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A Swedish nationwid...
A Swedish nationwide pharmaco-epidemiological and genetic study of the long-term safety and effectiveness of dimethyl fumarate (IMSE 5)
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- Demirbüker, S. Safer (author)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Kågström, S. (author)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Fält, A. (author)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Berglund, A. (author)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Hillert, J. (author)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Nilsson, P. (author)
- Department of Neurology, Lund University, Lund, Sweden
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- Dahle, C. (author)
- Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden
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- Svenningsson, A. (author)
- Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden
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- Lycke, J. (author)
- Department of Clinical Neuroscience and Rehabilitation, University of Gothenburg, Gothenburg, Sweden
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- Landtblom, A. -M (author)
- Department of Neuroscience, Uppsala University, Uppsala, Sweden
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- Burman, J. (author)
- Department of Neuroscience, Uppsala University, Uppsala, Sweden
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- Sundström, P. (author)
- Department of Clinical Neuroscience, Umeå University, Umeå, Sweden
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- Martin, C. (author)
- Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden
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- Gunnarsson, Martin, 1973- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Department of Neurology
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- Piehl, F. (author)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Olsson, T. (author)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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(creator_code:org_t)
- Sage Publications, 2018
- 2018
- English.
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In: Multiple Sclerosis Journal. - : Sage Publications. - 1352-4585 .- 1477-0970. ; 24:Suppl. 2, s. 701-702
- Related links:
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https://urn.kb.se/re...
Abstract
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- Background: Dimethyl fumarate (DMF) is an oral therapy for relapsing-remitting multiple sclerosis (RRMS), which has been included in the Swedish post-market surveillance study “Immunomodulation and Multiple Sclerosis Epidemiology 5” (IMSE 5) in order to monitor and determine the long-term safety and effectiveness in a real-world setting.Objectives: To follow-up the long-term safety and effectiveness of DMF in a real-world setting.Methods: MS patients are registered into the nationwide Swedish Neuro Registry (NeuroReg) in Sweden. The IMSE 5 study obtains descriptive data of adverse events (AEs), Extended Disability Status Scale (EDSS), Multiple Sclerosis Severity Scale (MSSS), Symbol Digit Modalities Test (SDMT), Multiple Sclerosis Impact Scale (MSIS-29), European Quality of Life - Five Dimensions Test (EQ-5D) and Visual Analog Scale (VAS) from NeuroReg. Drug survival was measured using the Kaplan-Meier curve and effectiveness measures were assessed using the Wilcoxon Signed Rank Test.Results: 2010 DMF-treated patients have been included in the IMSE 5 study between March 2014 and April 2018. 73 % were female and the mean age at treatment start was 40.6 years. The mean treatment duration was 22.3 months. 92 % of the patients had RRMS with 2 % missing data on MS phenotype. Most patients switched from interferon and glaimer acetat (41 %) and 24 % of the patients were treatment naïve (13 % were missing data on prior treatment). The overall one year drug survival was 74 % and 889 patients terminated their treatment at some point. Most patients (39 %) switched to rituximab (15 % have no new treatment registered). The most common reason for discontinuation was AEs (53 %) and lack of effect (29 %). 227 (11 %) patients have continued treatment for ≥36 months. In patients treated with DMF continuously for ≥24 months (n=918), significant improvements in mean values at 24 months of treatment compared to mean baseline values have been noted for EDSS (1.9 ± 1.6 to 1.6 ± 1.6, n=196); MSSS (2.5 ± 2.4 to 2.0 ± 2.0, n=145); SDMT (52.6 ± 11.0 to 53.8 ± 11.7, n=315); MSIS-29 Psychological Subscale (26.3 ± 22.8 to 21.8 ± 20.6, n=337); and EQ-5D (0.76 ± 0.23 to 0.81 ± 0.20, n=284).Conclusions: NeuroReg proves to function well as a post-marketing drug surveillance platform, providing data regarding drug effectiveness and AEs. A longer follow-up period is needed to assess the real-world effectiveness and safety of DMF.
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)
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- By the author/editor
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Demirbüker, S. S ...
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Kågström, S.
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Fält, A.
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Berglund, A.
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Hillert, J.
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Nilsson, P.
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show more...
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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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Sundström, P.
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Martin, C.
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Gunnarsson, Mart ...
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Piehl, F.
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Olsson, T.
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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
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Multiple Scleros ...
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Örebro University