Neurol. praxi. 2017;18(3):202-206 | DOI: 10.36290/neu.2017.086

TYSABRI – new management of risk factors

MUDr. Yvonne Benešová, Ph.D.
Neurologická klinika LF MU a FN Brno

Natalizumab belongs to monoclonal antibodies. This is a high- efficacy drug, which substantially reduces the activity and leads

to long-term stabilization of multiple sclerosis. However, the therapy is associated with a risk of developing progressive multifocal

leukoencephalopathy (PML) in patients infected with the John Cunningham Virus. Standardized high-quality monitoring

procedures, clinical assessments, magnetic resonance imaging monitoring and use of biomarkers enable risk stratification. Early

detection of disease in asymptomatic stage substantially improves survival and reduce the functional outcomes.

Keywords: natalizumab, monoclonal antibodies, multiple sclerosis, progressive multifocal leukoencephalopathy

Published: July 1, 2017  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
Benešová Y. TYSABRI – new management of risk factors. Neurol. praxi. 2017;18(3):202-206. doi: 10.36290/neu.2017.086.
Download citation

References

  1. Astrom KE, Mancall EL, Richardson EP Jr. Progressive multifocal leukoencephalopathy, a hitherto unrecognized complication of chronic lymphatic leukaemia and Hodgkin's disease. Brain 1958; 81: 93-111. Go to original source... Go to PubMed...
  2. Berenguer J, Miralles P, Arrizabalanga J, Ribera E, Dronda F, Baraia-Etxaburu J, Domingo P, Márquez M, Rodriguez-Arrondo FJ, Laguna F, Rubio R, Lacruz Rodrigo J, Mallolas J, de Miguel V. GESIDA 11/99 Study Group. Clinical course and prognostic factors of progressive multifocal leukoencephalopathy in patients treated with highly active antiretro iral therapy. Clinical Infectious Diseases 2003; 36: 1047-1052. Go to original source... Go to PubMed...
  3. BiogenIdec TOP: Tysabri Observational Program (Data Export Date 01NOV2016).
  4. Bozic C, Richman S, Plavina T, Natarajan A, Scanlon JV, Subramanyam M, Sandrock A, Bloomgren G. Anti-John Cunnigham virus antibody prevalence in multiple sclerosis patients: baseline results of STRATIFY-1. Ann Neurol 2011; 70 (5): 742-750. Go to original source... Go to PubMed...
  5. Brück W. The pathology of multiple sclerosis is the result of focal inflammatory demyelination with axonal damage. J Neurol 2005; 252: v3-v9. Go to original source... Go to PubMed...
  6. Butzkueven H, Kappos L, Pellegrini F, Trojano M, Wiendl H, Patel RN, Zhang A, Hotermans C, Belachew S; TYSABRI Observational Program (TOP) Investigators. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results.J Neurol Neurosurg Psychiatry 2014; 85(11): 1190-1197. Go to original source... Go to PubMed...
  7. Carrillo-Infante C, Richman S, Yu B. Functional and survival outcomes of asymptomatic progressive multifocal leukoencephalopathy in natalizumab-treated multiple sclerosis patients: ECTRIMS 2016; P: 1528. Go to PubMed...
  8. Cinque P, Scarpellini P, Vago L, Linde A, Lazzarin A. Diagnosis of central nervous system complications in HIV-infected patients: cerebrospinal fluid analysis by the polymerase chain reaction. AIDS 1997; 11: 1-17. Go to original source... Go to PubMed...
  9. Dong-Si T, Richman S, Wattjes MP, Wenten M, Gheuens S, Philip J, Datta S, McIninch J, Bozic C, Bloomgren G, Richert N. Outcome and survival of asymptomatic PML in natalizumab-treated MS patients. Ann Clin Transl Neurol 2014; 1(10): 755-764. Go to original source... Go to PubMed...
  10. Dong-Si T, Gheuens S, Gangadharan A, Wenten M, Philip J, McIninch J, Datta S, Richert N, Bozic C, Bloomgren G, Richman S, Weber T, Clifford DB. Predictors of survival and functional outcomes in natalizumab-associated progressive multifocal leukoencephalopathy. J Neurovirol 2015; 21(6): 637-644. Go to original source... Go to PubMed...
  11. Hartung HP, Bar-Or A, Zoukos Y. What do we know about the mechanism of action of disease-modifying treatments in MS? J Neurol 2004; 251: 12-19. Go to original source... Go to PubMed...
  12. Kappos L, Bates D, Edan G, Eraksoy M, Garcia-Merino A, Grigoriadis N, Hartung HP, Havrdová E, Hillert J, Hohlfeld R, Kremenchutzky M, Lyon-Caen O, Miller A, Pozzilli C, Ravnborg M, Saida T, Sindic C, Vass K, Clifford DB, Hauser S, Major EO, O'Connor PW, Weiner HL, Clanet M, Gold R, Hirsch HH, Radü EW, S?rensen PS, King J. Natalizumab treatment for multiple sclerosis: updated recommendations for patient monitoring and selection. Lancet Neurol 2011; 10: 745-758. Go to original source... Go to PubMed...
