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A Swedish nationwid...
A Swedish nationwide pharmaco-epidemiological study of the long-term safety and effectiveness of fingolimod (IMSE 2)
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- Fält, A. (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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- Demirbüker, S. Safer (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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- Martin, C. (author)
- Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden
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- Sundström, P. (author)
- Department of Clinical Neuroscience, Umeå University, Umeå, 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. 696-697
- Related links:
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https://urn.kb.se/re...
Abstract
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- Background: Fingolimod (FGL) is an oral therapy for patients with relapsing-remitting multiple sclerosis (RRMS) and the efficacy has been shown in phase II and III studies. However; long-term surveillance and safety is important, therefore FGL is included in the Swedish “Immunomodulation and Multiple Sclerosis Epidemiology Study 2” (IMSE 2).Objective: To follow up the effectiveness and long-term safety of FGL in a real-world setting.Methods: Swedish MS patients are registered into the nationwide Swedish Neuro Registry (NeuroReg). IMSE 2 includes data of adverse events (AEs) and clinical measures; 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 - 5 Dimension Test (EQ-5D) and Visual Analogue Scale (VAS), obtained from NeuroReg.Results: From September 2011 until April 2018, 1617 patients (67% female; 91% RRMS) were included in IMSE 2. At treatment start 38 patients were ≤20 years (yr), 308 aged 21-30 yr and 1271 aged >30 yr. Mean treatment duration was 34 months. 852 patients were currently treated with FGL at cut-off date and 1230 patients had been treated for at least 12 months. In total, 39% switched treatment from interferons or glatiramer acetate, 26% from natalizumab and 5% from dimethyl fumarate or teriflunomide. 803 patients have discontinued FGL at some point, mainly due to lack of effect (43%) or AEs (34%), most patients switched to rituximab after FGL discontinuation. Relapses were reduced from 281 to 87/1000 patient years (PY) when comparing before and during FGL treatment. In patients aged ≤20 yr, 21-30 yr and >30 yr relapses were reduced from 694 to 144/1000 PY, 455 to 129/1000 PY and 258 to 77/1000 PY, respectively. After 12 months significant improvements were seen in EQ-5D (0.7 to 0.8, n=752), MSSS (3.1 to 2.9, n=410), MSIS-29 Physical (21.1 to 20.0 n=812), MSIS-29 Psychological (29.2 to 24.9, n=812), SDMT (54.3 to 57.0, n=751) and VAS (70.9 to 72.8, n=692). When analysing age groups separately significant improvements were seen in MSSS, SDMT, and MSIS-29 Psychological in patients aged 21-30 yr and >30 yr. EQ-5D, VAS and MSIS-29 Physical significantly improved in patients aged >30 yr.Conclusions: FGL is a generally well-tolerated drug that reduces the clinical activity in MS patients. NeuroReg functions well as a drug surveillance platform, enabling monitoring of long-term effectiveness and AEs.
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)
- art (subject category)
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- By the author/editor
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Fält, A.
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Kågström, S.
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Demirbüker, S. S ...
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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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Martin, C.
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Sundström, P.
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Gunnarsson, Mart ...
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Piehl, F.
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Olsson, T.
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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