Efficacy of natalizumab in second line therapy of relapsing–remitting multiple sclerosis: results from a multi-center study in German speaking countries
Version of Record online: 9 JUL 2009
© 2009 The Author(s). Journal compilation © 2009 EFNS
European Journal of Neurology
Volume 17, Issue 1, pages 31–37, January 2010
How to Cite
Putzki, N., Yaldizli, O., Mäurer, M., Cursiefen, S., Kuckert, S., Klawe, C., Maschke, M., Tettenborn, B. and Limmroth, V. (2010), Efficacy of natalizumab in second line therapy of relapsing–remitting multiple sclerosis: results from a multi-center study in German speaking countries. European Journal of Neurology, 17: 31–37. doi: 10.1111/j.1468-1331.2009.02728.x
- Issue online: 18 DEC 2009
- Version of Record online: 9 JUL 2009
- Received 16 April 2009 Accepted 25 May 2009
- disease modifying therapy;
- multiple sclerosis;
- treatment failure
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.