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The pharmacovigilance program on natalizumab in Italy: 2 years of experience

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Abstract

At the end of 2006 a country-based surveillance program on natalizumab therapy in multiple sclerosis was settled in Italy by a collaborative effort of the Italian Drug Agency (AIFA) and a group of experts and neurologists appointed by the National Society of Neurology (SIN). After 2 years, 1,818 patients are registered in the database. The majority of cases (88.6%) failed the therapy with beta interferon or glatiramer acetate and had relapses or accumulated disability during immunomodulating treatment, while 11.4% of patients enrolled in the surveillance study were not previously treated with immunomodulating therapies and had a rapidly evolving clinical course. Almost 10% of the patients treated with natalizumab interrupted, for various different reasons, the therapy. Treatment was well tolerated and side effects were similar to those reported in the registrative studies. The majority of treated cases are stable or ameliorated.

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Conflict of interest statement

The authors declare that they have no conflict of interest related to the publication of this manuscript.

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Authors and Affiliations

  1. Dipartimento di Scienze Neurologiche, Seconda Università di Napoli e Istituto Hermitage Capodimonte, Naples, Italy

    G. Tedeschi

  2. Tavolo Neurologico AIFA, Rome, Italy

    G. Tedeschi, M. P. Amato, R. D’Alessandro, F. Drago, C. Milanese, P. Popoli, P. Rossi, G. Savettieri, M. R. Tola, N. Vanacore, Laura Periotto, Rosamaria Iommelli, Antonio Addis, Nello Martini, L. Provinciali & G. L. Mancardi

  3. Cineca-Consorzio Interuniversitario, Bologna, Italy

    A. Covezzoli & M. De Rosa

  4. Centro Regionale di Valutazione e Informazione sui Farmaci (CReVIF), Università di Bologna, Bologna, Italy

    C. Piccinni & N. Montanaro

  5. Dipartimento di Neurologia, Istituto Scientifico San Raffaele, Milan, Italy

    G. Comi

  6. Ospedale S. Andrea, Università La Sapienza, Rome, Italy

    Carlo Pozzilli

  7. Centro di Riferimento Regionale Sclerosi Multipla, AOU S.Luigi Gonzaga, Orbassano, Turin, Italy

    Antonio Bertolotto

  8. Centro Sclerosi Multipla, Università di Cagliari, Cagliari, Italy

    Maria Giovanna Marrosu

  9. UO di Neurologia, Fondazione Istituto San Raffaele, G.Giglio, Cefalù, Palermo, Italy

    Luigi M. E. Grimaldi

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  1. G. Tedeschi
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  2. M. P. Amato
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  3. R. D’Alessandro
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  4. F. Drago
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  5. C. Milanese
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  6. P. Popoli
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  7. P. Rossi
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  8. G. Savettieri
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  9. M. R. Tola
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  10. N. Vanacore
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  11. A. Covezzoli
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  12. M. De Rosa
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  13. G. Comi
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  14. Carlo Pozzilli
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  15. Antonio Bertolotto
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  16. Maria Giovanna Marrosu
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  17. Luigi M. E. Grimaldi
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  18. C. Piccinni
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  19. N. Montanaro
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  20. Laura Periotto
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  21. Rosamaria Iommelli
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  22. Antonio Addis
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  23. Nello Martini
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  24. L. Provinciali
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  25. G. L. Mancardi
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Corresponding author

Correspondence to G. Tedeschi.

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Tedeschi, G., Amato, M.P., D’Alessandro, R. et al. The pharmacovigilance program on natalizumab in Italy: 2 years of experience. Neurol Sci 30 (Suppl 2), 163–165 (2009). https://doi.org/10.1007/s10072-009-0143-6

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  • DOI: https://doi.org/10.1007/s10072-009-0143-6

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