Natalizumab: A new treatment for relapsing remitting multiple sclerosis

Therapeutics and Clinical Risk Management

Volumn 3, Issue 2, 2007, Pages 259-268

  Hutchinson, Michael ^a  

^a ST VINCENT S UNIVERSITY HOSPITAL   (Ireland)

Author keywords

4 integrin antagonist; Disease modifying therapy; Multiple sclerosis; Natalizumab; Selective adhesion molecule (SAM) inhibitor; Tysabri

Indexed keywords

ANTIHISTAMINIC AGENT; BETA1A INTERFERON; CORTICOSTEROID; GLATIRAMER; MONOCLONAL ANTIBODY; NATALIZUMAB; PLACEBO; VERY LATE ACTIVATION ANTIGEN 4;

ANTIBODY PRODUCTION; ANXIETY; BRONCHOSPASM; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DISABILITY; DISEASE ACTIVITY; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG MECHANISM; FATIGUE; HUMAN; INFECTION; MONOTHERAPY; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; PERIPHERAL EDEMA; PHARYNGITIS; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; REVIEW; RISK BENEFIT ANALYSIS; RISK REDUCTION; SERUM SICKNESS; SIDE EFFECT; SINGLE DRUG DOSE; SINUS CONGESTION; URTICARIA;

EID: 34249980330     PISSN: 11766336     EISSN: None     Source Type: Journal    
DOI: 10.2147/tcrm.2007.3.2.259     Document Type: Review

References (45)

