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Efficacy of natalizumab in second line therapy of relapsing–remitting multiple sclerosis: results from a multi‐center study in German speaking countries
Author(s) -
Putzki N.,
Yaldizli O.,
Mäurer M.,
Cursiefen S.,
Kuckert S.,
Klawe C.,
Maschke M.,
Tettenborn B.,
Limmroth V.
Publication year - 2010
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/j.1468-1331.2009.02728.x
Subject(s) - natalizumab , medicine , glatiramer acetate , multiple sclerosis , expanded disability status scale , discontinuation , population , relapsing remitting , gastroenterology , immunology , environmental health
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. 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. 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). Conclusion: Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity.