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    The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL.

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    Authors
    Hutchinson, Michael
    Kappos, Ludwig
    Calabresi, Peter A
    Confavreux, Christian
    Giovannoni, Gavin
    Galetta, Steven L
    Havrdova, Eva
    Lublin, Fred D
    Miller, David H
    O'Connor, Paul W
    Phillips, J Theodore
    Polman, Chris H
    Radue, Ernst-Wilhelm
    Rudick, Richard A
    Stuart, William H
    Wajgt, Andrzej
    Weinstock-Guttman, Bianca
    Wynn, Daniel R
    Lynn, Frances
    Panzara, Michael A
    Show allShow less
    Affiliation
    Dept. of Neurology, St. Vincent's University Hospital, Dublin, Ireland., mhutchin@iol.ie
    Issue Date
    2012-02-01T10:31:51Z
    MeSH
    Adolescent
    Adult
    Antibodies, Monoclonal/*therapeutic use
    Antibodies, Monoclonal, Humanized
    Disease Progression
    Female
    Gadolinium
    Humans
    Immunologic Factors/*therapeutic use
    Interferon-beta/therapeutic use
    Kaplan-Meier Estimate
    Male
    Middle Aged
    Multiple Sclerosis, Relapsing-Remitting/*drug therapy/pathology/physiopathology
    Proportional Hazards Models
    Recurrence
    Severity of Illness Index
    Treatment Outcome
    Young Adult
    Show allShow less
    
    Metadata
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    Citation
    J Neurol. 2009 Mar;256(3):405-15. Epub 2009 Mar 18.
    Journal
    Journal of neurology
    URI
    http://hdl.handle.net/10147/207577
    DOI
    10.1007/s00415-009-0093-1
    PubMed ID
    19308305
    Abstract
    The 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.
    Language
    eng
    ISSN
    1432-1459 (Electronic)
    0340-5354 (Linking)
    ae974a485f413a2113503eed53cd6c53
    10.1007/s00415-009-0093-1
    Scopus Count
    Collections
    St. Vincent's University Hospital

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