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Efficacy and tolerability of natalizumab in relapsing–remitting multiple sclerosis patients: a post-marketing observational study

  • Session II- Natalizumab: Italian Experience
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Abstract

To evaluate the efficacy and safety of natalizumab in patients with active relapsing–remitting multiple sclerosis (MS). We included 285 MS patients receiving natalizumab. Clinical, neuroradiological and safety data were registered every 6 months. Neutralizing antibodies (NABs) were tested after 6 months of treatment. After 1 year, the annualized relapse rate decreased to 0.26, with a significant reduction compared to the previous year (2.13). At 24 months the proportion of “relapse free” patients was 78% while that of “MRI free” patients was 69%. Considering clinical and MRI cumulative activity, “disease free” patients were 63% at 24 months. A total of 18 patients showed NABs positivity. We reported 34 cases of treatment interruptions. In conclusion, our data confirm the remarkable efficacy of natalizumab in a group of patients with higher disease activity than that of pivotal studies.

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Conflict of interest statement

Within the past year Prof. Comi received personal compensation from Bayer-Schering, Serono Symposia International Foundation, Merck Serono International and TEVA Pharmaceutical Ind. Ltd., Sanofi-Aventis and Biogen-Dompè for consulting services. He has received personal compensation for speaking activities. TEVA Pharmaceutical Ind. Ltd, Sanofi-Aventis, Serono Symposia International Foundation, Biogen-Dompè and Bayer-Schering. Dr. LME Grimaldi has received appearance fees, travel support, research grant, from Biogen-Dompè. In the last five years Dr. A. Ghezzi received consulting and lecture fees form Bayer-Schering, Sanofi-Aventis, Novartis, Biogen-Dompè, Merk-Serono, Actelion. In the last year Dr. L. Moiola and Dr. S. Bucello received personal compensation for speaking activity from Biogen-Dompè. Dr. F. Sangalli, Dr. P. Annovazzi, Dr. A. Rizzo, Dr. M. Radaelli and Dr. G. Vitello have nothing to disclose.

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Authors and Affiliations

  1. Department of Neurology, INSPE, IRCCS H San Raffaele, via Olgettina 48, 20132, Milan, Italy

    F. Sangalli, L. Moiola, S. Bucello, M. Radaelli, V. Martinelli & G. Comi

  2. Centro Studi SM, H S. Antonio Abate, Gallarate, VA, Italy

    P. Annovazzi, A. Rizzo & A. Ghezzi

  3. Ospedale Giglio-HSR, Cefalù, PA, Italy

    G. Vitello & L. M. E. Grimaldi

Authors
  1. F. Sangalli
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  2. L. Moiola
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  3. S. Bucello
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  4. P. Annovazzi
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  5. A. Rizzo
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  6. M. Radaelli
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  7. G. Vitello
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  8. L. M. E. Grimaldi
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  9. A. Ghezzi
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  10. V. Martinelli
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  11. G. Comi
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Corresponding author

Correspondence to G. Comi.

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Sangalli, F., Moiola, L., Bucello, S. et al. Efficacy and tolerability of natalizumab in relapsing–remitting multiple sclerosis patients: a post-marketing observational study. Neurol Sci 31 (Suppl 3), 299–302 (2011). https://doi.org/10.1007/s10072-010-0344-z

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  • DOI: https://doi.org/10.1007/s10072-010-0344-z

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