Natalizumab: A promising treatment for Crohn's disease

Expert Review of Clinical Immunology

Volumn 2, Issue 5, 2006, Pages 677-689

  Colombel, Jean Frédéric ^a   Peyrin Biroulet, Laurent ^b  

^a LILLE UNIVERSITY HOSPITAL   (France)

^b CHU NANCY BRABOIS   (France)

Author keywords

Biologic therapy; Crohn's disease; Leukocyte trafficking; Natalizumab; Remission; Steroid sparing

Indexed keywords

EID: 33847661829     PISSN: 1744666X     EISSN: 17448409     Source Type: Journal    
DOI: 10.1586/1744666X.2.5.677     Document Type: Article

References (67)

1. Loftus EV. Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, and environmental influences. Gastroenterology 126, 1504-1517 (2004).
2. Hanauer SB, Sandborn W. Management of Crohn's disease in adults. Am. J. Gastroenterol. 96, 635-643 (2001). (Pubitemid 32240709)
3. Travis SP, Stange EF, Lemann M et al. European evidence based consensus on the diagnosis and management of Crohn's disease: current management. Gut 55(Suppl. 1), 6-35 (2006).
4. Fraser AG, Orchard TR, Jewell DP. The efficacy of azathioprine for the treatment of inflammatory bowel disease: a 30 year review. Gut 50, 485-489 (2002). (Pubitemid 34638866)
5. Lemann M, Mary JY, Colombel JF et al. A randomized, double-blind, controlled withdrawal trial in Crohn's disease patients in long-term remission on azathioprine. Gastroenterology 128(7), 1812-1818 (2005). (Pubitemid 40824692)
6. Kandiel A, Fraser AG, Korelitz BI et al. Increased risk of lymphoma among inflammatory bowel disease patients treated with azathioprine and 6-mercaptopurine. Gut 54(8), 1121-1125(2005). (Pubitemid 41025906)
7. Hanauer SB, Feagan BG, Lichtenstein GR et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomized trial. Lancet 359, 1541-1549 (2002). (Pubitemid 34621118)
8. Baert F, Norman M, Vermeire S et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N. Engl. J. Med. 348, 601-608 (2003). (Pubitemid 36204954)
9. Bongartz T, Sutton AJ, Sweeting MJ et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 17, 2275-2285 (2006). (Pubitemid 43736578)
10. Sandborn WJ. Treatment of Crohn's disease. In: Kirsner's Inflammatory Bowel Disease, 6th Edition. Sartor R, Sandborn WJ (Eds). Elsevier Science, FL, USA (2004).
11. Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 54, 237-241 (2005). (Pubitemid 40139240)
12. Rutgeerts P. A critical assessment of new therapies in inflammatory bowel disease. J. Gastroenterol. Hepatol. 17, 176-185 (2002).
13. Cosnes J, Cattan S, Blain A et al. Long-term evolution of disease behavior of Crohn's disease. Inflamm. Bowel Dis. 8, 244-250 (2002). (Pubitemid 34784976)
14. Hay AR, Hay JW. Inflammatory bowel disease: Medical cost algorithms, J. Clin. Gastroenterol 14, 318-327 (1992).
15. Vermeire S, Rutgeerts P. Novel biologic strategies in inflammatory bowel diseases. Inflamm. Bowel Dis. 10, 44-51 (2004).
16. Hemler ME, Elices MJ, Parker C, Takada Y. Structure of the integrin VLA-4 and its cell-cell and cell-matrix adhesion functions. Immunol Rev. 114, 45-65 (1990). (Pubitemid 20141069)
17. Hynes RO. Integrins: versatility, modulation, and signaling in cell adhesion. Cell 69, 11-25 (1992).
18. Lobb RR, Hemler ME. The patho-physiologic role of α4 integrins in vivo. J. Clin. Invest. 94, 1722-1728 (1994).
19. Springer TA. Traffic signals for lymphocyte recirculation and leukocyte emigration: the multistep paradigm. Cell 76, 301-314 (1994). (Pubitemid 24046692)
20. Bevilacqua MP. Endothelial-leukocyte adhesion molecules. Ann. Rev. Immunol. 11, 767-804 (1993). (Pubitemid 23115023)
21. Postigo AA, Teixido J, Sanchez-Madrid F. The α 4 β1/VCAM-1 adhesion pathway in physiology and disease. Res. Immunol. 144, 723-735 (1993). (Pubitemid 24055717)
22. Sandborn WJ, Yednock TA. Novel approaches to treating inflammatory bowel disease: targeting a-4 integrin. Am. J. Gastroenterol. 98, 2372-2382 (2003). (Pubitemid 37448744)
23. Lindenboom K, Brazier G. Millennium Pharmaceuticals Announces Phase II Data for MLN02 in Crohn's Disease. Millennium Pharmaceuticals, MA, USA (2002).
24. Feagan B, Greenberg G, Wild G et al. Treatment of ulcerative colitis with a humanized antibody to α4β7 integrin. New. Engl. J. Med. 352, 2499-2507 (2005). (Pubitemid 41007865)
