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

Holmen, Carolina ; Piehl, Fredrik ; Hillert, Jan ; Fogdell-Hahn, Anna ; Lundkvist, Malin ; Karlberg, Elin ; Nilsson, Petra LU ; Dahle, Charlotte ; Feltelius, Nils and Svenningsson, Anders , et al. (2011) In Multiple Sclerosis Journal 17(6). p.708-719
Abstract
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... (More)
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. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
disease-modifying therapies, multiple sclerosis, relapsing-remitting, Tysabri
in
Multiple Sclerosis Journal
volume
17
issue
6
pages
708 - 719
publisher
SAGE Publications
external identifiers
  • wos:000291729000009
  • scopus:79959452689
ISSN
1477-0970
DOI
10.1177/1352458510394701
language
English
LU publication?
yes
id
17690c72-6205-4b17-b065-30e29e2b00b5 (old id 2052534)
date added to LUP
2016-04-01 10:10:00
date last changed
2022-04-12 02:34:00
@article{17690c72-6205-4b17-b065-30e29e2b00b5,
  abstract     = {{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.}},
  author       = {{Holmen, Carolina and Piehl, Fredrik and Hillert, Jan and Fogdell-Hahn, Anna and Lundkvist, Malin and Karlberg, Elin and Nilsson, Petra and Dahle, Charlotte and Feltelius, Nils and Svenningsson, Anders and Lycke, Jan and Olsson, Tomas}},
  issn         = {{1477-0970}},
  keywords     = {{disease-modifying therapies; multiple sclerosis; relapsing-remitting; Tysabri}},
  language     = {{eng}},
  number       = {{6}},
  pages        = {{708--719}},
  publisher    = {{SAGE Publications}},
  series       = {{Multiple Sclerosis Journal}},
  title        = {{A Swedish national post-marketing surveillance study of natalizumab treatment in multiple sclerosis}},
  url          = {{http://dx.doi.org/10.1177/1352458510394701}},
  doi          = {{10.1177/1352458510394701}},
  volume       = {{17}},
  year         = {{2011}},
}