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  • Holmen, CarolinaKarolinska Institutet (author)

A Swedish national post-marketing surveillance study of natalizumab treatment in multiple sclerosis

  • Article/chapterEnglish2011

Publisher, publication year, extent ...

  • 2011-01-12
  • SAGE Publications,2011

Numbers

  • LIBRIS-ID:oai:lup.lub.lu.se:17690c72-6205-4b17-b065-30e29e2b00b5
  • https://lup.lub.lu.se/record/2052534URI
  • https://doi.org/10.1177/1352458510394701DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-57324URI
  • https://gup.ub.gu.se/publication/144675URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:122787002URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-69885URI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • Background: A post marketing surveillance study was conducted to evaluate safety and efficacy of natalizumab in Swedish multiple sclerosis (MS) patients since its introduction in August 2006 until March 2010. Methods: Patients were registered in the web-based Swedish MS-registry at 40 locations and evaluated every 6 months. Adverse events and clinical outcomes were recorded. Results: One thousand one hundred and fifty-two patients were included (71.4% female) and 149 patients stopped treatment; the main reason was planned pregnancy. Anti-natalizumab antibodies were found in 4.5% (52 patients) of which 1.6% displayed persistent antibodies. Serious adverse events were rare, but included three cases with progressive multifocal leukoencephalopathy (PML). There were seven fatal cases, probably unrelated to the natalizumab treatment. For relapsing-remitting MS patients (n = 901), mean Expanded Disability Status Scale (EDSS, -10.7%), Multiple Sclerosis Severity Scale (MSSS, -20.4%), Multiple Sclerosis Impact Scale (MSIS-29, physical -9.9%, psychological -13.3%) and Symbol Digit Modalities Test (SDMT, +10.7%) all showed significant improvements during 24 months of treatment with natalizumab. The Swedish web-based MS quality registry proved to function as a platform for post-marketing MS drug surveillance, providing long-term data regarding drug effects and adverse events beyond clinical trials. Conclusions: Our results indicate that natalizumab is generally well tolerated and has sustained efficacy for patients with active MS, though the risk of PML is still an important concern.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Piehl, FredrikKarolinska Institutet (author)
  • Hillert, JanKarolinska Institutet (author)
  • Fogdell-Hahn, AnnaKarolinska Institutet (author)
  • Lundkvist, MalinKarolinska Institutet (author)
  • Karlberg, ElinKarolinska Institutet (author)
  • Nilsson, PetraLund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine,Skanes University Sjukhus(Swepub:lu)neur-pn8 (author)
  • Dahle, CharlotteÖstergötlands Läns Landsting,Linköpings universitet,Klinisk immunologi,Hälsouniversitetet,Klinisk immunologi och transfusionsmedicin(Swepub:liu)chada46 (author)
  • Feltelius, NilsMed Prod Agcy, Uppsala (author)
  • Svenningsson, AndersUmeå universitet,Klinisk neurovetenskap,Umea University(Swepub:umu)ansv0041 (author)
  • Lycke, Jan,1956Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap och rehabilitering,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience and Rehabilitation,University of Gothenburg(Swepub:gu)xlycja (author)
  • Olsson, TomasKarolinska Institutet,Karolinska Institute (author)
  • Karolinska InstitutetNeurologi, Lund (creator_code:org_t)

Related titles

  • In:Multiple Sclerosis Journal: SAGE Publications17:6, s. 708-7191477-09701352-4585

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