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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 ...

  • Sage Publications,2018
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:oru-70216
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-70216URI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:vet swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Funding Agencies:BiogenNovartis  Merck Serono  Teva  Sanofi Genzyme  Genzyme
  • 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 (author)
  • Fält, A.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden (author)
  • Berglund, A.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden (author)
  • Hillert, J.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden (author)
  • Nilsson, P.Department of Neurology, Lund University, Lund, Sweden (author)
  • Dahle, C.Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden (author)
  • Svenningsson, A.Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden (author)
  • Lycke, J.Department of Clinical Neuroscience and Rehabilitation, University of Gothenburg, Gothenburg, Sweden (author)
  • Landtblom, A. -MDepartment of Neuroscience, Uppsala University, Uppsala, Sweden (author)
  • Burman, J.Department of Neuroscience, Uppsala University, Uppsala, Sweden (author)
  • Sundström, P.Department of Clinical Neuroscience, Umeå University, Umeå, Sweden (author)
  • Martin, C.Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden (author)
  • Gunnarsson, Martin,1973-Örebro universitet,Institutionen för medicinska vetenskaper,Department of Neurology(Swepub:oru)mign (author)
  • Piehl, F.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden (author)
  • Olsson, T.Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden (author)
  • Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, SwedenDepartment of Neurology, Lund University, Lund, Sweden (creator_code:org_t)

Related titles

  • In:Multiple Sclerosis Journal: Sage Publications24:Suppl. 2, s. 701-7021352-45851477-0970

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