Bibliography
- Knigge KL. Inflammatory bowel disease. Clin Cornerstone 2002;4:49-60
- Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, and environmental influences. Gastroenterology 2004;126:1504-17
- Karlinger K, Gyorke T, Mako E, The epidemiology and the pathogenesis of inflammatory bowel disease. Eur J Radiol 2000;35:154-67
- Carter MJ, Lobo AJ, Travis SP. Guidelines for the management of inflammatory bowel disease in adults. Gut 2004;53(suppl 5):V1-16
- Hanauer SB. Turning traditional treatment strategies on their heads: current evidence for “stepup” versus “top-down”. Rev Gastroenterol Disord 2007;7(suppl 2):s17-22
- Hommes D, Baert F, van Assche G, A randomized controlled trial evaluating the ideal medical management for Crohn's Disease (CD): top-down versus step-up strategies. Gastroenterology 2005;128(suppl 2): A-577
- Multiple Sclerosis International Federation. MS – the disease. Quick facts. Available from: http://www.msif.org/en/about_ms/index.html.
- What is multiple sclerosis. National Multiple Sclerosis Society. New York. Available from: http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/ what-is-ms/index.aspx [Last accessed 29 June 2010]
- Leary SM, Porter B, Thompson AJ. Multiple sclerosis: diagnosis and the management of acute relapse. Postgrad Med J 2005;81:302-8
- Compston A, Ebers G, Lassman H, McAlpine's multiple sclerosis. 3rd edition. Churchill Livingstone, London, UK; 1988
- Compston A. Coles A. Multiple sclerosis. Lancet 2002;350:1221-31
- Noseworthy JH, Lucchinetti C, Rodriguez M, Multiple sclerosis. N Engl J Med 2000;343:938-52
- Boster A, Gilles E, Adil J, Intense immunosupression in patients with rapidly worsening multiple sclerosis: treatment guidelines for the clinician. Lancet Neurol 2008;7:173-83
- National Collaborating Centre for Chronic Conditions. Multiple sclerosis. National clinical guideline for diagnosis and management in primary and secondary care. National Institute for Clinical Excellence (NICE), London. UK; 2004
- Elovaara I, Apostolsk S, van doorn P, EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases. Eur J Neurol 2008;15:893-908
- Sellebjerg F, Barnes D, Fillippini G, EFNS guideline on treatment of multiple sclerosis relapses: report of an EFNS task force on treatment of multiple sclerosis relapses. Eur J Neurol 2005;12:939-46
- Assessment: the use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review). Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. National Guideline Clearinghouse; Rockville, MD; 2010. Available from: http://www.guideline.gov/summary/summary.aspx?doc_id=13011& nbr=6705&ss=6&xl=999. [Last accessed 29 June 2010]
- Vajkoczy P, Laschinger M, Engelhardt B. Alpha4-integrin-VCAM-1 binding mediates G protein-independent capture of encephalitogenic T cell blasts to CNS white matter microvessels. J Clin Invest 2001;108:557-65
- Massart C, Gibassier J, Oger J, Neutralizing antibodies to interferon beta in multiple sclerosis: analytical evaluation for validation of a cytopathtic effect assay. Clinica Chimica Acta 2007;377:185-91
- European Public Assessment Report (EPAR) Tysabri. European Medicines Agency, London, UK; 27 June 2006. Available from: http://www.ema. europa.eu/humandocs/PDFs/ EPAR/tysabri/H-603-en1.pdf. [Last accessed 29 June 2010]
- Tysabri (natalizumab) Dossier Crohn's disease, Biogen Idec, Inc. and Elan Pharmaceuticals, Inc., 2008
- Tysabri (natalizumab) Dossier Multiple Sclerosis, Biogen Idec, Inc. and Elan Pharmaceuticals, Inc., 2008
- Tysabri Prescribing Information. Biogen Idec, Inc., Cambridge, MA; 2006. Available from: http://www.biogenidec.com/site/TYSABRI-PI-MedGuide.pdf. [Last accessed 29 June 2010]
- Minagar A, Alexander JS. Blood–brain barrier disruption in multiple sclerosis. Mult Scler 2003;9:540-9
- Carlos TM, Harlan JM. Leukocyte–endothelial adhesion molecules. Blood 1994;84:2068-101
- von Andrian UH, Engelhardt B. Alpha4 integrins as therapeutic targets in autoimmune disease. N Engl J Med 2003;348:68-72
- Frenette PS, Wagner DD. Adhesion molecules: part I. N Engl J Med 1996;334:1526-9
- Frenette PS, Wagner DD. Adhesion molecules: part II: blood vessels and blood cells. N Engl J Med 1996;335:43-5
- Hickey WF, Hsu BL, Kimura H. T-lymphocyte entry into the central nervous system. J Neurosci Res 1991;28:254-60
