title: Natalizumab: a country-based surveillance program.
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.
authors.affiliation: Tavolo Neurologico AIFA. glmancardi@neurologia.unige.it
authors.forename: Gian Luigi
authors.initials: GL
authors.lastname: Mancardi
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Amato
authors.forename: Roberto
authors.initials: R
authors.lastname: D'Alessandro
authors.forename: Filippo
authors.initials: F
authors.lastname: Drago
authors.forename: Clara
authors.initials: C
authors.lastname: Milanese
authors.forename: Patrizia
authors.initials: P
authors.lastname: Popoli
authors.forename: Leandro
authors.initials: L
authors.lastname: Provinciali
authors.forename: Pasqualino
authors.initials: P
authors.lastname: Rossi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Savettieri
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Tedeschi
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Tola
authors.forename: Nicola
authors.initials: N
authors.lastname: Vanacore
authors.forename: Anna
authors.initials: A
authors.lastname: Covezzoli
authors.forename: Marisa
authors.initials: M
authors.lastname: De Rosa
authors.forename: Carlo
authors.initials: C
authors.lastname: Piccinni
authors.forename: Nicola
authors.initials: N
authors.lastname: Montanaro
authors.forename: Laura
authors.initials: L
authors.lastname: Periotto
authors.forename: Antonio
authors.initials: A
authors.lastname: Addis
authors.forename: Nello
authors.initials: N
authors.lastname: Martini
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D004351:Drug Resistance / Q000187:drug effects / Q000276:immunology; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D007558:Italy; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000276:immunology; D000069442:Natalizumab; D009313:National Health Programs / Q000592:standards / Q000639:trends; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000639:trends; D011358:Product Surveillance, Postmarketing
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; D000069442:Natalizumab