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A Swedish national ...
A Swedish national post-marketing surveillance study of natalizumab treatment in multiple sclerosis
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- Holmen, Carolina (author)
- Karolinska Institutet
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- Piehl, Fredrik (author)
- Karolinska Institutet
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- Hillert, Jan (author)
- Karolinska Institutet
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- Fogdell-Hahn, Anna (author)
- Karolinska Institutet
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- Lundkvist, Malin (author)
- Karolinska Institutet
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- Karlberg, Elin (author)
- Karolinska Institutet
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- Nilsson, Petra (author)
- Lund 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
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- Dahle, Charlotte (author)
- Östergötlands Läns Landsting,Linköpings universitet,Klinisk immunologi,Hälsouniversitetet,Klinisk immunologi och transfusionsmedicin
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- Feltelius, Nils (author)
- Med Prod Agcy, Uppsala
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- Svenningsson, Anders (author)
- Umeå universitet,Klinisk neurovetenskap,Umea University
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- Lycke, Jan, 1956 (author)
- Gothenburg 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
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- Olsson, Tomas (author)
- Karolinska Institutet,Karolinska Institute
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(creator_code:org_t)
- 2011-01-12
- 2011
- English.
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In: Multiple Sclerosis Journal. - : SAGE Publications. - 1477-0970 .- 1352-4585. ; 17:6, s. 708-719
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Abstract
Subject headings
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- 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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Keyword
- disease-modifying therapies
- multiple sclerosis
- relapsing-remitting
- Tysabri
- disease-modifying therapies; multiple sclerosis; relapsing-remitting; Tysabri
- MEDICINE
Publication and Content Type
- art (subject category)
- ref (subject category)
Find in a library
To the university's database
- By the author/editor
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Holmen, Carolina
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Piehl, Fredrik
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Hillert, Jan
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Fogdell-Hahn, An ...
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Lundkvist, Malin
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Karlberg, Elin
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Nilsson, Petra
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Dahle, Charlotte
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Feltelius, Nils
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Svenningsson, An ...
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Lycke, Jan, 1956
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Olsson, Tomas
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Neurology
- Articles in the publication
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Multiple Scleros ...
- By the university
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Lund University
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Umeå University
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University of Gothenburg
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Karolinska Institutet
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Linköping University