Natalizumab for the treatment of multiple sclerosis and Crohn's disease

Annals of Pharmacotherapy

Volumn 39, Issue 11, 2005, Pages 1833-1843

  Keeley, Kendra A ^a   Rivey, Michael P ^a,b   Allington, Douglas R ^a  

^a UNIVERSITY OF MONTANA   (United States)

^b P   (United States)

Author keywords

Crohn's disease; Inflammatory bowel disease; Multiple sclerosis; Natalizumab

Indexed keywords

BETA1A INTERFERON; CORTICOSTEROID; NATALIZUMAB; NEW DRUG; PLACEBO;

ABDOMINAL PAIN; ARTHRALGIA; ASTHENIA; BACKACHE; CLINICAL TRIAL; COLITIS; CROHN DISEASE; DEPRESSION; DIZZINESS; DRUG EFFECT; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INFORMATION; DRUG MARKETING; DRUG MECHANISM; DRUG SAFETY; DYSMENORRHEA; FATIGUE; FLU LIKE SYNDROME; HEADACHE; HUMAN; IMMUNOGENICITY; INFECTION; INJURY; INSOMNIA; LIVER DYSFUNCTION; LONG TERM CARE; MENSTRUATION DISORDER; MULTIPLE SCLEROSIS; MYASTHENIA; NAUSEA; NONHUMAN; PAIN; PARESTHESIA; PHARMACODYNAMICS; PHARYNGITIS; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PRURITUS; RELAPSE; REVIEW; RHINITIS; RISK BENEFIT ANALYSIS; SINUSITIS; THORAX DISEASE; TREATMENT OUTCOME; URINARY FREQUENCY; URINARY TRACT INFECTION;

ANIMALS; ANTIBODIES, MONOCLONAL; CLINICAL TRIALS; CROHN DISEASE; HUMANS; META-ANALYSIS; MULTIPLE SCLEROSIS;

EID: 27344455354     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1G134     Document Type: Review

References (63)

