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A Swedish nationwid...
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Demirbüker, S. SaferDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
(author)
A Swedish nationwide pharmaco-epidemiological and genetic study of the long-term safety and effectiveness of dimethyl fumarate (IMSE 5)
- Article/chapterEnglish2018
Publisher, publication year, extent ...
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Sage Publications,2018
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:oru-70216
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https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-70216URI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:vet swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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Funding Agencies:BiogenNovartis Merck Serono Teva Sanofi Genzyme Genzyme
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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.
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Kågström, S.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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Fält, A.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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Berglund, A.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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Hillert, J.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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Nilsson, P.Department of Neurology, Lund University, Lund, Sweden
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Dahle, C.Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden
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Svenningsson, A.Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden
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Lycke, J.Department of Clinical Neuroscience and Rehabilitation, University of Gothenburg, Gothenburg, Sweden
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Landtblom, A. -MDepartment of Neuroscience, Uppsala University, Uppsala, Sweden
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Burman, J.Department of Neuroscience, Uppsala University, Uppsala, Sweden
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Sundström, P.Department of Clinical Neuroscience, Umeå University, Umeå, Sweden
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Martin, C.Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden
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Gunnarsson, Martin,1973-Örebro universitet,Institutionen för medicinska vetenskaper,Department of Neurology(Swepub:oru)mign
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Piehl, F.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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Olsson, T.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, SwedenDepartment of Neurology, Lund University, Lund, Sweden
(creator_code:org_t)
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In:Multiple Sclerosis Journal: Sage Publications24:Suppl. 2, s. 701-7021352-45851477-0970
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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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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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