25. Yacyshyn BR, Bowen-Yacyshyn MB, Jewell L et al. A placebo-controlled trial of ICAM-1 antisense oligonucleotide in the treatment of Crohn's disease. Gastroenterology 114, 1133-1142 (1998). (Pubitemid 28243898)
26. Schreiber S, Nikolaus S, Malchow H et al. Absence of efficacy of subcutaneous antisense ICAM-1 treatment of chronic active Crohn's disease. Gastroenterology 120, 1339-4136(2001).
27. van Deventer SJ, Tami JA, Wedel MK. A randomised, controlled, double blind, escalating dose study of alicaforsen enema in active ulcerative colitis. Gut. 53, 1646-1651 (2004). (Pubitemid 39434109)
28. van Deventer SJ, Wedel MK, Baker BF et al A phase II dose ranging, double-blind, placebo-controlled study of alicaforsen enema in subjects with acute exacerbation of mild to moderate left-sided ulcerative colitis. Ailment Pharmacol. Ther. 23, 1415-1425 (2006).
29. Leger OJ, Yednock TA, Tanner L et al. Humanization of a mouse antibody against human α-4 integrin: a potential therapeutic for the treatment of Mult. Scler. Hum. Antibodies 8, 3-16 (1997). (Pubitemid 27397156)
30. Mountain A, Adair JR. Engineering antibodies for therapy. Biotechnol. Genet. Eng. Rev. 10, 1-142 (1992).
31. Kent SJ, Karlik SJ, Cannon C et al. A monoclonal antibody to α 4 integrin suppresses and reverses active experimental allergic encephalomyelitis. J. Neuroimmunol. 58, 1-10 (1995).
32. Podolsky DK, Lobb R, King N et al. Attenuation of colitis in the cotton-top tamarin by anti-α 4 integrin monoclonal antibody. J. Clin. Invest. 92, 372-380 (1993). (Pubitemid 23209018)
33. Hesterberg PE, Winsor-Hines D, Briskin MJ et al. Rapid resolution of chronic colitis in the cotton-top tamarin with an antibody to a gut-homing integrin α4β. Gastroenterology 111, 1373-1380 (1996). (Pubitemid 26362264)
34. Gordon FH, Pounder RE, Amlot PL et al. The effect of natalizumab, a humanized monoclonal antibody to the α4 integrin on circulating activated leucocytes in active inflammatory bowel disease (IBD). Gastroenterology 122, A434 (2002).
35. Gordon FH, Lai CW, Hamilton MI et al. A randomized placebo-controlled trial of a humanized monoclonal antibody to α4 integrin in active Crohn's disease. Gastroenterology 121, 268-274 (2001). (Pubitemid 32729374)
36. Gordon FH, Hamilton MI, Donoghue S et al. A pilot study of treatment of active ulcerative colitis with natalizumab, a humanized monoclonal antibody to α-4 integrin. Ailment Pharmacol. Ther. 16, 699-705 (2002). (Pubitemid 34407517)
37. Ghosh S, Goldin E, Gordon FH et al. Natalizumab for active Crohn's disease. N. Engl J. Med. 348, 24-32 (2003). (Pubitemid 36026343)
38. Sandborn WJ, Colombel J-F, Enns R et al. Natalizumab induction and maintenance therapy for Crohn's disease. N. Engl. J. Med. 353, 1912-1925 (2005). (Pubitemid 41565956)
39. Grundy J, Pan W, Kugathasan S et al. Pharmacokinetics and pharmacodynamics of natalizumab in a Phase 2 study of adolescent patients with Crohn's disease. Proceedings of the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition, 2004. Salt Lake City, UT, USA (2005).
40. Sands B, Kozarek R, Spainhour J et al. Safety and efficacy of natalizumab in patients concurrently receiving infliximab in a phase 2 study of active Crohn's disease. Am. J. Gastroenterol. 99, 526 (2004).
41. Sheremata WA, Vollmer TL, Stone LA et al. A safety and pharmacokinetic study of intravenous natalizumab in patients with MS. Neurology 52(5), 1072-1074 (1999). (Pubitemid 29161624)
42. van Deventer S, Rutgeerts P, Rask-Madsen J et al. Pharmacokinetics (PK) and pharmacodynamics (PD) of natalizumab in active Crohn's disease patients. Gastroenterology 122, 433 (2002).
43. Bennett D, Ludden T, Shah J et al. The use of pharmacokinetic (PK) modeling and efficacy data to establish optimal dosing of natalizumab (Antegren). Mult. Scler. 8, 130 (2002).
44. Panaccione R, Colombel JF, Enns R et al. Comparability of natalizumab pharmacokinetics (PK), α4 integrin receptor saturation, and clinical response in patients with Crohn's disease (CD) treated once monthly IV with either a fixed dose of 300 mg (ENACT-1) or doses of 3 or 6 mg/kg. Gastroenterology 126, A584 (2003).
45. Targan S, Feagan B, Fedorak B et al. Natalizumab induces durable response in patients with active Crohn's disease: results from the ENCORE trial. Gastroenterology 130, A108 (2006).
