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Preliminary Results of the “Sovet” Observational Program for Use of Natalizumab in the Treatment of Patients with Remitting Multiple Sclerosis

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The “Sovet” post-marketing observational program was started in 2011. A total of 69 patients with the remitting form of multiple sclerosis (MS) treated with the second-generation DMD natalizumab (NZ) were studied. NZ infusions were given over 1 h every four weeks for 12 months. Treatment produced significant reductions in the frequency of exacerbations of disease, from 2.22 ± 0.98 to 0.18 ± 0.42 per year, along with a tendency to decreased EDSS scores, from 3.69 ± 1.0 to 3.37 ± 1.17. Adverse events occurred during treatment in 11 patients, each reaction being seen in no more than one person; treatment withdrawal was required in only one case, because of a generalized allergic reaction. The data presented here supplement published data on the positive effects of NZ on the course and signs of MS. These results lead to the conclusion that strict selection of patients and correct management during NZ treatment can provide a positive balance between the benefits of this treatment and its potential risks.

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Authors and Affiliations

  1. Moscow City Multiple Sclerosis Center, City Clinical Hospital, No. 11., Moscow, Russia

    E. V. Popova & M. V. Davydovskaya

  2. Neurology Scientific Center, Russian Academy of Medical Sciences, Moscow, Russia

    L. V. Brylev

Authors
  1. E. V. Popova
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  2. L. V. Brylev
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  3. M. V. Davydovskaya
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study group

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Correspondence to M. V. Davydovskaya.

Additional information

The principal investigators in the “Sovet” study program and the members of the coordinating committee are: A. N. Boiko, Ya. V. Vlasov, I. A. Zavalishin, M. N. Zakharova, E. P. Evdoshenko, S. V. Kotov, L. I. Volkova, N. A. Malkova, A. S. Fedyanin, Yu. V. Trinitatskii, K. Z. Bakhtiyarova, L. A. Tsukurova, G. N. Bel'skaya, E. I. Ivashinenkova, A. A. Gavrilenko, T. A. Shcherbanosova, A. S. Rozhdestvenskii, N. N. Spirin, and I. O. Stepanov.

Translated from Zhurnal Nevrologii i Psikhiatrii imeni S. S. Korsakova, Vol. 113, No. 2, Iss. II, Multiple Sclerosis, pp. 79–82, February 2013.

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Popova, E.V., Brylev, L.V., Davydovskaya, M.V. et al. Preliminary Results of the “Sovet” Observational Program for Use of Natalizumab in the Treatment of Patients with Remitting Multiple Sclerosis. Neurosci Behav Physi 44, 520–523 (2014). https://doi.org/10.1007/s11055-014-9943-0

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  • DOI: https://doi.org/10.1007/s11055-014-9943-0

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