caa a22 4500 44535836X CHVBK 20180317142907.0 cr unu---uuuuu 170323e20110101xx s 000 0 eng 10.1007/s10072-010-0345-y doi (NATIONALLICENCE)springer-10.1007/s10072-010-0345-y Swedish natalizumab (Tysabri) multiple sclerosis surveillance study [Elektronische Daten] [Fredrik Piehl, C. Holmén, J. Hillert, T. Olsson] 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 ≥24months. 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 24months 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. Springer-Verlag, 2010 Natalizumab nationallicence Multiple sclerosis nationallicence Antibodies, monoclonals/adverse effects nationallicence Antibodies, monoclonals/therapeutic use nationallicence Product surveillance nationallicence Piehl Fredrik Department of Clinical Neuroscience, Karolinska Institutet, 171 76, Stockholm, Sweden aut Holmén C. Department of Clinical Neuroscience, Karolinska Institutet, 171 76, Stockholm, Sweden aut Hillert J. Department of Clinical Neuroscience, Karolinska Institutet, 171 76, Stockholm, Sweden aut Olsson T. Department of Clinical Neuroscience, Karolinska Institutet, 171 76, Stockholm, Sweden aut Neurological Sciences Springer Milan 31(2011-01-01), 289-293 1590-1874 31<289 2011 31 10072 https://doi.org/10.1007/s10072-010-0345-y text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10072-010-0345-y text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Piehl Fredrik Department of Clinical Neuroscience, Karolinska Institutet, 171 76, Stockholm, Sweden aut NATIONALLICENCE 700 1- Holmén C. Department of Clinical Neuroscience, Karolinska Institutet, 171 76, Stockholm, Sweden aut NATIONALLICENCE 700 1- Hillert J. Department of Clinical Neuroscience, Karolinska Institutet, 171 76, Stockholm, Sweden aut NATIONALLICENCE 700 1- Olsson T. Department of Clinical Neuroscience, Karolinska Institutet, 171 76, Stockholm, Sweden aut NATIONALLICENCE 773 0- Neurological Sciences Springer Milan 31(2011-01-01), 289-293 1590-1874 31<289 2011 31 10072 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer