Neurological Sciences

, 30:163

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

  • G. Tedeschi
  • M. P. Amato
  • R. D’Alessandro
  • F. Drago
  • C. Milanese
  • P. Popoli
  • P. Rossi
  • G. Savettieri
  • M. R. Tola
  • N. Vanacore
  • A. Covezzoli
  • M. De Rosa
  • G. Comi
  • Carlo Pozzilli
  • Antonio Bertolotto
  • Maria Giovanna Marrosu
  • Luigi M. E. Grimaldi
  • C. Piccinni
  • N. Montanaro
  • Laura Periotto
  • Rosamaria Iommelli
  • Antonio Addis
  • Nello Martini
  • L. Provinciali
  • G. L. Mancardi
MS Treatment

DOI: 10.1007/s10072-009-0143-6

Cite this article as:
Tedeschi, G., Amato, M.P., D’Alessandro, R. et al. Neurol Sci (2009) 30: 163. doi:10.1007/s10072-009-0143-6

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.

Keywords

Multiple sclerosisNatalizumabSurveillance programPharmacovigilance

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • G. Tedeschi
    • 1
    • 2
  • M. P. Amato
    • 2
  • R. D’Alessandro
    • 2
  • F. Drago
    • 2
  • C. Milanese
    • 2
  • P. Popoli
    • 2
  • P. Rossi
    • 2
  • G. Savettieri
    • 2
  • M. R. Tola
    • 2
  • N. Vanacore
    • 2
  • A. Covezzoli
    • 3
  • M. De Rosa
    • 3
  • G. Comi
    • 5
  • Carlo Pozzilli
    • 6
  • Antonio Bertolotto
    • 7
  • Maria Giovanna Marrosu
    • 8
  • Luigi M. E. Grimaldi
    • 9
  • C. Piccinni
    • 4
  • N. Montanaro
    • 4
  • Laura Periotto
    • 2
  • Rosamaria Iommelli
    • 2
  • Antonio Addis
    • 2
  • Nello Martini
    • 2
  • L. Provinciali
    • 2
  • G. L. Mancardi
    • 2
  1. 1.Dipartimento di Scienze NeurologicheSeconda Università di Napoli e Istituto Hermitage CapodimonteNaplesItaly
  2. 2.Tavolo Neurologico AIFARomeItaly
  3. 3.Cineca-Consorzio InteruniversitarioBolognaItaly
  4. 4.Centro Regionale di Valutazione e Informazione sui Farmaci (CReVIF)Università di BolognaBolognaItaly
  5. 5.Dipartimento di NeurologiaIstituto Scientifico San RaffaeleMilanItaly
  6. 6.Ospedale S. Andrea, Università La SapienzaRomeItaly
  7. 7.Centro di Riferimento Regionale Sclerosi Multipla, AOU S.Luigi GonzagaTurinItaly
  8. 8.Centro Sclerosi MultiplaUniversità di CagliariCagliariItaly
  9. 9.UO di Neurologia, Fondazione Istituto San Raffaele, G.GiglioPalermoItaly