title: Three years of experience: the Italian registry and safety data update.
abstract: At the end of 2006, a pharmacovigilance program on natalizumab was settled by the Italian Pharmaceutical Agency, and on January 2007, multiple sclerosis patients poorly responding to the immunomodulating therapies or with an aggressive clinical form of disease from onset initiated to be registered and to receive the medication. On February 2010, almost 3,000 cases have been treated with natalizumab. The drop-out rate is 10%. Almost 800 cases received cycles of natalizumab for more than 18 months. One case of PML was reported and other adverse events are similar to those described in phase III studies. The majority of cases remained stable, while in 25% of cases, an improvement of disability was documented.
authors.affiliation: Dipartimento di Neuroscienze, Oftalmologia e Genetica, Università degli Studi di Genova, Genova, Italy. glmancardi@neurologia.unige.it
authors.forename: G L
authors.initials: GL
authors.lastname: Mancardi
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: G
authors.initials: G
authors.lastname: Comi
authors.forename: C
authors.initials: C
authors.lastname: Pozzilli
authors.forename: A
authors.initials: A
authors.lastname: Bertolotto
authors.forename: M G
authors.initials: MG
authors.lastname: Marrosu
authors.forename: L M E
authors.initials: LM
authors.lastname: Grimaldi
authors.forename: A
authors.initials: A
authors.lastname: Laroni
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: C
authors.initials: C
authors.lastname: Piccinni
authors.forename: N
authors.initials: N
authors.lastname: Montanaro
authors.forename: L
authors.initials: L
authors.lastname: Periotto
authors.forename: R
authors.initials: R
authors.lastname: Iommelli
authors.forename: C
authors.initials: C
authors.lastname: Tomino
authors.forename: L
authors.initials: L
authors.lastname: Provinciali
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology; D000069442:Natalizumab; D011358:Product Surveillance, Postmarketing / Q000639:trends*; D012042:Registries / Q000706:statistics & numerical data
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab