Top-down therapy for IBD: Rationale and requisite evidence

Nature Reviews Gastroenterology and Hepatology

Volumn 7, Issue 2, 2010, Pages 86-92

  D'Haens, Geert R ^a  

^a IMELDA HOSPITAL   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; AMINOSALICYLIC ACID DERIVATIVE; AZATHIOPRINE; CERTOLIZUMAB PEGOL; CORTICOSTEROID; GLUCOCORTICOID; IMMUNOMODULATING AGENT; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; MERCAPTOPURINE; METHOTREXATE; METRONIDAZOLE; NATALIZUMAB; PLACEBO; QUINOLINE DERIVED ANTIINFECTIVE AGENT; TUMOR NECROSIS FACTOR ANTIBODY;

ANTIINFLAMMATORY ACTIVITY; BONE NECROSIS; CATARACT; CLINICAL PROTOCOL; CLINICAL TRIAL; CROHN DISEASE; CYTOMEGALOVIRUS INFECTION; DISEASE COURSE; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; ENTERITIS; FISTULA; HEALING; HOSPITALIZATION; HUMAN; HYPERTENSION; IMMUNOSUPPRESSIVE TREATMENT; IMPAIRED GLUCOSE TOLERANCE; INCREASED APPETITE; INSOMNIA; INTESTINE MUCOSA; INTESTINE RESECTION; IRRITABILITY; LEUKOPENIA; LIVER DYSFUNCTION; LIVER VEIN OBSTRUCTION; MOON FACE; OPPORTUNISTIC INFECTION; OSTEOPOROSIS; PANCREATITIS; PATIENT SELECTION; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; PROCTOCOLECTOMY; RECURRENT DISEASE; REVIEW; RHEUMATOID ARTHRITIS; RHEUMATOLOGY; SIDE EFFECT; T CELL LYMPHOMA; THROMBOCYTOPENIA; TREATMENT RESPONSE; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT; VEIN OCCLUSION; VIRUS INFECTION;

EVIDENCE-BASED MEDICINE; GASTROINTESTINAL AGENTS; HUMANS; IMMUNOLOGIC FACTORS; IMMUNOSUPPRESSIVE AGENTS; INFLAMMATORY BOWEL DISEASES;

EID: 76949095663     PISSN: 17595045     EISSN: 17595053     Source Type: Journal    
DOI: 10.1038/nrgastro.2009.222     Document Type: Review

References (64)

1. Baumgart, D. C. & Carding, S. R. Inflammatory bowel disease: cause and immunobiology. Lancet 369, 1627-1640 (2007).
2. Baumgart, D. C. & Sandborn, W. J. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet 369, 1641-1657 (2007).
3. Munkholm, P., Langholz, E., Davidsen, M. & Binder, V. Disease activity courses in a regional cohort of Crohn's disease patients. Scand. J. Gastroenterol. 30, 699-706 (1995).
4. Munkholm, P., Langholz, E., Davidsen, M. & Binder, V. Intestinal cancer risk and mortality in patients with Crohn's disease. Gastroenterology 105, 1716-1723 (1993).
5. Rutgeerts, P. et al. Predictability of the postoperative course of Crohn's disease. Gastroenterology 99, 956-963 (1990).
6. Langholz, E., Munkholm, P., Davidsen, M., Nielsen, O. H. & Binder, V. Changes in extent of ulcerative colitis: a study on the course and prognostic factors. Scand. J. Gastroenterol. 31, 260-266 (1996).
7. Langholz, E., Munkholm, P., Davidsen, M. & Binder, V. Course of ulcerative colitis: analysis of changes in disease activity over years. Gastroenterology 107, 3-11 (1994).
8. Gupta, R. B. et al. Histologic inflammation is a risk factor for progression to colorectal neoplasia in ulcerative colitis: a cohort study. Gastroenterology 133, 1099-1105 (2007).
9. D'Haens, G. R. et al. Early lesions of recurrent Crohn's disease caused by infusion of intestinal contents in excluded ileum. Gastroenterology 114, 262-267 (1998).
10. Stange, E. F. & Travis, S. P. The European consensus on ulcerative colitis: new horizons? Gut 57, 1029-1031 (2008).
11. Eaden, J., Abrams, K., Ekbom, A., Jackson, E. & Mayberry, J. Colorectal cancer prevention in ulcerative colitis: a case-control study. Aliment. Pharmacol. Ther. 14, 145-153 (2000).
12. Travis, S. P. et al. European evidence based consensus on the diagnosis and management of Crohn's disease: current management. Gut 55 (Suppl. 1), i16-i35 (2006).
13. Mekhjian, H. S., Switz, D. M., Melnyk, C. S., Rankin, G. B. & Brooks, R. K. Clinical features and natural history of Crohn's disease. Gastroenterology 77, 898-906 (1979).
14. Ramadas, A. V., Gunesh, S., Thomas, G., Williams, G. T. & Hawthorne, A. B. Reduced Crohn's resections with increasing immunosuppressant use in a population-based Crohn's disease cohort in Cardiff [abstract]. Gut 58 (Suppl. 2), A26 (2009).
15. Greenstein, A. J. et al. Perforating and nonperforating indications for repeated operations in Crohn's disease: evidence for two clinical forms. Gut 29, 588-592 (1988).
16. Edwards, F. C. & Truelove, S. C. The course and prognosis of ulcerative colitis: part 1: short-term prognosis. Gut 4, 300-308 (1963).
17. Järnerot, G., Rolny, P. & Sandberg-Gertzén, H. Intensive intravenous treatment of ulcerative colitis. Gastroenterology 89, 1005-1013 (1985).
18. Yu, E. D., Shao, Z. & Shen, B. Pouchitis. World J. Gastroenterol. 13, 5598-5604 (2007).
19. Cohen, R. D., Brodsky, A. L. & Hannauer, S. B. A comparison of the quality of life in patients with severe ulcerative colitis after total colectomy versus medical treatment with intravenous cyclosporin. Inflamm. Bowel Dis. 5, 1-10 (1999).
20. Breedveld, F. C. et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 54, 26-37 (2006).
21. Goekoop-Ruiterman, Y. P. et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum. 52, 3381-3390 (2005).
22. D'Haens, G. et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet 371, 660-667 (2008).
23. Colombel, J. F. et al. SONIC: a randomized, double-blind, controlled trial comparing infliximab and infliximab plus azathioprine to azathioprine in patients naïve to immunomodulators and biologic therapy [abstract]. Gut 57 (Suppl. 2), A1 (2009).
24. Markowitz, J., Grancher, K., Kohn, N., Lesser, M. & Daum, F. A multicenter trial of 6-mercaptopurine and prednisone in children with newly diagnosed Crohn's disease. Gastroenterology 119, 895-902 (2000).
25. Candy, S. et al. Controlled double blind study of azathioprine in the management of Crohn's disease. Gut 37, 674-678 (1995).
26. Schreiber, J. F. et al. Recent onset Crohn's disease shows higher remission rates and durability of response to treatment with subcutaneous monthly certolizumab pegol: results from an analysis of the PRECiSE 2 Phase III Study [abstract]. Gut 55 (Suppl. 5), A131 (2006).
27. Schreiber, S. et al. Early Crohn's disease shows high levels of remission to therapy with adalimumab: sub-analysis of CHARM [abstract]. Gastroenterology 132 (Suppl. 2), A147 (2007).
28. Froslie, K. F., Jahnsen, J., Moum, B. A. & Vatn, M. H. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology 133, 412-422 (2007).
29. Kugathasan, S. et al. Mucosal T-cell immunoregulation varies in early and late inflammatory bowel disease. Gut 56, 1696-1705 (2007).
30. Baert, F. et al. Mucosal healing predicts sustained clinical remission in early Crohn's disease [abstract]. Gastroenterology 134 (Suppl. 1), A640 (2008).
31. Rutgeerts, P. et al. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease. Gastroenterology 126, 402-413 (2004).
32. Louis, E. et al. Infliximab discontinuation in Crohn's disease patients in stable remission on combined therapy with immunosuppressor: interim analysis of a prospective cohort study [abstract]. Gut 57 (Suppl. 2), A66 (2008).
