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A Swedish nationwide pharmaco-epidemiological and genetic study of the long-term safety and effectiveness of dimethyl fumarate (IMSE 5)
Author(s): ,
S. Safer Demirbüker
Affiliations:
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm
,
S. Kågström
Affiliations:
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm
,
A. Fält
Affiliations:
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm
,
A. Berglund
Affiliations:
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm
,
J. Hillert
Affiliations:
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm
,
P. Nilsson
Affiliations:
Department of Neurology, Lund University, Lund
,
C. Dahle
Affiliations:
Department of Clinical and Experimental Medicine, Linköping University, Linköping
,
A. Svenningsson
Affiliations:
Department of Clinical Sciences, Danderyd Hospital, Stockholm
,
J. Lycke
Affiliations:
Department of Clinical Neuroscience and Rehabilitation, University of Gothenburg, Gothenburg
,
A.-M. Landtblom
Affiliations:
Department of Neuroscience, Uppsala University, Uppsala
,
J. Burman
Affiliations:
Department of Neuroscience, Uppsala University, Uppsala
,
P. Sundström
Affiliations:
Department of Clinical Neuroscience, Umeå University, Umeå
,
C. Martin
Affiliations:
Department of Clinical Sciences, Danderyd Hospital, Stockholm
,
M. Gunnarsson
Affiliations:
Department of Neurology, Örebro University, Örebro, Sweden
,
F. Piehl
Affiliations:
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm
T. Olsson
Affiliations:
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm
ECTRIMS Online Library. Safer Demirbüker S.
Oct 12, 2018; 229074
Selin Safer Demirbüker
Selin Safer Demirbüker
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Abstract: P1234

Type: Poster Sessions

Abstract Category: Therapy - Long-term treatment monitoring

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.
Disclosure: The IMSE 5 study has received unrestricted grants from Biogen.
Selin Safer Demirbüker has nothing to disclose.
Stina Kågström has nothing to disclose.
Anna Fält has nothing to disclose.
Anders Berglund is employed at Biogen, Sweden and hold stocks in Biogen.
Jan Hillert has received honoraria for serving on advisory boards for Biogen, Sanofi-Genzyme and Novartis and speaker´s fees from Biogen, Novartis, Merck-Serono, Bayer-Schering, Teva and Sanofi-Genzyme. He has served as P.I. for projects, or received unrestricted research support from, BiogenIdec, Merck-Serono, TEVA, Sanofi-Genzyme and Bayer-Schering. This MS research was funded by the Swedish Research Council and the Swedish Brain foundation.
Petra Nilsson has received travel support from Bayer Schering Pharma, Merck Serono, Biogen and Sanofi Genzyme, honoraria for lectures and advisory boards from Merck Serono and Sanofi Genzyme, advisory boards for Novartis and Roche, lectures for Biogen and has received unrestricted grants from Biogen.
Charlotte Dahle has received unrestricted research grants or honoraria for lectures or advisory boards from Biogen, Novartis, Merck Serono, Teva and Sanofi Genzyme.
Anders Svenningsson has nothing to disclose.
Jan Lycke has received travel support and/or lecture honoraria from Bayer Schering Pharma, Biogen, Merck, Novartis, Teva and Sanofi Genzyme; has served on scientific advisory boards for Almirall, Teva, Biogen, Merck, Novartis and Sanofi Genzyme; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva.
Anne-Marie Landtblom has received honoraria from Merck Serono, Teva, Roche, Biogen Sanofi Genzyme.
Joachim Burman has received travel support and/or lecture honoraria from Almirall, Biogen, Sanofi Genzyme, Hospira and Merck Serono; has received unconditional research grants from Biogen and Merck Serono.
Martin Gunnarsson has nothing to disclose.
Peter Sundström has nothing to disclose.
Claes Martin has received honoraria for lectures and advisory boards from Merck Serono and Sanofi Genzyme.
Fredrik Piehl has received unrestricted academic research grants from Biogen, Genzyme and Novartis, and travel support and/or compensation for lectures and/or participation in advisory boards from Biogen, Merck Serono, Novartis, Sanofi Genzyme and Teva, which have been exclusively used for the support of research activities.
Tomas Olsson has received unrestricted research grants or honoraria for lectures or advisory boards from Biogen, Novartis, Novartis, Merck, Roche and Sanofi Genzyme.

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