Document Detail

Efficacy and tolerability of natalizumab in relapsing-remitting multiple sclerosis patients: a post-marketing observational study.
MedLine Citation:
PMID:  20544247     Owner:  NLM     Status:  In-Data-Review    
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.
F Sangalli; L Moiola; S Bucello; P Annovazzi; A Rizzo; M Radaelli; G Vitello; L M E Grimaldi; A Ghezzi; V Martinelli; G Comi
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology     Volume:  31 Suppl 3     ISSN:  1590-3478     ISO Abbreviation:  Neurol. Sci.     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-02-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100959175     Medline TA:  Neurol Sci     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  299-302     Citation Subset:  IM    
Department of Neurology, INSPE, IRCCS H San Raffaele, via Olgettina 48, 20132, Milan, Italy.
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