Sökning: id:"swepub:oai:DiVA.org:oru-70218" >
A Swedish nationwid...
A Swedish nationwide pharmaco-epidemiological study of the long-term safety and effectiveness of teriflunomid (IMSE 4)
-
- 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
-
visa fler...
-
- 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
-
visa färre...
-
(creator_code:org_t)
- Sage Publications, 2018
- 2018
- Engelska.
-
Ingår i: Multiple Sclerosis Journal. - : Sage Publications. - 1352-4585 .- 1477-0970. ; 24:Suppl. 2, s. 922-923
- Relaterad länk:
-
https://urn.kb.se/re...
Abstract
Ämnesord
Stäng
- Background: Teriflunomid (TFM) 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 4” (IMSE 4) in order to surveille and determine the long-term safety and effectiveness in a real-world setting.Objectives: To follow-up the long-term safety and effectiveness of TFM in a real-world setting.Methods: MS patients are registered into the nationwide Swedish Neuro Registry (NeuroReg) in Sweden. 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: 481 TFM-treated patients have been included in the IMSE 4 study between March 2014 and April 2018. 70 % were female and the mean age at treatment start was 45.8 years. The mean treatment duration was 20.5 months. 89 % of the patients had RRMS with 3 % missing data on MS phenotype. Most patients switched from interferon and glatimer acetat (37 %) and 14 % of the patients were treatment naïve before starting TFM. The overall one year drug survival rate was 81 % and the overall two year drug survival rate was 41 %. 168 (35 %) patients terminated their treatment at some point, of which 33 % started rituximab treatment and 22 % have no new treatment registered. The most common reasons for discontinuation were AEs (49 %) and lack of effect (40 %). 318 patients have been continuously treated with TFM for ≥12 months and mean baseline values compared to val-ues at 12 months have been noted for EDSS (2.0 ± 1.5 to 2.2 ± 1.5, n=141); MSSS (2.6 ± 2.2 to 2.9 ± 2.3, n=126); SDMT (50.8 ± 10.5 to 50.8 ± 10.7, n=165); MSIS-29 Physiological subscale (20.2 ± 19.3 to 19.7 ± 20.0, n=181); MSIS-29 Psychological subscale (28.1 ± 22.2 to 23.7 ± 21.7, n=181); EQ-5D (0.74 ± 0.24 to 0.73 ± 0.26, n=154); and VAS (70.0 ± 20.8 to 70.8 ± 19.6, n=150).Conclusions: NeuroReg proves to function well as a post-marketing drug surveillance platform, providing data regarding drug effectiveness and AEs. However, 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)
Publikations- och innehållstyp
- vet (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Demirbüker, S. S ...
-
Kågström, S.
-
Fält, A.
-
Hillert, J.
-
Nilsson, P.
-
Dahle, C.
-
visa fler...
-
Svenningsson, A.
-
Lycke, J.
-
Landtblom, A. -M
-
Burman, J.
-
Sundström, P.
-
Martin, C.
-
Gunnarsson, Mart ...
-
Piehl, F.
-
Olsson, T.
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Neurologi
- Artiklar i publikationen
-
Multiple Scleros ...
- Av lärosätet
-
Örebro universitet