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A Swedish nationwid...
A Swedish nationwide pharmaco-epidemiological and genetic study of the long-term safety and effectiveness of natalizumab (IMSE 1)
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- Kågström, S. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Fält, A. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Demirbüker, S. Safer (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Berglund, A. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Hillert, J. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Nilsson, P. (författare)
- Department of Neurology, Lund University, Lund, Sweden
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- Dahle, C. (författare)
- Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden
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- Svenningsson, A. (författare)
- Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden
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- Lycke, J. (författare)
- Department of Clinical Neuroscience and Rehabilitation, University of Gothenburg, Göteborg, Sweden
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- Landtblom, A. -M (författare)
- Department of Neuroscience, Uppsala University, Uppsala, Sweden
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- Burman, J. (författare)
- Department of Neuroscience, Uppsala University, Uppsala, Sweden
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- Martin, C. (författare)
- Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden
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- Sundström, P. (författare)
- Department of Clinical Neuroscience, Umeå University, Umeå, Sweden
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- Gunnarsson, Martin, 1973- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Department of Neurology
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- Piehl, F. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Olsson, T. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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(creator_code:org_t)
- Sage Publications, 2018
- 2018
- Engelska.
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Ingår i: Multiple Sclerosis Journal. - : Sage Publications. - 1352-4585 .- 1477-0970. ; 24:Suppl. 2, s. 699-700
- Relaterad länk:
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https://urn.kb.se/re...
Abstract
Ämnesord
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- Background: Natalizumab (NTZ) is a highly effective disease modulatory treatment for relapsing-remitting multiple sclerosis (RRMS). Post-marketing surveillance is important for determination of long-term safety and effectiveness in a real-world setting. To this end the “Immunomodulation and Multiple Sclerosis Epidemiology Study 1” (IMSE 1) was initiated upon NTZ launch in Sweden (Aug 2006).Objective: To follow-up the long-term safety and effectiveness of NTZ in a real-world setting.Methods: In Sweden MS patients are registered in the nationwide Swedish Neuro Registry (NeuroReg). IMSE 1 includes patients starting NTZ treatment and data is collected from NeuroReg. Adverse events (AEs), JC-virus status (JCV) and clinical effectiveness measures are registered prospectively.Results: 3052 patients (72% female; 82% RRMS; mean age at treatment start 36 years; mean treatment duration 45.9 months) have been included in IMSE 1 from August 2006 until April 2018. A total of 1234 RRMS patients where included year ≥2011 (JCV test introduction) and had information on JCV (482 anti-JCV anti-bodies (JCV+), 752 JCV negative (JCV-)). 691 of these patients were currently treated with NZT at cutoff date, 88 (13%) of which were JCV+ with a mean JCV index at 1.1±1.1. A total of 612/1234 (49%) discontinued NTZ treatment at some time point of which 266/403 (66%) JCV+ discontinued due to JCV+. JCV- patients mainly discontinued due to pregnancy/planning pregnancy (78/209, 37%) and other reasons (57/209, 27%). The one and two-year drug survival rate was 79% and 45% for JCV+ and 90% and 82% for JCV-. The overall drug survival rate was 16% for JCV+ and 72% for JCV-. In patients with continuous NTZ treatment for ≥2 years (n=738), long lasting stabilization of disease activity was observed. From year 2006 until cutoff, 96 Serious AEs had been reported to the Swedish MPA and included 8 cases (1 fatal) of progressive multifocal leukoencephalopathy (PML), reported between 2008 and 2012. A total of 14 patients have died during or within 6 months after NTZ discontinuation, as reported in NeuroReg. None were reported to be associated to NTZ.Conclusions: NeuroReg functions well as a post-marketing drug surveillance platform, providing long-term data on drug effects and AEs. NTZ is generally well tolerated with sustained effective-ness. The introduction of JCV testing has led to fewer treated JCV+ patients, which likely explains a reduced incidence of PML.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
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Kågström, S.
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Fält, A.
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Demirbüker, S. S ...
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Berglund, A.
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Hillert, J.
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Nilsson, P.
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visa fler...
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Dahle, C.
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Svenningsson, A.
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Lycke, J.
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Landtblom, A. -M
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Burman, J.
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Martin, C.
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Sundström, P.
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Gunnarsson, Mart ...
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Piehl, F.
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Olsson, T.
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Örebro universitet