1. Polman CH, Uitdehaag BMJ. New and emerging treatment options for multiple sclerosis. Lancet Neurol 2003;2:563-6.
2. Smith CH. Current immunomodulatory therapies for multiple sclerosis. Formulary 2004;Nov(suppl):4-10.
3. Rutgeerts P. Modern therapy for inflammatory bowel disease. Scand J Gastroenterol 2003;38(suppl 237):30-3.
4. Van Assche G, Rutgeerts P. Antiadhesion molecule therapy in inflammatory bowel disease. Inflamm Bowel Dis 2002;8:291-300.
5. Carty E, Rampton DS. Evaluation of new therapies for inflammatory bowel disease. J Clin Pharmacol 2003;56:351-6.
6. Sandborn WJ, Yednock TA. Novel approaches to treating inflammatory bowel disease: targeting α-4 integrin. Am J Gastroenterol 2003;98:2372-82.
7. Rudick RA, Sandrock A. Natalizumab: α4-integrin antagonist selective adhesion molecule inhibitors for MS. Expert Rev Neurotherapeut 2004;4:571-80.
8. Egan LJ, Sandborn WJ. Advances in the treatment of Crohn's disease. Gastroenterology 2004;126:1574-81.
9. Archelos JJ, Previtiali SC, Hartung HP. The role of integrins in immune-mediated diseases of the nervous system. Trends Neurosci 1999;22:30-8.
10. Berlin C, Bargatze RF, Campbell JJ, von Andrian UH, Szabo MC, Hassien SR, et al. α4 Integrins mediate lymphocyte attachment and rolling under physiologic flow. Cell 1995;80:413-22.
11. von Andrian UH, Mackay CR. Advances in immunology: T-cell function and migration: two sides of the same coin. N Engl J Med 2000;343:1020-34.
12. Lee SJ, Benveniste EN. Adhesion molecule expression and regulation on cells of the central nervous system. J Neuroimmunol 1999;98:77-88.
13. Frenette PS, Wagner DD. Adhesion molecules-part II: blood vessels and blood cells. N Engl J Med 1996;335:43-5.
14. Frenette PS, Wagner DD. Adhesion molecules-part 1. N Engl J Med 1996;334:1526-9.
15. Ghosh S. α-4 Integrin blockade in inflammatory bowel disease. Ann Rheum Dis 2003;62(suppl 2):70-2.
16. Hynes RO. Integrins: a family of cell surface receptors. Cell 1987;48:549-54.
17. Lin KC, Castro AC. Very late antigen 4 (VLA4) antagonists as anti-inflammatory agents. Curr Opin Chem Biol 1998;2:453-7.
18. Sorbera LA, Martin L, Rabasseda X. Drugs Future 2000;25:917-21.
19. Natalizumab: AN 100226, anti-4 α-integrin monoclonal antibody. Drugs R D 2004;5:102-7.
20. von Andrian UH, Engelhardt B. α4 Integrins as therapeutic targets in autoimmune disease, N Engl J Med 2003;348:68-72.
21. Tilley JW, Sidduri A. VLA-4 antagonists. Drugs Future 2001;26:985-98.
22. Coles AJ, Wing MG, Molyneux P, Paolillo A, Davie CM, Hale G, et al. Monoclonal antibody treatment exposes three mechanisms underlying the clinical course of multiple sclerosis. Ann Neurol 1999;46:296-304.
23. Vollmer TL, Phillips JT, Goodman AD, Agius MA, Libonati MA, Giacchino JL, et al. An open-label safety and drug interaction study of natalizumab (Antegren) in combination with interferon-beta (Avonex) in patients with multiple sclerosis. Mult Scler 2004;10:511-20.
24. Kent SJ, Karlik SJ, Cannon C, Hines DK, Yednock TA, Fritz LC, et al. A monoclonal antibody to α-4 integrin suppresses and reverses active experimental allergic encephalomyelitis. J Neuroimmunol 1995;58:1-10.
25. Podoisky DK, Lobb R, King N, Benjamin CD, Pepinsky B, Sehgal P, et al. Attenuation of colitis in the cotton-top Tamarin by anti-α4 integrin monoclonal antibody. J Clin Invest 1993;92:372-80.
26. Miller DH, Khan OA, Shermata WA, Bulumhardt LD, Rice GP, Libonati MA, et al. A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2003;348:15-23.
27. Ghosh S, Goldin E, Gordon FH, Malchow HA, Rask-Madsen J, Rutgeerts P, et al. Natalizumab for active Crohn's disease. N Engl J Med 2003;348:24-32.
28. Package insert. Tysabri (natalizumab). Cambridge, MA: Biogen Idee, November 2004.
29. Gordon FH, Hamilton MI, Donoghue S, Greenlees C, Palmer T, Rowley-Jones D, et al. A pilot study of treatment of active ulcerative colitis with natalizumab, a humanized monoclonal antibody to α-4 integrin. Aliment Pharmacol Ther 2002;16:699-705.
30. Carter JL, Agius M, Mass M, Romine JS, Taulor J, Libonati M, et al. A placebo-controlled, pharmacodynamic, pharmacokinetic, tolerability, and safety study of three doses of intravenous natalizumab in multiple sclerosis (abstract s50.003). Neurology 2000;54(suppl 3):A259.
31. Van Deventer SJ, Rutgeerts P, Rask-Madsen J, Shah J, Palmer T, Goldblum R. Pharmacokinetics (PK) and pharmacodynamics (PD) of natalizumab in active Crohn's disease patients (abstract T1212). Gastroenterology 2002;122(suppl 4):A-434.
32. Cuellell-Young M, Mealy NE, Castaner R, Martin L, del Fresno M, Revel L, et al. Gastrointestinal drugs. Drugs Future 2002;27:685-714.
33. O'Connor PW, Goodman A, Willmer-Hulme AJ, Libonati MA, Metz L, Murray RS, et al. Randomized multicenter trial of natalizumab in acute MS relapses: clinical and MRI effects. Neurology 2004;62:2038-43.
34. Shermata WA, Vollmer TL, Stone LA, Willmer-Hulme AJ, Koller M. A safety and pharmacokinetic study of intravenous natalizumab in patients with MS. Neurology 1999;52:1072-4.
35. Gordon FH, Lai CWY, Hamilton MI, Allison MC, Srivastava ED, Fouweather MG, et al. A randomised placebo-controlled trial of humanised monoclonal antibody to α-4 integrin in active Crohn's disease. Gastroenterology 2001;121:268-74.