46. Poullis AP, Zar S, Sundaram KK et al. A new, highly sensitive assay for C-reactive protein can aid the differentiation of inflammatory bowel disorders from constipation-and diarrhoea-predominant functional bowel disorders. Eur. J. Gastroenterol Hepatol. 14, 409-412 (2002). (Pubitemid 34439041)
47. Sandborn W, Colombel JF, Enns R et al. Maintenance therapy with natalizumab does not require use of concomitant immunosuppressants for sustained efficacy in patients with active Crohn's disease: results from the ENACT-2 study. Gastroenterology 130, A482 (2006).
48. Colombel J, Enns R, Feagan B et al. 12-month steroid-sparing results of natalizumab in a controlled study of patients with Crohn's disease. Gastroenterology 128, A576 (2005).
49. Feagan B, Colombel JF, Enns R et al Maintenance treatment with natalizumab improves the health related quality of life (HRQOL) in Crohn's disease patients. Gastroenterology 130, A48 (2006).
50. Feagan B, Enns R, Colombel JF et al. Natalizumab improves the health related quality of life (HRQOL) in Crohn's disease patients. Am. J. Gastroenterol 100, 310 (2005).
51. Feagan B, Enns R, Colombel JF et al. Maintenance natalizumab results in greater quality of life in Crohn's disease patients. Gut. 54, A18 (2005).
52. Rutgeerts P, Allison MC, Cortot A et al. Effects of natalizumab on gut healing in a phase 3 study of active Crohn's disease therapy (ENACT-I). Gastroenterology 126, A208 (2004).
53. Geboes K, Allison MC, Cortot A et al. Natalizumab decreases inflammatory cells within the colonic lamina propria of patients with active Crohn's disease: results from ENACT-I. Gastroenterology 126, A213 (2004).
54. Wilson DC, Thomas AG, Mitchell B et al. Safety, tolerability, immunogenicity and efficacy of natalizumab in adolescents with moderately to severely active Crohn's disease: an open-label study. Gut. 53, A48 (2004).
55. Hyams J, Wilson D, Thomas A et al. An open-label safety, tolerability, and efficacy study of natalizumab in adolescents with moderately to severely active Crohn's disease. Am. J. Gastroenterol. 99, 256 (2004).
56. Sandborn WJ, Hanauer, SB, Lucas M et al. Maintenance of remission over 1 year in patients with active Crohn's disease treated with adalimumab: results of CLASSIC II, a blinded, placebo-controlled study. Gut 54, A81 (2005).
57. Colombel JF, Sandborn WJ, Rutgeerts R et al. Adalimumab induces and maintains clinical response and remission in patients with active Crohn's disease: results of the CHARM trial. Presented at Digestive Diseases Week, Los Angeles, CA, USA. Late Breaking Abstract 686d (2006).
58. Van Assche G, Van Ranst M, Sciot R et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N. Engl. J. Med. 353, 362-368 (2005). (Pubitemid 41132340)
59. Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon β-1 a for multiple sclerosis. N. Engl. J. Med. 353, 369-374 (2005). (Pubitemid 41132341)
60. Langer-Gould A, Atlas SW, Green AJ et al. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N. Engl J. Med. 353, 375-381 (2005). (Pubitemid 41132342)
61. Yousry TA, Major E, Ryschkewitsch C et al. Evaluation for progressive multifocal leukoencephalopathy in natalizumab treated patients. N. Engl. J. Med. 354, 924-33 (2006).
62. Podolsky DK. Selective adhesion-molecule therapy and inflammatory bowel disease - a tale of Janus? N. Engl. J. Med. 353, 1965-1968 (2005). (Pubitemid 41565962)
63. Ropper AH. Selective treatment of multiple sclerosis. N. Engl J. Med. 354, 965-967 (2006).
64. Hanauer SB, Korelitz BI, Rutgeerts P et al. Postoperative maintenance of Crohn's disease remission with 6-mercaptopurine, mesalamine, or placebo: a 2-year trial. Gastroenterology 127, 723-729 (2004). (Pubitemid 39208405)
65. Rutgeerts PJ. An historical overview of the treatment of Crohn's disease: why do we need biological therapies? Rev. Gastroenterol. Disorders. 4, 3-9 (2004).
66. D'Haens G, van Deventer S, van Hogezand R et al. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: a European multicenter trial. Gastroenterology 116, 1029-1034 (1999). (Pubitemid 29203012)
67. Ahmad T, Tamboli CP, Jewell D, Colombel JE Clinical relevance of advances in genetics and pharmacogenetics of IBD. Gastroenterology 126, 1533-1549 (2004). (Pubitemid 38649871)