title: The pharmacovigilance program on natalizumab in Italy: 2 years of experience.
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.
authors.affiliation: Dipartimento di Scienze Neurologiche, Seconda Università di Napoli e Istituto Hermitage Capodimonte, Naples, Italy. gioacchino.tedeschi@unina2.it
authors.forename: G
authors.initials: G
authors.lastname: Tedeschi
authors.forename: M P
authors.initials: MP
authors.lastname: Amato
authors.forename: R
authors.initials: R
authors.lastname: D'Alessandro
authors.forename: F
authors.initials: F
authors.lastname: Drago
authors.forename: C
authors.initials: C
authors.lastname: Milanese
authors.forename: P
authors.initials: P
authors.lastname: Popoli
authors.forename: P
authors.initials: P
authors.lastname: Rossi
authors.forename: G
authors.initials: G
authors.lastname: Savettieri
authors.forename: M R
authors.initials: MR
authors.lastname: Tola
authors.forename: N
authors.initials: N
authors.lastname: Vanacore
authors.forename: A
authors.initials: A
authors.lastname: Covezzoli
authors.forename: M
authors.initials: M
authors.lastname: De Rosa
authors.forename: G
authors.initials: G
authors.lastname: Comi
authors.forename: Carlo
authors.initials: C
authors.lastname: Pozzilli
authors.forename: Antonio
authors.initials: A
authors.lastname: Bertolotto
authors.forename: Maria Giovanna
authors.initials: MG
authors.lastname: Marrosu
authors.forename: Luigi M E
authors.initials: LM
authors.lastname: Grimaldi
authors.forename: C
authors.initials: C
authors.lastname: Piccinni
authors.forename: N
authors.initials: N
authors.lastname: Montanaro
authors.forename: Laura
authors.initials: L
authors.lastname: Periotto
authors.forename: Rosamaria
authors.initials: R
authors.lastname: Iommelli
authors.forename: Antonio
authors.initials: A
authors.lastname: Addis
authors.forename: Nello
authors.initials: N
authors.lastname: Martini
authors.forename: L
authors.initials: L
authors.lastname: Provinciali
authors.forename: G L
authors.initials: GL
authors.lastname: Mancardi
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D016208:Databases, Factual; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D008279:Magnetic Resonance Imaging; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy*; D000069442:Natalizumab; D010352:Patient Dropouts; D011358:Product Surveillance, Postmarketing
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab