4.5 Article

Evolving Definitions of Remission in Crohn's Disease

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

  1. AbbVie
  2. Amgen
  3. AstraZeneca
  4. Axcan Pharma (now Aptalis)
  5. Biogen Idec
  6. Bristol-Myers Squibb
  7. Centocor
  8. ChemoCentryx
  9. Eisai Medical Research Inc
  10. Elan Pharmaceuticals
  11. Ferring Pharmaceuticals
  12. Genetech
  13. GlaxoSmithKline
  14. Janssen
  15. Millennium Pharmaceuticals Inc (now Takeda)
  16. Merck Sharp and Dohme Corp
  17. Ocera Therapeutics Inc
  18. Otsuka America Pharmaceutical
  19. Pfizer
  20. Shire Pharmaceuticals
  21. Prometheus Laboratories
  22. Schering-Plough
  23. Synta Pharmaceuticals Corp
  24. Teva
  25. UCB Pharma
  26. Warner Chilcott
  27. ActoGeniX
  28. Albireo Pharma
  29. Bayer AG
  30. Boehringer Ingelheim GmbH
  31. Cellerix
  32. Cosmo Technologies
  33. Danone Research
  34. Giuliani SpA
  35. Given Imaging
  36. Hutchison MediPharma
  37. Neovacs
  38. Sanofi-Aventis
  39. Therakos
  40. Tillotts Pharma
  41. Wyeth
  42. Dr Falk Pharma
  43. Millenium (now Takeda)
  44. MSD
  45. Actelion
  46. Celgene
  47. Merck
  48. Mitsubishi
  49. Norgine
  50. Pharmacosmos
  51. Pilege
  52. Tillotts Pharma AG
  53. Vifor
  54. ActoGeniX NV
  55. AGI Therapeutics, Inc
  56. Alba Therapeutics Corporation
  57. Albireo
  58. Alfa Wasserman
  59. AM-Pharma BV
  60. Anaphore
  61. Astellas Pharma
  62. Athersys, Inc
  63. Atlantic Healthcare Limited
  64. BioBalance Corporation
  65. Boehringer Ingelheim Inc
  66. Celegene
  67. Celek Pharmaceuticals
  68. Cellerix SL
  69. Cerimon Pharmaceuticals
  70. CoMentis
  71. Coronado Biosciences
  72. Cytokine Pharmasciences
  73. Eagle Pharmaceuticals
  74. EnGene Inc
  75. Eli Lilly
  76. Enteromedics
  77. Exagen Diagnostics Inc
  78. Ferring PharmaceFerring Pharmaceuticals, Flexion Therapeutics Incuticals
  79. Funxional Therapeutics Limited
  80. Genzyme Corporation
  81. Genentech (now Roche)
  82. Gilead Sciences
  83. Human Genome Sciences
  84. Ironwood Pharmaceuticals (previously Microbia Inc)
  85. Janssen (previously Centocor)
  86. KaloBios Pharmaceuticals Inc
  87. Lexicon Pharmaceuticals
  88. Lycera Corporation
  89. Meda Pharmaceuticals (previously Alaven Pharmaceuticals)
  90. Merck Research Laboratories
  91. MerckSerono
  92. Millennium Pharmaceuticals (subsequently merged with Takeda)
  93. Nisshin Kyorin Pharmaceuticals Co Ltd
  94. Novo Nordisk A/S
  95. NPS Pharmaceuticals
  96. Optimer Pharmaceuticals
  97. Orexigen Therapeutics Inc
  98. PDL Biopharma
  99. Procter Gamble
  100. Procter & Gamble, Prometheus Laboratories
  101. ProtAb Limited
  102. Purgenesis Technologies Inc
  103. Receptos
  104. Relypsa Inc
  105. Salient Pharmaceuticals
  106. Salix Pharmaceuticals Inc
  107. Santarus
  108. Schering-Plough Corporation (acquired by Merck)
  109. Sigmoid Pharma Limited
  110. Sirtris Pharmaceuticals Inc (a GSK company)
  111. S.L.A. Pharma (UK) Limited
  112. Targacept
  113. Teva Pharmaceuticals
  114. Tillotts Pharma AG (acquired by Zeria Pharmaceutical Co Ltd)
  115. TxCell SA
  116. Viamet Pharmaceuticals
  117. Vascular Biogenics Limited
  118. Warner Chilcott UK Limited
  119. Wyeth (now Pfizer)
  120. Procter & Gamble Pharmaceuticals

向作者/读者索取更多资源

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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