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dc.contributor.authorHutchinson, Michael
dc.contributor.authorKappos, Ludwig
dc.contributor.authorCalabresi, Peter A
dc.contributor.authorConfavreux, Christian
dc.contributor.authorGiovannoni, Gavin
dc.contributor.authorGaletta, Steven L
dc.contributor.authorHavrdova, Eva
dc.contributor.authorLublin, Fred D
dc.contributor.authorMiller, David H
dc.contributor.authorO'Connor, Paul W
dc.contributor.authorPhillips, J Theodore
dc.contributor.authorPolman, Chris H
dc.contributor.authorRadue, Ernst-Wilhelm
dc.contributor.authorRudick, Richard A
dc.contributor.authorStuart, William H
dc.contributor.authorWajgt, Andrzej
dc.contributor.authorWeinstock-Guttman, Bianca
dc.contributor.authorWynn, Daniel R
dc.contributor.authorLynn, Frances
dc.contributor.authorPanzara, Michael A
dc.date.accessioned2012-02-01T10:31:51Z
dc.date.available2012-02-01T10:31:51Z
dc.date.issued2012-02-01T10:31:51Z
dc.identifier.citationJ Neurol. 2009 Mar;256(3):405-15. Epub 2009 Mar 18.en_GB
dc.identifier.issn1432-1459 (Electronic)en_GB
dc.identifier.issn0340-5354 (Linking)en_GB
dc.identifier.pmid19308305en_GB
dc.identifier.doi10.1007/s00415-009-0093-1en_GB
dc.identifier.urihttp://hdl.handle.net/10147/207577
dc.description.abstractThe AFFIRM and SENTINEL studies showed that natalizumab was effective both as monotherapy and in combination with interferon beta (IFNbeta)-1a in patients with relapsing multiple sclerosis (MS). Further analyses of AFFIRM and SENTINEL data were conducted to determine the efficacy of natalizumab in prespecified patient subgroups according to baseline characteristics: relapse history 1 year before randomization (1, 2, > or = 3), Expanded Disability Status Scale score (< or = 3.5, > 3.5), number of T2 lesions (< 9, > or = 9), presence of gadolinium-enhancing (Gd+) lesions (0, > or = 1), age (< 40, > or = 40) and gender (male, female). A post hoc analysis was conducted to determine the efficacy of natalizumab in patients with highly active disease (i. e., > or = 2 relapses in the year before study entry and > or = 1 Gd+ lesion at study entry). In both AFFIRM and SENTINEL studies natalizumab reduced the annualized relapse rates across all subgroups (except the small subgroups with < 9 baseline T2 lesions) over 2 years. In AFFIRM, natalizumab significantly reduced the risk of sustained disability progression in most subgroups. In SENTINEL, natalizumab significantly reduced the risk of sustained disability progression in the following subgroups: > or = 9 T2 lesions at baseline, > or = 1 Gd+ lesions at baseline, female patients and patients < 40 years of age. Natalizumab reduced the risk of disability progression by 64 % and relapse rate by 81 % in treatment- naive patients with highly active disease and by 58 % and 76 %, respectively, in patients with highly active disease despite IFNbeta-1a treatment. These results indicate that natalizumab is effective in reducing disability progression and relapses in patients with relapsing MS, particularly in patients with highly active disease.
dc.language.isoengen_GB
dc.subject.meshAdolescenten_GB
dc.subject.meshAdulten_GB
dc.subject.meshAntibodies, Monoclonal/*therapeutic useen_GB
dc.subject.meshAntibodies, Monoclonal, Humanizeden_GB
dc.subject.meshDisease Progressionen_GB
dc.subject.meshFemaleen_GB
dc.subject.meshGadoliniumen_GB
dc.subject.meshHumansen_GB
dc.subject.meshImmunologic Factors/*therapeutic useen_GB
dc.subject.meshInterferon-beta/therapeutic useen_GB
dc.subject.meshKaplan-Meier Estimateen_GB
dc.subject.meshMaleen_GB
dc.subject.meshMiddle Ageden_GB
dc.subject.meshMultiple Sclerosis, Relapsing-Remitting/*drug therapy/pathology/physiopathologyen_GB
dc.subject.meshProportional Hazards Modelsen_GB
dc.subject.meshRecurrenceen_GB
dc.subject.meshSeverity of Illness Indexen_GB
dc.subject.meshTreatment Outcomeen_GB
dc.subject.meshYoung Adulten_GB
dc.titleThe efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL.en_GB
dc.contributor.departmentDept. of Neurology, St. Vincent's University Hospital, Dublin, Ireland., mhutchin@iol.ieen_GB
dc.identifier.journalJournal of neurologyen_GB
dc.description.provinceLeinster
html.description.abstractThe AFFIRM and SENTINEL studies showed that natalizumab was effective both as monotherapy and in combination with interferon beta (IFNbeta)-1a in patients with relapsing multiple sclerosis (MS). Further analyses of AFFIRM and SENTINEL data were conducted to determine the efficacy of natalizumab in prespecified patient subgroups according to baseline characteristics: relapse history 1 year before randomization (1, 2, > or = 3), Expanded Disability Status Scale score (< or = 3.5, > 3.5), number of T2 lesions (< 9, > or = 9), presence of gadolinium-enhancing (Gd+) lesions (0, > or = 1), age (< 40, > or = 40) and gender (male, female). A post hoc analysis was conducted to determine the efficacy of natalizumab in patients with highly active disease (i. e., > or = 2 relapses in the year before study entry and > or = 1 Gd+ lesion at study entry). In both AFFIRM and SENTINEL studies natalizumab reduced the annualized relapse rates across all subgroups (except the small subgroups with < 9 baseline T2 lesions) over 2 years. In AFFIRM, natalizumab significantly reduced the risk of sustained disability progression in most subgroups. In SENTINEL, natalizumab significantly reduced the risk of sustained disability progression in the following subgroups: > or = 9 T2 lesions at baseline, > or = 1 Gd+ lesions at baseline, female patients and patients < 40 years of age. Natalizumab reduced the risk of disability progression by 64 % and relapse rate by 81 % in treatment- naive patients with highly active disease and by 58 % and 76 %, respectively, in patients with highly active disease despite IFNbeta-1a treatment. These results indicate that natalizumab is effective in reducing disability progression and relapses in patients with relapsing MS, particularly in patients with highly active disease.


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