36. Feagan BG, McDonald J, Greenberg G, Wild G, Pare P, Fedorak RN, et al. An ascending dose trial of a humanized A4B7 antibody in ulcerative colitis (UC) (abstract 4851). Gastroenterology 2000;118(suppl 4):A-874.
37. Bennett D, Ludden T, Shah J, Floren L, Beckman E. The use of pharmacokinetic (PK) modeling and efficacy data to establish optimal dosing of natalizumab (abstract P130). Multiple Sclerosis 2002;8(suppl):S61.
38. Gordon FH, Pounder RE, Amlot PL, Donoghue S. The effect of natalizumab, a humanized monoclonal antibody to α4 integrin on circulating activated leukocytes in active inflammatory bowel disease (IBD) (abstract T1213). Gastroenterology 2002;122(suppl 4):A-434.
39. Lawrance IC, Colombel J-F, Enns RA, Feagan B, Hanauer SB, Panaccione R, et al. Pharmacodynamic results from a phase 3 study evaluation natalizumab therapy of active Crohn's disease (ENACT-I) (abstract 1403). Gastroenterology 2004;126(suppl 2):A-211.
40. Baert F, Noman M, Vermeire S, Van Assche G, D'Haens G, Caibonez A, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003;348:601-8.
41. Turbidity N, Behan PO, Capildeo R, Chaudhuri A, Forbes R, Hawkins CP, et al. The effect of anti-α 4 integrin antibody on brain lesion activity in MS. The UK Antegren Study Group. Neurology 1999;53:466-72.
42. Kurtzke J. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983;33:1444-52.
43. Sipe JC, Knobler RL, Braheny SL, Rice GP, Panitch HS, Oldstone MB. A neurologic rating scale (NRS) for use in multiple sclerosis. Neurology 1984;34:1368-72.
44. Sharrack B, Hughes RAC, Soudain S. Guy's neurological disability scale (abstract). Neurology 1996;243(suppl 2):S32.
45. Minagar A, Shermata WA, Vollmer TL, Willmer-Hulme AJ, Koller M. Reduction of relapses in multiple sclerosis after anti-alpha4 integrin antibody (natalizumab). Int J MS Care [serial online]. Mar 2000;3:1-6. www.mscare.com (accessed 2005 Feb 2).
46. Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index: National Cooperative Crohn's Disease study. Gastroenterology 1976;70:439-44.
47. Powell-Tuck J, Brown RL, Lennard-Jones JE. A comparison of oral prednisolone given as a single or multiple daily doses for active proctocolitis. Scand J Gastroenterol 1978;13:833-7.
48. Irvine J, Feagan B, Rochon J, Archambault A, Fedorak R, Groll A, et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Gastroenterology 1994;106:287-96.
49. Sandborn WJ, Colombel JF, Enns RA, Feagan B, Hanauer SB, Lawrance I, et al. Efficacy of assessment of natalizumab in patients with Crohn's disease and prior history of anti-TNF therapy: results from ENACT-I (abstract 583). Gastroenterology 2004;126(4 suppl 2):A76.
50. Enns RA, Columbel JF, Feagan BG, Hanauer SB, Lawrance I, Panaccione R, et al. Safety, tolerability and immunogenicity of natalizumab in a phase III study of active Crohn's disease therapy ENACT-I (abstract). Gastroenterology 2004;126(4 suppl 2):A462.
51. Sandborn W, Colombel JF, Enns R, Feagan B, Hanauer S, Lawrance I, et al. A phase III, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of Antegren (natalizumab) in maintaining clinical response and remission in Crohn's disease (ENACT-2) (abstract 3). Gastroenterology 2004;127(suppl 1):332.
52. Lobb R, Hemler ME. The pathophysiologic role of cx4 integrins in vivo. J Clin Invest 1994;94:1722-8.
53. Johnston B, Walter UM, Issekutz AC, Issekutz TB, Anderson DC, Kuges P. Differential roles of selectins and the alpha4-integrin in acute, subacute, and chronic leukocyte recruitment in vivo. J Immunol 1997;159:4514-23.
54. Pankaj S, Diaz F, O'Major E. Advances in the biology of JC virus and induction of progressive multifocal leukoencephalopathy. J Neurol 2003;9:236-46.
55. Questions and answers on natalizumab (marketed as Tysabri). U.S. Food and Drug Administration, www.fda.gov/cder/drug/infopage/natalizumab/ natalizumabQA_2_2005.htm (accessed 2005 Apr 13).
56. Suspended marketing of Tysabri (natalizumab). FDA Public Health Advisory. www.fda.gov/cder/drug/advisory/natalizumab.htm (accessed 2005 Mar 1).
57. Langer-Gould A, Atlas S, Green AJ, Bollen A, Pelletier D. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med 2005;353:375-81. Epub 2005 Jun 9.
58. Kleinschmidt-DeMasters B, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-lafor multiple sclerosis. N Engl J Med 2005;353:369-74. Epub 2005 Jun 9.
59. Van Assche G, Van Ranst M, Sciot R, Dubois B, Vermeire S, Noman M, et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N Engl J Med 2005;353:362-8. Epub 2005 Jun 9.
60. Berger JR, Koralnik IJ. Progressive multifocal leukoencephalopathy and natalizumab-unforeseen consequences. N Engl J Med 2005;353:414-6. Epub 2005 Jun 9.
61. Reuters Health Information. Possible fifth Tysabri-related case-WSJ. June 2005. www.medscape.cora/viewarticle/506496 (accessed 2005 Jun 14).
62. Adelman B, Sandrock A, Panzara MA. Natalizumab and progressive multifocal leukoencephalopathy (letter). N Engl J Med 2005;353:432-3. Epub 2005 Jun 9.
63. Armstrong D. New research bolsters tarnished MS drug. Wall Street Journal. April 13, 2005:D1, D5.