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Sökning: id:"swepub:oai:DiVA.org:oru-70214" > A Swedish nationwid...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00005498naa a2200433 4500
001oai:DiVA.org:oru-70214
003SwePub
008181120s2018 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-702142 URI
040 a (SwePub)oru
041 a engb eng
042 9 SwePub
072 7a vet2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Fält, A.u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden4 aut
2451 0a A Swedish nationwide pharmaco-epidemiological study of the long-term safety and effectiveness of fingolimod (IMSE 2)
264 1b Sage Publications,c 2018
338 a print2 rdacarrier
500 a Funding Agencies:Novartis  Biogenldec  Merck-Serono  TEVA  Sanofi-Genzyme  Bayer-Schering  Merck Serono  Sanofi Genzyme 
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Neurologi0 (SwePub)302072 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Neurology0 (SwePub)302072 hsv//eng
7001 a Kågström, S.u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden4 aut
7001 a Demirbüker, S. Saferu Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden4 aut
7001 a Hillert, J.u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden4 aut
7001 a Nilsson, P.u Department of Neurology, Lund University, Lund, Sweden4 aut
7001 a Dahle, C.u Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden4 aut
7001 a Svenningsson, A.u Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden4 aut
7001 a Lycke, J.u Department of Clinical Neuroscience and Rehabilitation, University of Gothenburg, Gothenburg, Sweden4 aut
7001 a Landtblom, A. -Mu Department of Neuroscience, Uppsala University, Uppsala, Sweden4 aut
7001 a Burman, J.u Department of Neuroscience, Uppsala University, Uppsala, Sweden4 aut
7001 a Martin, C.u Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden4 aut
7001 a Sundström, P.u Department of Clinical Neuroscience, Umeå University, Umeå, Sweden4 aut
7001 a Gunnarsson, Martin,d 1973-u Örebro universitet,Institutionen för medicinska vetenskaper,Department of Neurology4 aut0 (Swepub:oru)mign
7001 a Piehl, F.u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden4 aut
7001 a Olsson, T.u Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden4 aut
7102 a Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Swedenb Department of Neurology, Lund University, Lund, Sweden4 org
7730 t Multiple Sclerosis Journald : Sage Publicationsg 24:Suppl. 2, s. 696-697q 24:Suppl. 2<696-697x 1352-4585x 1477-0970
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-70214

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