1. Aharoni R, Teitelbaum O, Leitner O, et al. 2000. Specific Th2 cells accumulate in the central nervous system of mice protected against experimental autoimmune encephalomyelitis by copolymer 1. Proc Natl Acad Sci U S A, 97:11472-7.
2. Avasarala JR, Cross AH, Clifford DB, et al. 2003. Rapid onset mitoxantrone-induced cardiotoxicity in secondary progressive multiple sclerosis. Mult Scler, 9:59-62.
3. 1 integrin. J Cell Sci, 111: 1165-74.
4. Bennett D, Ludden T, Shah J, et al. 2002. The use of pharmacokinetic (PK) modeling and efficacy data to establish optimal dosing of natalizumab (Antegren™) [Abstract]. Mult Scler, 8(suppl 1):s61; P130.
5. Burkly LC, Jakubowski A, Newman BM, et al. 1991. Signaling by vascular cell adhesion molecule-1 (VCAM-1) through VLA-4 promotes CD3-dependent T-cell proliferation. Eur J Immunol, 21:2871-5.
6. Calabresi P, Giovannoni G, Confavreux C, et al. 2007. Incidence and clinical significance of antibodies during treatment with natalizumab: 2 year results from AFFIRM and SENTINEL. Neurology, in press.
7. Carlos TM, Schwartz BR, Kovach NL, et al. 1990. Vascular cell adhesion molecule-1 mediates lymphocyte adherence to cytokine-activated cultured human endothelial cells. Blood, 76:965-70.
8. Clark W, Mucklow J. 1998. Gathering and weighing the evidence. In Panton R, Chapman S, eds. Medicines management. London: BMJ Books and Pharmaceutical, Pr., pp 59-74.
9. Cohen BA, Mikol DO. 2004. Mitoxantrone treatment of multiple sclerosis: safety considerations. Neurology, 63(12 suppl 6):S28-32.
10. Dalton CM, Miszkiel KA, Barker GJ, et al. 2004. Effect of natalizumab on conversion of gadolinium enhancing lesions to T1 hypointense lesions in relapsing multiple sclerosis. J Neurol, 251:407-13.
11. + T lymphocytes. Proc Natl Acad Sci U S A, 88:6403-7.
12. Elices MJ, Osborn L, Takada Y, et al. 1990. VCAM-1 on activated endothelium interacts with the leukocyte integrin VLA-4 at a site distinct from the VLA-4/fibronectin binding site. Cell, 60:577-84.
13. Filippini G, Munari L, Incorvaia B, et al. 2003. Interferons in relapsing remitting multiple sclerosis: a systematic review. Lancet, 361:545-52.
14. Galetta SL, Markowitz C, Lee AG. 2002. Immunomodulatory agents for the treatment of relapsing multiple sclerosis. Arch Intern Med, 162:2161-9.
15. Ghalie RG, Edan G, Laurent M, et al. 2002. Cardiac adverse effects associated with mitoxantrone (Novantrone) therapy in patients with MS. Neurology, 59:909-13.
16. Goodman AD, Rossman HS, Bar-Or A, et al. 2005. GLANCE: a double-blind, randomized, placebo-controlled, parallel-group safety study of natalizumab in combination with glatiramer acetate in subjects with relapsing-remitting multiple sclerosis. Program and abstracts of the American Academy of Neurology 57th Annual Meeting; April 9-16, 2005; Miami Beach, Florida. Abstract S36.003.
17. [IFNB] IFNB Multiple Sclerosis Study Group. 1993. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology, 43:655-61.
18. Jacobs LD, Cookfair DL, Rudick RA, et al. 1996. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol, 39:285-94.
19. Johnson KP, Brooks BR, Cohen JA, et al. 1995. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology, 45:1268-76.
20. Kleinschmidt-DeMasters BK, Tyler KL. 2005. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med, 353:369-74.
21. Langer-Gould A, Atlas SW, Bollen AW, et al. 2005. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med, 353:1-7.
22. Léger OJP, Yednock TA, Tanner L, et al. 1997. Humanization of a mouse antibody against human alpha-4 integrin: a potential therapeutic for the treatment of multiple sclerosis. Hum Antibodies, 8:3-16.
23. Lobb RR, Hemler ME. 1994. The pathophysiologic role of α4 integrins in vivo. J Clin Invest, 94:1722-8.
24. Miller DH, Khan OA, Sheremata WA, et al. 2003. A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med, 348:15-23.
25. [MSIF] Multiple Sclerosis International Federation. 2006. Introduction [online]. Accessed 9 August 2006. URL: http://www.msif.org/en/ ms_the÷sease/.
26. Munari L, Lovati R, Boiko A. 2003. Therapy with glatiramer acetate for multiple sclerosis. Cochrane Database of Syst Rev, 4:CD004678.
27. [NMSS] National Multiple Sclerosis Society. 2006. Research fact sheet [online]. Accessed 9 August 2006. URL: http://www.nationalmssociety.org/ pdf/research/ResearchFactSheet.pdf.
28. Niino M, Bodner C, Simard M-L, et al. 2006. Natalizumab effects on immune cell responses in multiple sclerosis. Ann Neurol, 59:748-54.
29. O'Connor PW, Goodman A, Kappos L, et al. 2006. The safety and tolerability of natalizumab: results from the safety-extension study in patients with multiple sclerosis. Poster presented at: 58th Annual Meeting of the American Academy of Neurology; April 1-8, 2006; San Diego, California.
30. O'Connor PW, Goodman A, Willmer-Hulme AJ, et al. 2004. Randomized multicenter trial of natalizumab in acute MS relapses. Clinical and MRI effects. Neurology, 62:2038-43.
31. Osborn L, Hession C, Tizard R, et al. 1989. Direct expression cloning of vascular cell adhesion molecule 1, a cytokine-induced endothelial protein that binds to lymphocytes. Cell, 59:1203-11.
32. Polman CH, O'Connor PW, Havrdova E, et al. 2006. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med, 354:899-910.
33. [PRISMS] Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis Study Group. 1998. Randomised double-blind placebo-controlled study of interferon β-1a in relapsing/ remitting multiple sclerosis. Lancet, 352:1498-504.
34. [PRISMS] Prevention of Relapses and Disability by Interferon-β-1a Subcutaneously in Multiple Sclerosis Study Group, University of British Columbia MS/MRI Analysis Group. 2001. PRISMS-4: long-term efficacy of interferon-β-1a in relapsing MS. Neurology, 56:1628-36.
35. Rice G PA, Incorvaia B, Munari L, et al. 2001. Interferon in relapsing-remitting multiple sclerosis. Cochrane Database Syst Rev, 4: CD002002.
36. Rudick RA, Hutchinson M, O'Connor P, et al. 2006. Natalizumab improves health-related quality of life in patients with relapsing multiple sclerosis. Neurology, 66(suppl 2):A381-2.
37. 4-integrin antagonist selective adhesion molecule inhibitors for MS. Expert Rev Neurotherapeutics, 4:571-80.
38. Rudick RA, Stuart WH, Calabresi PA, et al. 2006. A randomized, placebo-controlled trial of natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med, 354:911-23.
39. Sheremata WA, Vollmer TL, Stone LA, et al. 1999. A safety and pharmacokinetic study of intravenous natalizumab in patients with MS. Neurology, 52:1072-4.
40. Tubridy N, Behan PO, Capildeo R, et al. 1999. The effect of anti-α4 integrin antibody on brain lesion activity in MS. Neurology, 53:466-72.
41. [Tysabri PI] Biogen Idec, Inc. 2006. Tysabri® (natalizumab) package insert. Cambridge, MA: Biogen Idec, Inc.
42. Van Assche G, Van Ranst M, Sciot R, et al. 2006. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N Engl J Med, 353:362-8.
43. Vollmer TL, Phillips JT, Goodman AD, et al. 2004. An open-label safety and drug interaction study of natalizumab (Antegren™) in combination with interferon-beta (Avonex®) in patients with multiple sclerosis. Mult Scler , 10:511-20.
44. Ware JE, Sherbourne CD. 1992. The MOS 36-item Short-Form Health Survey (SF-36). Conceptual framework and item selection. Med Care, 6:473-83.
45. Yousry TA, Major E, Ryschkewitsch C, et al. 2006 Evaluation for progressive multifocal leukoencephalopathy in natalizumab treated patients. N Engl J Med, 354:924-33.