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A Swedish nationwide pharmaco-epidemiological and genetic study of the long-term safety and effectiveness of dimethyl fumarate (IMSE 5)

Demirbüker, S. Safer (författare)
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Kågström, S. (författare)
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Fält, A. (författare)
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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Berglund, A. (författare)
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Hillert, J. (författare)
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Nilsson, P. (författare)
Department of Neurology, Lund University, Lund, Sweden
Dahle, C. (författare)
Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden
Svenningsson, A. (författare)
Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden
Lycke, J. (författare)
Department of Clinical Neuroscience and Rehabilitation, University of Gothenburg, Gothenburg, Sweden
Landtblom, A. -M (författare)
Department of Neuroscience, Uppsala University, Uppsala, Sweden
Burman, J. (författare)
Department of Neuroscience, Uppsala University, Uppsala, Sweden
Sundström, P. (författare)
Department of Clinical Neuroscience, Umeå University, Umeå, Sweden
Martin, C. (författare)
Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden
Gunnarsson, Martin, 1973- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Department of Neurology
Piehl, F. (författare)
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Olsson, T. (författare)
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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 (creator_code:org_t)
Sage Publications, 2018
2018
Engelska.
Ingår i: Multiple Sclerosis Journal. - : Sage Publications. - 1352-4585 .- 1477-0970. ; 24:Suppl. 2, s. 701-702
Relaterad länk:
https://urn.kb.se/re...
  • Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
Abstract Ämnesord
Stäng  
  • 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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Neurologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Neurology (hsv//eng)

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