Efficacy of natalizumab in second line therapy of relapsing–remitting multiple sclerosis: results from a multi‐center study in German speaking countries
Identifieur interne : 000B08 ( Istex/Corpus ); précédent : 000B07; suivant : 000B09Efficacy of natalizumab in second line therapy of relapsing–remitting multiple sclerosis: results from a multi‐center study in German speaking countries
Auteurs : N. Putzki ; O. Yaldizli ; M. M Urer ; S. Cursiefen ; S. Kuckert ; C. Klawe ; M. Maschke ; B. Tettenborn ; V. LimmrothSource :
- European Journal of Neurology [ 1351-5101 ] ; 2010-01.
English descriptors
Abstract
Background: Natalizumab has been recommended for the treatment of relapsing–remitting multiple sclerosis (RRMS) in patients with insufficient response to interferon‐beta/glatiramer acetate (DMT) or aggressive MS. The pivotal trials were not conducted to investigate natalizumab monotherapy in this patient population.
Url:
DOI: 10.1111/j.1468-1331.2009.02728.x
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<front><div type="abstract">Background: Natalizumab has been recommended for the treatment of relapsing–remitting multiple sclerosis (RRMS) in patients with insufficient response to interferon‐beta/glatiramer acetate (DMT) or aggressive MS. The pivotal trials were not conducted to investigate natalizumab monotherapy in this patient population.</div>
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<abstract><p>Background: Natalizumab has been recommended for the treatment of relapsing–remitting multiple sclerosis (RRMS) in patients with insufficient response to interferon‐beta/glatiramer acetate (DMT) or aggressive MS. The pivotal trials were not conducted to investigate natalizumab monotherapy in this patient population.</p>
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<abstract><p>Method: Retrospective, multicenter study in Germany and Switzerland. Five major MS centers reported all RRMS patients who initiated natalizumab ≥12 months prior to study conduction.</p>
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<abstract><p>Results: Ninety‐seven RRMS patients were included [69% female, mean age 36.5 years, mean Expanded Disability Status Scale (EDSS) 3.4; 93.8% were pre‐treated with DMT], mean treatment duration with natalizumab was 19.3 ± 6.1 months. We found a reduction of the annualized relapse rate from 2.3 to 0.2, 80.4% were relapse free with natalizumab. EDSS improved in 12.4% and 89.7% were progression free (change of >/= 1 EDSS point). Eighty‐six per cent of patients with highly active disease (>/= 2 relapses in the year and >/= 1 Gadolinium (Gd)+ lesion at study entry, n = 20) remained relapse free. The mean number of Gd enhancing lesions was reduced to 0.1 (0.8 at baseline). Discontinuation rate was 8.2% (4.1% for antibody‐positivity).</p>
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<abstract><p>Conclusion: Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity.</p>
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<correspondenceTo>Norman Putzki, Department of Neurology, University Clinic Essen, Hufelandstrasse 55, 45122 Essen, Germany (tel.: +49 201 7232363; fax: +49 201 7235901; e‐mail: <email normalForm="norman.putzki@uni-due.de">norman.putzki@uni‐due.de</email>
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Natalizumab has been recommended for the treatment of relapsing–remitting multiple sclerosis (RRMS) in patients with insufficient response to interferon‐beta/glatiramer acetate (DMT) or aggressive MS. The pivotal trials were not conducted to investigate natalizumab monotherapy in this patient population.</p>
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Retrospective, multicenter study in Germany and Switzerland. Five major MS centers reported all RRMS patients who initiated natalizumab ≥12 months prior to study conduction.</p>
<p><b>Results: </b>
Ninety‐seven RRMS patients were included [69% female, mean age 36.5 years, mean Expanded Disability Status Scale (EDSS) 3.4; 93.8% were pre‐treated with DMT], mean treatment duration with natalizumab was 19.3 ± 6.1 months. We found a reduction of the annualized relapse rate from 2.3 to 0.2, 80.4% were relapse free with natalizumab. EDSS improved in 12.4% and 89.7% were progression free (change of >/= 1 EDSS point). Eighty‐six per cent of patients with highly active disease (>/= 2 relapses in the year and >/= 1 Gadolinium (Gd)+ lesion at study entry, <i>n</i>
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Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity.</p>
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<abstract>Background: Natalizumab has been recommended for the treatment of relapsing–remitting multiple sclerosis (RRMS) in patients with insufficient response to interferon‐beta/glatiramer acetate (DMT) or aggressive MS. The pivotal trials were not conducted to investigate natalizumab monotherapy in this patient population.</abstract>
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