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Improved clinical o...
Improved clinical outcomes in patients treated with natalizumab for at least 11 years - real-world data from a swedish national post-marketing surveillance study (IMSE 1)
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- Forsberg, L. (författare)
- Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden
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- Ekström, E. (författare)
- Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden
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- Hillert, J. (författare)
- Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden
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- Nilsson, P. (författare)
- Lund University, Department of Neurology, Lund, Sweden
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- Dahle, C. (författare)
- Linköping University, Department of Biomedical and Clinical Sciences, Linköping, Sweden
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- Svenningsson, A. (författare)
- Danderyd Hospital, Department of Clinical Sciences, Stockholm, Sweden
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- Lycke, J. (författare)
- University of Gothenburg, Department of Clinical Neuroscience, Göteborg, Sweden
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- Landtblom, A. -M (författare)
- Uppsala University, Department of Neuroscience, Uppsala, Sweden
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- Burman, J. (författare)
- Uppsala University, Department of Neuroscience, Uppsala, Sweden
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- Martin, C. (författare)
- Danderyd Hospital, Department of Clinical Sciences, Stockholm, Sweden
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- Sundström, P. (författare)
- Umeå University, Department of Clinical Neuroscience, Umeå, Sweden
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- Gunnarsson, Martin, 1973- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Department of Neurology
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- Piehl, F. (författare)
- Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden
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- Olsson, T. (författare)
- Karolinska Institutet, Department of Clinical Neuroscience, Stockholm, Sweden
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(creator_code:org_t)
- Sage Publications, 2022
- 2022
- Engelska.
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Ingår i: Multiple Sclerosis Journal. - : Sage Publications. - 1352-4585 .- 1477-0970. ; 28:Suppl. 3, s. 352-353
- Relaterad länk:
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https://urn.kb.se/re...
Abstract
Ämnesord
Stäng
- Introduction: Natalizumab (NTZ) is a highly effective disease modulatory treatment for relapsing-remitting multiple sclerosis (RRMS). Post-marketing surveillance is important for evaluation of long-term safety and effectiveness in a real-world setting. To this end the “Immunomodulation and Multiple Sclerosis Epidemiology Study” (IMSE 1) was initiated upon NTZ launch in Sweden (Aug 2006).Objectives/Aims: To follow-up the long-term effectiveness and safety of NTZ in a real-world setting.Methods: Adverse events (AEs), Serious AEs (SAEs), John Cunningham virus status (JCV) and clinical effectiveness measures; Extended Disability Status Scale (EDSS), Multiple Sclerosis Severity Scale (MSSS), Symbol Digit Modalities Test (SDMT) and Multiple Sclerosis Impact Scale (MSIS-29) data is collected from the nationwide Swedish Neuro Registry (NeuroReg). Effectiveness measures were assessed using the Wilcoxon Signed Rank Test.Results: A total of 3622 NTZ patients were included in the IMSE 1 study from August 2006 until March 2022 (72% female; mean age 36 years; 80% RRMS; mean treatment duration 49 months) and 186 had been treated for at east 132 months. Of the 132-month cohort, 73% were female, the mean age was 36 years, 88% had RRMS, and the mean treatment duration was 155 months. The majority were treated with interferons and glatiramer acetate prior NTZ (64%). 25% (47/186) discontinued NTZ treatment of which 47% (n=22) discontinued due to JCV positive (JCV+). In total, 30% (55/186) of these patients were JCV+ with a mean JCV index of 1.2±1.0 (2% missing data). Relapses before treatment were reduced from 380/1000 patient years to 43/1000 during treatment, 71% were relapse-free and 18% had 1 relapse during the entire treatment period (15% missing data). Most clinical effectiveness measures, MSSS, MSIS-29 and SDMT showed statistically significant improvement between baseline and 132 months (p<0.05). Over the entire observation time, 125 SAEs had been reported to the Swedish MPA including 9 cases (2 fatal) of progressive multifocal leukoencephalopathy (PML) of which 8 occurred between 2008 and 2012, and one in 2018.Conclusions: NTZ is generally well tolerated with sustained effectiveness regarding cognitive, physical and psychological measures, as well as relapse-control. Introduction of JCV testing has led to fewer treated JCV+ patients, which likely explains a drastic drop in number of reported cases of PML.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
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Forsberg, L.
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Ekström, E.
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Hillert, J.
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Nilsson, P.
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Dahle, C.
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Svenningsson, A.
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visa fler...
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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