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

Hutchinson, Michael and Kappos, Ludwig and Calabresi, Peter A. and Confavreux, Christian and Giovannoni, Gavin and Galetta, Steven L. and Havrdova, Eva and Lublin, Fred D. and Miller, David H. and O'Connor, Paul W. and Phillips, J. Theodore and Polman, Chris H. and Radue, Ernst-Wilhelm and Rudick, Richard A. and Stuart, William H. and Wajgt, Andrzej and Weinstock-Guttman, Bianca and Wynn, Daniel R. and Lynn, Frances and Panzara, Michael A.. (2009) The efficacy of natalizumab in patients with relapsing multiple sclerosis : subgroup analyses of AFFIRM and SENTINEL. Journal of neurology : official journal of the European Neurological Society ... [et al.] = Zeitschrift für Neurologie, Vol. 256. pp. 405-415.

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Official URL: http://edoc.unibas.ch/dok/A6003868

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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.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Neurologie > Neuroimmunologie (Kappos)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Neurologie > Neuroimmunologie (Kappos)
UniBasel Contributors:Kappos, Ludwig
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:Springer
ISSN:0340-5354
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:01 Mar 2013 11:14
Deposited On:01 Mar 2013 11:11

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