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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, Linda (author)
- Karolinska Institutet, Department of Neuroscience, Solna, Sweden
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- Larsson, Veronica (author)
- Karolinska Institutet, Department of Neuroscience, Solna, Sweden
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- Hillert, Jan (author)
- Karolinska Institutet, Department of Neuroscience, Solna, Sweden
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- Nilsson, Petra (author)
- Lund University, Department of Neurology, Lund, Sweden
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- Dahle, Charlotte (author)
- Linköping University, Department of Biomedical and Clinical Sciences, Linköping, Sweden
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- Svenningsson, Anders (author)
- Danderyd Hospital, Department of Clinical Science, Stockholm, Sweden
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- Lycke, Jan (author)
- University of Gothenburg, Department of Clinical Neuroscience, Gothenburg, Sweden
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- Landtblom, Anne-Marie (author)
- Uppsala University, Department of Neuroscience, Uppsala, Sweden
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- Burman, Joachim (author)
- Uppsala University, Department of Medical Science, Uppsala, Sweden
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- Martin, Claes (author)
- Danderyd Hospital, Department of Clinical Science, Stockholm, Sweden
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- Sundström, Peter (author)
- Umeå University, Department of Science, Umeå, Sweden
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- Gunnarsson, Martin, 1973- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Department of Neurology
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- Piehl, Fredrik (author)
- Karolinska Institutet, Department of Neuroscience, Solna, Sweden
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- Olsson, Tomas (author)
- Karolinska Institutet, Department of Neuroscience, Solna, Sweden
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(creator_code:org_t)
- Sage Publications, 2023
- 2023
- English.
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In: Multiple Sclerosis Journal. - : Sage Publications. - 1352-4585 .- 1477-0970. ; 29:Suppl. 3, s. 965-966
- Related links:
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https://urn.kb.se/re...
Abstract
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- Introduction: Natalizumab (NTZ) is a highly effective disease modulatory treatment for relapsing multiple sclerosis (RMS). Post-marketing surveillance is important to evaluate the 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 launch of NTZ 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 were collected from the nationwide Swedish Neuro Registry (NeuroReg). Effectiveness measures were assessed using the Wilcoxon Signed Rank Test.Results: A total of 4011 NTZ patients were included in the IMSE 1 study from August 2006 until March 2023 (72% female; mean age 36 years; 80% RRMS; mean treatment duration 52 months) and 249 had been treated for at least 132 months. Of the 132-month cohort, 75% were female, the mean age was 36 years, 88% had RRMS, and the mean treatment duration was 160 months. The majority were treated with interferons and glatiramer acetate prior to NTZ (68%), where 30% (74/249) discontinued NTZ treatment; 43% (32/74) due to being JCV positive (JCV+), with a mean JCV index of 1.1±0.9 (n=66). Annualized relapse rates dropped from 0.40 in the year before treatment start to 0.04 during treatment, where 68% were entirely free of relapses and 21% had only 1 relapse during the entire treatment period (17% missing data). All clinical effectiveness measures, except EDSS showed statistically significant improvement between baseline and 132 months (p<0.05).From the entire IMSE1 cohort (N=4011), 132 SAEs have 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.Conclusion: NTZ is generally well tolerated and displays sustained effectiveness regarding cognitive, physical and psychological measures, as well as relapse-control. Introduction of JCV testing has led to fewer treated JCV+ patients, likely explaining a drastically reduced incidence of PML.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
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- vet (subject category)
- art (subject category)
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- By the author/editor
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Forsberg, Linda
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Larsson, Veronic ...
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Hillert, Jan
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Nilsson, Petra
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Dahle, Charlotte
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Svenningsson, An ...
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show more...
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Lycke, Jan
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Landtblom, Anne- ...
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Burman, Joachim
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Martin, Claes
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Sundström, Peter
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Gunnarsson, Mart ...
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Piehl, Fredrik
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Olsson, Tomas
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- 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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Örebro University