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- Ahuja, SK, et al.
(författare)
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A plea for justice for jailed medical workers
- 2006
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Ingår i: Science (New York, N.Y.). - : American Association for the Advancement of Science (AAAS). - 1095-9203 .- 0036-8075. ; 314:5801, s. 924-925
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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- Freedman, MS, et al.
(författare)
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A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis
- 2015
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Ingår i: Multiple sclerosis journal - experimental, translational and clinical. - : SAGE Publications. - 2055-2173. ; 1, s. 2055217315618687-
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Tidskriftsartikel (refereegranskat)abstract
- Teriflunomide is a once-daily oral immunomodulator for the treatment of relapsing−remitting MS. Objective To evaluate the safety and tolerability of teriflunomide as add-on therapy to a stable dose of glatiramer acetate (GA) in patients with relapsing forms of MS (RMS). Methods Phase II, randomized, double-blind, add-on, placebo-controlled study. The primary objective was to assess safety and tolerability; secondary objectives were to evaluate effects of treatment on disease activity assessed by MRI and relapse. Results Patients with RMS on GA ( N = 123) were randomized 1:1:1 to receive teriflunomide 14 mg ( n = 40), 7 mg ( n = 42), or placebo ( n = 41) for 24 weeks; 96 patients entered the 24-week extension, remaining on original treatment allocation. Teriflunomide was well tolerated over 48 weeks. The frequency of adverse events (AEs) was low across all groups; 5 (12.2%), 3 (7.1%), and 2 (5.0%) patients in the 14 mg, 7 mg, and placebo groups, respectively, discontinued treatment due to AEs. Teriflunomide reduced the number of T1-Gd lesions vs placebo (14 mg: 46.6% relative reduction, p = 0.1931; 7 mg: 64.0%: relative reduction, p = 0.0306). Conclusions Teriflunomide added to stable-dose GA had acceptable safety and tolerability, and reduced some MRI markers of disease activity compared with GA alone. NCT00475865 (core study); NCT00811395 (extension).
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- Polman, Chris H., et al.
(författare)
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Diagnostic Criteria for Multiple Sclerosis: 2010 Revisions to the McDonald Criteria
- 2011
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Ingår i: Annals of Neurology. - : Wiley. - 1531-8249 .- 0364-5134. ; 69:2, s. 292-302
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Tidskriftsartikel (refereegranskat)abstract
- New evidence and consensus has led to further revision of the McDonald Criteria for diagnosis of multiple sclerosis. The use of imaging for demonstration of dissemination of central nervous system lesions in space and time has been simplified, and in some circumstances dissemination in space and time can be established by a single scan. These revisions simplify the Criteria, preserve their diagnostic sensitivity and specificity, address their applicability across populations, and may allow earlier diagnosis and more uniform and widespread use. ANN NEUROL 2011;69:292-302
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- Wolinsky, JS, et al.
(författare)
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Magnetic resonance imaging outcomes from a phase III trial of teriflunomide
- 2013
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Ingår i: Multiple sclerosis (Houndmills, Basingstoke, England). - : SAGE Publications. - 1477-0970 .- 1352-4585. ; 19:10, s. 1310-1319
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Tidskriftsartikel (refereegranskat)abstract
- The purpose of this study was to determine the effects of oral teriflunomide on multiple sclerosis (MS) pathology inferred by magnetic resonance imaging (MRI). Methods: Patients ( n=1088) with relapsing MS were randomized to once-daily teriflunomide 7 mg or 14 mg, or placebo, for 108 weeks. MRI was recorded at baseline, 24, 48, 72 and 108 weeks. Annualized relapse rate and confirmed progression of disability (sustained ≥12 weeks) were the primary and key secondary outcomes. The principal MRI outcome was change in total lesion volume. Results: After 108 weeks, increase in total lesion volume was 67.4% ( p=0.0003) and 39.4% ( p=0.0317) lower in the 14 and 7 mg dose groups versus placebo. Other measures favoring teriflunomide were accumulated enhanced lesions, combined unique activity, T2-hyperintense and T1-hypointense component lesion volumes, white matter volume, and a composite MRI score; all were significant for teriflunomide 14 mg and most significant for 7 mg versus placebo. Conclusions: Teriflunomide provided benefits on brain MRI activity across multiple measures, with a dose effect evident on several markers. These effects were also consistent across selected subgroups of the study population. These findings complement clinical data showing significant teriflunomide-related reductions in relapse rate and disease progression, and demonstrate containment of MRI-defined disease progression.
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