Abstract
A post-marketing surveillance program was implemented to monitor the safety and open label efficacy of natalizumab since its launch in Sweden August 2006. Patients are registered in the Swedish multiple sclerosis (MS)-registry that has a nationwide coverage using a standardized follow-up that includes EDSS, MSSS, SDMT, MSIS-29, and recording of adverse events (AEs). As of 31 January, 2010, 1,115 patients had been included, of which 363 were treated ≥24 months. Dropout rate was 10%, mainly due to planned pregnancy. Serious AEs were rare, but included three cases of progressive multifocal leukoencephalopathy (PML), none of which had received previous immunosuppressive therapy. All analyzed clinical outcome parameters showed significant improvements compared to baseline for patients exceeding 24 months of treatment. Our results demonstrate good general tolerability and sustained efficacy of natalizumab for patients with severe MS, though the risk of PML remains a concern.
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Acknowledgments
The authors thank all participating physicians, nurses, and patients. The Swedish MS registry receives support from the Swedish national board of health and welfare. The post-marketing surveillance program for natalizumab received an initial un-conditional grant support from BiogenIdec Sweden AB.
Conflict of interest statement
C. Holmen declares that she has no conflict of interests related to the publication of this article. T. Olsson and J. Hillert received personal compensation for consultancy or lecture fees from BiogenIdec, MerckSerono, sanofi aventis, BayerSchering and/or Novartis. F. Piehl, T. Olsson and J. Hillert received unrestricted research grants from BiogenIdec, MerckSerono and/or BayerSchering.
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Piehl, F., Holmén, C., Hillert, J. et al. Swedish natalizumab (Tysabri) multiple sclerosis surveillance study. Neurol Sci 31 (Suppl 3), 289–293 (2011). https://doi.org/10.1007/s10072-010-0345-y
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DOI: https://doi.org/10.1007/s10072-010-0345-y