  13. Kappos L, Butzkueven H, Spelman T, Trojano M, Wiendl H, Chen Y, Ho PR, Koendgen H, Campbell N. Long-term real-world effectiveness of natalizumab: Treatment Outcomes from the TYSARI(R) Observational Program (TOP) stratified by baseline disability. 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis 2016; P 1228.
  14. Kean JM, Rao S, Wang M, Garcea RL. Seroepidemiology of human polyomaviruses. PLoS Pathog 2009; 5(3): e1000363. Go to original source... Go to PubMed...
  15. Koralnik IJ. New insights into progressive multifocal leukoencephalopathy. Curr Opin Neurol 2004; 17: 365-370. Go to original source... Go to PubMed...
  16. Martin R, Bielekova B, Gran B, McFarland HF. Lessons from studies of antigen-specific T cell responses in Multiple Sclerosis. J Neural Transm Suppl. 2000; 60: 361-373. Go to original source... Go to PubMed...
  17. Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006; 354: 899-910. Go to original source... Go to PubMed...
  18. Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006; 354: 911-923. Go to original source... Go to PubMed...
  19. Safak M, Khalili K. An overview: Human polyomavirus JC virus and its associated disorders. J Neurovirol 2003; 9(Suppl. 1): 3-9. Go to original source... Go to PubMed...
  20. Sellebjerg F, Cadavid D, Steiner D, Villar LM, Reynolds R, Mikol D. Exploring potential mechanisms of action of natalizumab in secondary progressive multiple sclerosis. Ther Adv Neurol Disord. 2016; 9(1): 31-43. Go to original source... Go to PubMed...
  21. Shackelton LA, Rambaut A, Pybus OG, Holmes EC. JC virus evolution and its association with human populations J Virol 2006; 80(20): 9928-9933. Go to original source... Go to PubMed...
  22. Schippling S, Kempf C, Büchele F, Jelcic I, Bozinov O, Bont A, Linnebank M, Sospedra M, Weller M, Budka H, Martin R. JC virus granule cell neuronopathy and GCN-IRIS under natalizumab treatment. Ann Neurol. 2013; 74(4): 622-626. Go to original source... Go to PubMed...
  23. Schwab N, Schneider-Hohendorf T, Posevitz V, Breuer J, Göbel K, Windhagen S, Brochet B, Vermersch P, Lebrun-Frenay C, Posevitz-Fejfár A, Capra R, Imberti L, Straeten V, Haas J, Wildemann B, Havla J, Kümpfel T, Meinl I, Niessen K, Goelz S, Kleinschnitz C, Warnke C, Buck D, Gold R, Kieseier BC, Meuth SG, Foley J, Chan A, Brassat D, Wiendl H. L-selectin is a possible biomarker for individual PML risk in natalizumab-treated MS patients. Neurology 2013; 81(10): 865-871. Go to original source... Go to PubMed...
  24. Stuve O, Marra CM, Jerome KR, Cook L, Cravens PD, Cepok S, Frohman EM, Phillips JT, Arendt G, Hem-mer B, Monson NL, Racke MK. Immune surveillance in multiple sclerosis patients treated with natalizumab. Ann Neurol. 2006; 59: 743-47. Go to original source... Go to PubMed...
  25. Štourač P. Imunomodulační léčba roztroušené sklerózy mozkomíšní v klinických a zobrazovacích paramet-rech. Cesk Slov Neurol N 2012; 75: 404-410.
  26. TYSABRI(R) (natalizumab): PML in Patients Receiving TYSABRI (EMA TYSABRI PML Update) - Biogen Medical Information 15 MAR 2017.
  27. Vermersch P, Kappos L, Gold R, Foley JF, Olsson T, Cadavid D, Bozic C, Richman S. Clinical outcomes of natalizumab-associated progressive multifocal leukoencephalopathy. Neurology 2011; 76(20): 1697-1704. Go to original source... Go to PubMed...
  28. Wattjes MP, Richert ND, Killestein J, de Vos M, Sanchez E, Snaebjornsson P, Cadavid D, Barkhof F. The chameleon of neuroinflammation: magnetic resonance imaging characteristics of natalizumab-associated progressive multifocal leukoencephalopathy. Mult Scler 2013; 19: 1826-1840. Go to original source... Go to PubMed...




Neurology for Practice

Madam, Sir,
please be aware that the website on which you intend to enter, not the general public because it contains technical information about medicines, including advertisements relating to medicinal products. This information and communication professionals are solely under §2 of the Act n.40/1995 Coll. Is active persons authorized to prescribe or supply (hereinafter expert).
Take note that if you are not an expert, you run the risk of danger to their health or the health of other persons, if you the obtained information improperly understood or interpreted, and especially advertising which may be part of this site, or whether you used it for self-diagnosis or medical treatment, whether in relation to each other in person or in relation to others.

I declare:

  1. that I have met the above instruction
  2. I'm an expert within the meaning of the Act n.40/1995 Coll. the regulation of advertising, as amended, and I am aware of the risks that would be a person other than the expert input to these sites exhibited


No

Yes

If your statement is not true, please be aware
that brings the risk of danger to their health or the health of others.