Neurological Sciences

, Volume 29, Supplement 2, pp 235–237 | Cite as

Natalizumab: a country-based surveillance program

  • Gian Luigi Mancardi
  • Maria Pia Amato
  • Roberto D’Alessandro
  • Filippo Drago
  • Clara Milanese
  • Patrizia Popoli
  • Leandro Provinciali
  • Pasqualino Rossi
  • Giovanni Savettieri
  • Gioacchino Tedeschi
  • Maria Rosaria Tola
  • Nicola Vanacore
  • Anna Covezzoli
  • Marisa De Rosa
  • Carlo Piccinni
  • Nicola Montanaro
  • Laura Periotto
  • Antonio Addis
  • Nello Martini
Multiple Sclerosis: The Management of Non-Responders

Abstract

Natalizumab is a humanized monoclonal antibody with a selective adhesion-molecule inhibitor effect, and a demonstrated efficacy in decreasing the frequency of relapses and progression of disability in relapsing-remitting multiple sclerosis (RR MS). After the approval of FDA and EMEA in MS cases unresponsive to immunomodulating therapy or in severe MS patients also not previously treated with interferons, and considering the concern on the possible side effects, an accurate program of surveillance was organized in our country by a combined effort of AIFA, Cineca, Department of Pharmacology of University of Bologna, and a group of neurologists appointed by the National Society of Neurology (SIN). After 15 months from the authorization of natalizumab therapy in MS, as of 31 March 2008, 908 cases have been treated with natalizumab and enrolled in this pharmaco-vigilance study. The mean age is 35 years, while the duration of disease is longer and disability is higher than that reported in the registrative study. Side effects are at the moment mild and similar to those previously described. At follow-up, the majority of treated cases are stable or ameliorated. The treatment was discontinued in 6% of patients.

Keywords

Multiple sclerosis Natalizumab Surveillance program Pharmaco-vigilance 

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Copyright information

© Springer-Verlag Italia 2008

Authors and Affiliations

  • Gian Luigi Mancardi
    • 1
  • Maria Pia Amato
    • 1
  • Roberto D’Alessandro
    • 1
  • Filippo Drago
    • 1
  • Clara Milanese
    • 1
  • Patrizia Popoli
    • 1
  • Leandro Provinciali
    • 1
  • Pasqualino Rossi
    • 1
  • Giovanni Savettieri
    • 1
  • Gioacchino Tedeschi
    • 1
  • Maria Rosaria Tola
    • 1
  • Nicola Vanacore
    • 1
  • Anna Covezzoli
    • 2
  • Marisa De Rosa
    • 2
  • Carlo Piccinni
    • 3
  • Nicola Montanaro
    • 3
  • Laura Periotto
    • 4
  • Antonio Addis
    • 4
  • Nello Martini
    • 4
  1. 1.Tavolo Neurologico AIFARomaItaly
  2. 2.CinecaItaly
  3. 3.Centro Regionale di Valutazione e Informazione sui Farmaci (CReVIF)Università di BolognaBolognaItaly
  4. 4.AIFARomaItaly

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