- Vajkoczy P, Laschinger M, Engelhardt B. Alpha4-integrin-VCAM-1 binding mediates G protein-independent capture of encephalitogenic T cell blasts to CNS white matter microvessels. J Clin Invest 2001;108:557-65
- Rudick RA, Sandrock A. Natalizumab: alpha4-integrin antagonist selective adhesion molecule inhibitors for MS. Expert Rev Neurother 2004;4(4):571-80
- Brudek T, Christensen T, Aagaard L, B cells and monocytes from patients with active multiple sclerosis exhibit increased surface expression of both HERV-H Env and HERV-W Env, accompanied by increased seroreactivity. Retrovirology 2009;6:104
- Sheremata WA, Minagar A, Alexanaer JS, The role of alpha-4 integrin in the etiology of multiple sclerosis: Current knowledge and therapeutic implications. CNS Drugs 2005;19:909-22
- Linda H, von Heijne A, Major EO, Progressive multifocal lekoencephalopathy after natalizumab monotherapy. N Engl J Med 2009;361:1081-7
- The Tysabri TOUCH® Prescribing Program. Biogen Idec, Weston, MA; Available from: http://www.tysabri.com/tysbProject/tysb.portal/_baseurl/threeColLayout/SCSRepository/en_US/tysb/home/treatment-with-tysabri/ touch-prescribing-program.xml. [Last accessed 29 June 2009]
- Annex: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states. European Medicines Agency, London, UK; [22 December 2006]. Available at: http://www.ema.europa.eu/humandocs/PDFs/EPAR/tysabri/H-603-Annex-en.pdf
- Polman CH, O'Connor PW, Havrdova E, A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006;354:899-910
- Rudick RA, Stuart WH, Calabresi PA, Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med 2006;354:911-23
- Targan SR, Feagan BG, Fedorak RN, International Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE) Trial Group. Natalizumab for the treatment of active Crohn's disease: results of the ENCORE Trial. Gastroenterology 2007;132:1672-83
- Sandborn WJ, Colombel JF, Enns R, International Efficacy of Natalizumab as Active Crohn's Therapy (ENACT-1) Trial Group; Evaluation of Natalizumab as Continuous Therapy (ENACT-2) Trial Group. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med 2005;353:1912-25
- Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med 2005;353:369-74
- Yousry TA, Major EO, Ryschkewitsch C, Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med 2006;354:924-33
- Conway D, Cohen JA. Combination therapy in multiple sclerosis. Lancet Neurol 2010;9:299-308
- Goodman AD, Rossman H, Bar-OR A, GLANCE: results of a phase 2, randomized, double-blind, placebo-controlled study. Neurology 2009;72:806-12
- Brain disease virus found in natalizumab treated MS patients. Disabled World, Montreal, Canada; 2009. Available from: http://www.disabled-world.com/health/autoimmunediseases/ms/natalizumab-ms.php. [Last accessed 29 June 2010]
- Langer-Gould A, Atlas SW, Green AJ, Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med 2005;353:375-81
- “News Detail: National MS Society,” Update on Tysabri and PML. Available from: http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=2308. [Accessed 19 August 2009]
- Clifford DB. DeLuca A, Simpson DM, Natalizumab-associated progressive multifocal leukoencephalopahty in patients with multiple sclerosis: lesions from 28 cases. Lancet Neurol 2010;9:438-46
- Jeffery S. New case of PML with natalizumab monotherapy. Medscape, New York, NY; 17 December 2008. Available from: http://www.medscape.com/viewarticle/585512. [Last accessed 29 June 2010]
- Major EO. Reemergence of PML in natalizumab-treated patients-new cases, same concerns. N Engl J Med 2009;36:1041-3
- FDA MedWatch-Tysabri (natalizumab)-two new cases of progressive multifocal leukoencephalopathy in European patients receiving drug as monotherapy for multiple sclerosis for more than one year. Infectious Disease Society of America, Arlington, VA; Available from: http://www.idsociety. org/Content.aspx?id=11872. [Last accessed 29 June 2010]
- New cases of PML found in MS patients taking natalizumab. American Academy of Neurology, Saint Paul, MN; 2008. Available from: http://www.aan.com/news/?event=read&article_id=5753. [Last accessed 29 June 2010]
- Talan J. Two more patients on natalizumab develop PML. Neurol Today 2008;8:19
