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01-10-2009 | MS Treatment

Safety profile of Tysabri: international risk management plan

Authors: P. Iaffaldano, M. D’Onghia, Maria Trojano

Published in: Neurological Sciences | Special Issue 2/2009

Abstract

Therapeutic monoclonal antibodies are potent new tools for a molecular targeted approach to modify the course of multiple sclerosis (MS). Natalizumab is a monoclonal antibody targeted against alpha-4 integrin that has proved to be very effective in the treatment of MS. It is well tolerated, although severe side effects have been reported that have conditioned its use as a second-line drug for the treatment of MS. The clinical benefit of natalizumab should be weighed carefully against the potential risk of serious adverse events. Therefore, risk management plans have already been developed in order to prevent or minimise risks relating to natalizumab. Data so far obtained from these observational programs confirm the already demonstrated risk-benefit profile of natalizumab in clinical trials.

Stüve O, Bennett JL (2007) Pharmacological properties, toxicology and scientific rationale for the use of natalizumab (Tysabri) in inflammatory diseases. CNS Drug Rev 13(1):79–95CrossRefPubMed

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 (2006) A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 354:899–910CrossRefPubMed

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 (2006) Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med 354:911–923CrossRefPubMed

Van Assche G, Van Ranst M, Sciot R, Dubois B, Vermeire S, Noman M, Verbeeck J, Geboes K, Robberecht W, Rutgeerts P (2005) Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn’s disease. N Engl J Med 353:362–368CrossRefPubMed

Yousry TA, Major EO, Ryschkewitsch C, Fahle G, Fischer S, Hou J, Curfman B, Miszkiel K, Mueller-Lenke N, Sanchez E, Barkhof F, Radue EW, Jäger HR, Clifford DB (2006) Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med 354:924–933CrossRefPubMed

Bozic C, Belcher G, Kim R, Hyde R, Lynn F, Kooijmans-Coutinho M, Panzara MA (2009) Natalizumab in patients with relapsing multiple sclerosis: updated utilization and safety results including TOUCH™ and TYGRIS. AAN 61st annual meeting Seattle, 2009. Neurology 72(Suppl 3) [S11.005]

Goodman AD, Rossman H, Bar-Or A, Miller A, Miller DH, Schmierer K, Lublin F, Khan O, Bormann NM, Yang M, Panzara MA, Sandrock AW, GLANCE Investigators (2009) GLANCE: results of a phase 2, randomized, double-blind, placebo-controlled study. Neurology 72(9):806–812CrossRefPubMed

O’Connor P, Polman CH, Goodman A, Kappos L, Lublin F, Rudick R, Jurgensen S, Paes D, Lucas N, Panzara MA (2009) Efficacy and safety of natalizumab in the STRATA study. AAN 61st annual meeting Seattle, 2009. Neurology 72(Suppl 3) [P06.127]

Rosenbaum PR, Rubin DB (1983) The central role of the propensity score in observational studies for causal effects. Biometrika 70:41–55CrossRef

10.

Rosenbaum PR, Rubin DB (1984) Reducing bias in observational studies using subclassification on the propensity score. J Am Stat Assoc 79:516–524CrossRef

11.

Trojano M, Pellegrini F, Fuiani A, Paolicelli D, Zipoli V, Zimatore GB et al (2007) New natural history of Interferon-β-treated relapsing Multiple Sclerosis. Ann Neurol 61:300–306CrossRefPubMed

12.

Butzkueven H, Chapman J, Cristiano E, Grand’Maison F, Hoffmann M, Izquierdo G, Jolley D, Kappos L, Leist T, Pöhlau D, Rivera V, Trojano M, Verheul F, Malkowski JP (2006) MSBase: an international, online registry and platform for collaborative outcomes research in multiple sclerosis. Mult Scler 12(6):769–774CrossRefPubMed

13.

Comunicato stampa EMEA. Londra, 25 settembre 2008. Doc. Ref. EMEA/496612/2008

14.

Nota informativa AIFA. Agosto (2008). http://www.agenziafarmaco.it/allegati/nii_tysabri.pdf

15.

http://www.biogenidec.com/site/tysabri-information-center.html

16.

Stüve O, Cravens PD, Frohman EM, Phillips JT, Remington GM, von Geldern G, Cepok S, Singh MP, Cohen Tervaert JW, De Baets M, MacManus D, Miller DH, Radü EW, Cameron EM, Monson NL, Zhang S, Kim R, Hemmer B, Racke MK (2009) Immunologic, clinical, and radiologic status 14 months after cessation of natalizumab therapy. Neurology 72:396–401CrossRefPubMed

Title: Safety profile of Tysabri: international risk management plan
Authors: P. Iaffaldano
M. D’Onghia
Maria Trojano
Publication date: 01-10-2009
Publisher: Springer Milan
Published in: Neurological Sciences / Issue Special Issue 2/2009
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI: https://doi.org/10.1007/s10072-009-0148-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Safety profile of Tysabri: international risk management plan

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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