33. Van Assche, G. et al. Magnetic resonance imaging of the effects of infliximab on perianal fistulizing Crohn's disease. Am. J. Gastroenterol. 98, 332-339 (2003).
34. Regueiro, M. et al. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology 136, 441-450 (2009).
35. Peyrin-Biroulet, L. et al. Azathioprine and 6-mercaptopurine for the prevention of postoperative recurrence in Crohn's disease: a meta-analysis. Am. J. Gastroenterol. 104, 2089-2096 (2009).
36. Hellers, G. et al. Oral budesonide for prevention of postsurgical recurrence in Crohn's disease. The IOIBD Budesonide Study Group. Gastroenterology 116, 294-300 (1999).
37. Sands, B. E. et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N. Engl. J. Med. 350, 876-885 (2004).
38. Colombel, J. F. et al. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut 58, 940-948 (2009).
39. Caprilli, R. et al. European evidence based consensus on the diagnosis and management of Crohn's disease: special situations. Gut 55 (Suppl. 1), i36-i58 (2006).
40. Feagan, B. A. et al. Randomized, placebocontrolled study to evaluate the efficacy of infliximab in combination with methotrexate for the long-term treatment of Crohn's disease [abstract]. Gastroenterology 134 (Suppl. 1), 682C (2008).
41. Aratari, A. et al. Early versus late surgery for ileocaecal Crohn's disease. Aliment. Pharmacol. Ther. 26, 1303-1312 (2007).
42. Kennedy, E. D. et al. Azathioprine or ileocolic resection for steroid-dependent terminal ileal Crohn's disease? A Markov analysis. Dis. Colon Rectum 47, 2120-2130 (2004).
43. Triantafillidis, J. K., Nasioulas, G. & Kosmidis, P. A. Colorectal cancer and inflammatory bowel disease: epidemiology, risk factors, mechanisms of carcinogenesis and prevention strategies. Anticancer Res. 29, 2727-2737 (2009).
44. Reinisch, W. et al. Infliximab treatment for ulcerative colitis: comparable clinical response, clinical remission and mucosal healing in patients with disease duration 3 years [abstract]. Gastroenterology 134, A495 (2008).
45. Derijks, L. J., Gilissen, L. P., Hooymans, P. M. & Hommes, D. W. Review article: thiopurines in inflammatory bowel disease. Aliment. Pharmacol. Ther. 24, 715-729 (2006).
46. Beaugerie, L. et al. Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Lancet 374, 1617-1625 (2009).
47. Siegel, C. A., Hur, C., Korzenik, J. R., Gazelle, G. S. & Sands, B. E. Risks and benefits of infliximab for the treatment of Crohn's disease. Clin. Gastroenterol. Hepatol. 4, 1017-1024 (2006).
48. Lichtenstein, G. R. et al. Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin. Gastroenterol. Hepatol. 4, 621-630 (2006).
49. Colombel, J. F. et al. The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients. Gastroenterology 126, 19-31 (2004).
50. Blonski, W. & Lichtenstein, G. R. Complications of biological therapy for inflammatory bowel diseases. Curr. Opin. Gastroenterol. 22, 30-43 (2006).
51. D'Haens, G. Risks and benefits of biologic therapy for inflammatory bowel diseases. Gut 56, 725-732 (2007).
52. Beaugerie, L., Seksik, P., Nion-Larmurier, I., Gendre, J. P. & Cosnes, J. Predictors of Crohn's disease. Gastroenterology 130, 650-656 (2006).
53. Loly, C., Belaiche, J. & Louis, E. Predictors of severe Crohn's disease. Scand. J. Gastroenterol. 43, 948-954 (2008).
54. Sutherland, L. R., Ramcharan, S., Bryant, H. & Fick, G. Effect of cigarette smoking on recurrence of Crohn's disease. Gastroenterology 98, 1123-1128 (1990).
55. Franchimont, D. P., Louis, E., Croes, F. & Belaiche, J. Clinical pattern of corticosteroid dependent Crohn's disease. Eur. J. Gastroenterol. Hepatol. 10, 821-825 (1998).
56. Lichtenstein, G. R. et al. Factors associated with the development of intestinal strictures or obstructions in patients with Crohn's disease. Am. J. Gastroenterol. 101, 1030-1038 (2006).
57. Abreu, M. T. et al. Mutations in NOD2 are associated with fibrostenosing disease in patients with Crohn's disease. Gastroenterology 123, 679-688 (2002).
58. Henckaerts, L. et al. Genetic risk profiling and prediction of disease course in Crohn's disease patients. Clin. Gastroenterol. Hepatol. 7, 972-980.e2 (2009).
59. Alvarez-Lobos, M. et al. Crohn's disease patients carrying Nod2/CARD15 gene variants have an increased and early need for first surgery due to stricturing disease and higher rate of surgical recurrence. Ann. Surg. 242, 693-700 (2005).
60. Radlmayr, M., Török, H. P., Martin, K. & Folwaczny, C. The c-insertion mutation of the NOD2 gene is associated with fistulizing and fibrostenotic phenotypes in Crohn's disease. Gastroenterology 122, 2091-2092 (2002).
61. Büning, C. et al. Mutations in the NOD2/CARD15 gene in Crohn's disease are associated with ileocecal resection and are a risk factor for reoperation. Aliment. Pharmacol. Ther. 19, 1073-1078 (2004).
62. Ferrante, M. et al. New serological markers in inflammatory bowel disease are associated with complicated disease behaviour. Gut 56, 1394-1403 (2007).
63. Dubinsky, M. C. et al. Serum immune responses predict rapid disease progression among children with Crohn's disease: immune responses predict disease progression. Am. J. Gastroenterol. 101, 360-367 (2006).
64. Bewtra, M. & Lewis, J. D. Safety profile of IBD: lymphoma risks. Gastroenterol. Clin. North Am. 38, 669-689 (2009).