- FDA Continues to Receive Reports of PML in Patients Receiving Natalizumab. US Food and Drug Administration, Rockville, MD; 2009. Available from: http://www.docguide.com/news/content.nsf/news/852576140048867A85257639006795F6. [Last accessed 29 June 2010]
- Food and Drug Administration. FDA Drug Safety communication: risk of progressive multifocal leukoencephalopathy (PML) with the use of Tysabri (natalizumab). US Food and Drug Administration, Rockville, MD; Updated 2/5/2010. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm199872.htm. [Last accessed 29 June 2010]
- Pocock N. FDA Medwatch: risk of PML with natalizumab increases with number of infusions. US Food and Drug Administration, Rockville, MD; 2009. Available from: http://www. nelm-web.lbi.co.uk/en/NeLM-Area/News/2010- - -February/08/ FDA-Medwatch-Risk-of-PML-with-natalizumab-increases-with-number-of-infusions/ [Last accessed 29 June 2010]
- Anderson P. AAN 2009: Incidence of PML with natalizumab in MS lower than previously thought. Medscape, New York, NY; 2009. Available from: http://www.medscape.com/viewarticle/702373. [Last accessed 29 June 2010]
- Jeffrey S. PML risk increases with repeated Natalizumab infusions: FDA. Medscape, New York, NY; 2010. Available from: http://www.medscape.com/viewarticle/716536. [Last accessed 29 June 2010]
- FDA warns of link between natalizumab, brain infection risk of PML increases as number of infusions received increases. Modern Medicine, Woodland Hills, CA; 2010. Available from: http://www.modernmedicine.com/modernmedicine/Modern+Medicine+Now/FDA-Warns-of-Link-Between-Natalizumab-Brain-Infect/ArticleNewsFeed/Article/detail/655741. [Last accessed 29 June 2010]
- Jeffery S. Asymptomatic reactivation of JC virus found in natalizumab-treated MS patients; PML case reports released. Medscape, New York, NY; 2009. Available from: http://www.medscape.com/viewarticle/708701. [Last accessed 29 June 2010]
- Lonergan RM, Carr MJ, Gascun C, Reactivation of BK polyomavirus in patients with multiple sclerosis receiving natalizumab therapy. J Neurovirol 2009;15:351-9
- Jilek S, Jaquiery E, Hirsch HH, Immune responses to JC virus in patients with multiple sclerosis treated with natalizumab: a cross-sectional and longitudinal study. Lancet Neurol 2010:9:264-272
- FDA to amend natalizumab label based on new cases of PML in Europe. US Food and Drug Administration, Rockville, MD; 2008. Available from: http://www.docguide.com/news/content.nsf/ news/852571020057CCF6852574 B0007050D9. [Last accessed 29 June 2010]
- Ranshoff RM. PML risk and natalizumab: more questions than answers. Lancet Neurol 2010;9:231-3
- Koralink IJ. Progressive multifocal leukoencephalopathy revisted: has the disease outgrown its name? Ann Neurol 2006;60:162-73
- Calabrese LH, Mollow ES, Huang D, Ranshoff RM. Progressive multifocal pathologic patterns of disease. Arthritis Preum 2007;56:2116-28
- Information on Natalizumab. US Food and Drug Administration, Rockville, MD; 2009. Available from: http://www.fda. gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm107198.htm. [Last accessed 29 June 2010]
- EMEA recommends update of product information of natalizumab and risk of progressive multifocal leukoencephalopathy (PML). European Medicines Agency, London, UK; 2008. Available from: http://www.ema.europa.eu/humandocs/PDFs/EPAR/tysabri/49661208en.pdf. [Last accessed 29 June 2010]
- Tysabri (natalizumab) Marketing Suspended. US Food and Drug Administration, Rockville, MD; 2005. Available from: http://www.medicinenet.com/script/main/art. asp?articlekey=47298. [Last accessed 29 June 2010]
- US FDA issues alert to healthcare professionals regarding natalizumab and progressive multifocal leukoencephalopathy. US Food and Drug Administration, Rockville, MD; 2008. Available from: http://www. nelm.nhs.uk/en/NeLM-Area/News/2008---August/26/US-FDA-issues- alert-to-healthcare-professionals-regarding-natalizumab-and-progressive-multifocal-leukoencephalopathy/ [Last accessed 29 June 2010]
- Hanauer SB, Feagan BG, Lichtenstein GR, Maintenance infliximab for Crohn's disease: the ACCENT I randomized trial. Lancet 2002;359:1541-9
- Colombel JF, Sandborn WJ, Rutgeerts P, Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterolgy 2007;132:52-65
- Tysabri Prescribing Information, Biogen Idec, Inc., 2008. [Update] Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s0067lbl.pdf