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A Swedish Nationwid...
A Swedish Nationwide study of the long-term effectiveness and safety of teriflunomid based on data from the Swedish "Immunomodulation and Multiple Sclerosis Epidemiology" Study (IMSE 4)
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- Forsberg, L. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Kågström, S. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Fält, A. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Hillert, J. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Nilsson, P. (författare)
- Department of Neurology, Lund University, Lund, Sweden
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- Dahle, C. (författare)
- Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden
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- Svenningsson, A. (författare)
- Department of Clinical Science, Danderyd Hospital, Stockholm, Sweden
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- Lycke, J. (författare)
- Department of Clinical Neuroscience and Rehabilitation, University of Gothenburg, Gothenburg, Sweden
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- Landtblom, A. -M (författare)
- Department of Neuroscience, Uppsala University, Uppsala, Sweden
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- Burman, J. (författare)
- Department of Neuroscience, Uppsala University, Uppsala, Sweden
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- Martin, C. (författare)
- Department of Clinical Science, Danderyd Hospital, Stockholm, Sweden
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- Sundström, P. (författare)
- Department of Clinical Neuroscience, Umeå University, Umeå, Sweden
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- Gunnarsson, Martin, 1973- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Department of Neurology
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- Piehl, F. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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- Olsson, T. (författare)
- Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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(creator_code:org_t)
- Sage Publications, 2019
- 2019
- Engelska.
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Ingår i: Multiple Sclerosis Journal. - : Sage Publications. - 1352-4585 .- 1477-0970. ; 25:Suppl. 2, s. 316-316
- Relaterad länk:
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https://urn.kb.se/re...
Abstract
Ämnesord
Stäng
- Background: Teriflunomid (TFM) is a newly approved oral therapy for relapsing-remitting multiple sclerosis (RRMS), which has been included in the Swedish post-market surveillance study “Immunomodulation and Multiple Sclerosis Epidemiology” (IMSE) in order to track the long-term safety and effectiveness in a real-world setting.Objectives: To track the long-term safety and effectiveness of TFM in a real-world setting.Methods: A large majority of MS patients are registered into the nationwide Swedish Neuro Registry (NeuroReg). The IMSE 4 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.Results: A total of 559 TFM-treated patients had been included in the IMSE 4 study from March 2014 to March 2019. 71 % were female and the mean age at treatment start was 46 years. The mean treatment duration was 23 months and 89 % of the patients had RRMS (9 % missing data on MS phenotype). Most patients switched from interferon/glatiramer acetate (36 %) and 16 % of the patients were treatment naïve before starting TFM. The overall one-year drug survival rate was 74 % and the overall two-year drug survival rate was 58 %. 232 (42 %) patients had terminated their treatment at some point, of which 46 % started rituximab treatment and 12 % had no new treatment registered. The most common reasons for discontinuation were AEs (41 %) and lack of effect (39 %). 229 patients had been continuously treated with TFM for ⩾24 months and significant changes in mean baseline values compared to values at 24 months were noted for EDSS (1.9 ± 1.5 to 2.1 ± 1.6, n=66) and SDMT (50.3 ± 10.5 to 52.3 ± 13.0, n=88). A total of 34 AEs were reported to the Swedish Medical Products Agency of which 9 events were classified as serious, none fatal.Conclusions: NeuroReg proves to function well as a post-marketing drug surveillance platform, providing data regarding drug effectiveness and AEs. Patients starting TMF are older at treat-ment start than most other DMTs, which may explain the lack of improvement in EDSS scores. Still, a relatively high proportion switched due to lack of effect. A longer follow-up period is needed to assess the real-world effectiveness and safety of TMF.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
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Forsberg, L.
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Kågström, S.
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Fält, A.
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Hillert, J.
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Nilsson, P.
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Dahle, C.
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visa fler...
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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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