title: Efficacy and tolerability of natalizumab in relapsing-remitting multiple sclerosis patients: a post-marketing observational study.
abstract: To evaluate the efficacy and safety of natalizumab in patients with active relapsing-remitting multiple sclerosis (MS). We included 285 MS patients receiving natalizumab. Clinical, neuroradiological and safety data were registered every 6 months. Neutralizing antibodies (NABs) were tested after 6 months of treatment. After 1 year, the annualized relapse rate decreased to 0.26, with a significant reduction compared to the previous year (2.13). At 24 months the proportion of "relapse free" patients was 78% while that of "MRI free" patients was 69%. Considering clinical and MRI cumulative activity, "disease free" patients were 63% at 24 months. A total of 18 patients showed NABs positivity. We reported 34 cases of treatment interruptions. In conclusion, our data confirm the remarkable efficacy of natalizumab in a group of patients with higher disease activity than that of pivotal studies.
authors.affiliation: Department of Neurology, INSPE, IRCCS H San Raffaele, via Olgettina 48, 20132, Milan, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Sangalli
authors.forename: L
authors.initials: L
authors.lastname: Moiola
authors.forename: S
authors.initials: S
authors.lastname: Bucello
authors.forename: P
authors.initials: P
authors.lastname: Annovazzi
authors.forename: A
authors.initials: A
authors.lastname: Rizzo
authors.forename: M
authors.initials: M
authors.lastname: Radaelli
authors.forename: G
authors.initials: G
authors.lastname: Vitello
authors.forename: L M E
authors.initials: LM
authors.lastname: Grimaldi
authors.forename: A
authors.initials: A
authors.lastname: Ghezzi
authors.forename: V
authors.initials: V
authors.lastname: Martinelli
authors.forename: G
authors.initials: G
authors.lastname: Comi
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000627:therapeutic use*; D015331:Cohort Studies; D004342:Drug Hypersensitivity / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000503:physiopathology; D000069442:Natalizumab; D011358:Product Surveillance, Postmarketing / Q000639:trends*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab