition of remission is to improve the outcomes in patients with CD.
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