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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 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
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Contribution to journal
publication status
published
subject
keywords
disease-modifying therapies, multiple sclerosis, relapsing-remitting, Tysabri
in
Multiple Sclerosis
volume
17
issue
6
pages
708 - 719
publisher
Arnold, Hodder Headline PLC
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
2011-08-02 09:01:25
date last changed
2017-08-27 03:14:39
@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},
  keyword      = {disease-modifying therapies,multiple sclerosis,relapsing-remitting,Tysabri},
  language     = {eng},
  number       = {6},
  pages        = {708--719},
  publisher    = {Arnold, Hodder Headline PLC},
  series       = {Multiple Sclerosis},
  title        = {A Swedish national post-marketing surveillance study of natalizumab treatment in multiple sclerosis},
  url          = {http://dx.doi.org/10.1177/1352458510394701},
  volume       = {17},
  year         = {2011},
}