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- Kappos, L., et al.
(författare)
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Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS
- 2006
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Ingår i: Neurology. - 1526-632X. ; 67:6, s. 944-953
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To conduct systematic long-term follow-up (LTFU) of patients in the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis ( PRISMS) study to provide up to 8 years of safety, clinical and MRI outcomes on subcutaneous (SC) interferon (IFN) beta-1a in relapsing-remitting multiple sclerosis (RRMS). Methods: The original cohort of 560 patients was randomized to IFN beta-1a, 44 or 22 mu g three times weekly (TIW) or to placebo; after 2 years, patients on placebo were rerandomized to active treatment and the blinded study continued for a further 4 years. The LTFU visit was scheduled 7 to 8 years after baseline. Results: LTFU was attended by 68.2% of the original PRISMS study cohort ( 382/560 patients). 72.0% (275/382) were still receiving IFN beta-1a SC TIW. Patients originally randomized to IFN beta-1a 44 mu g SC TIW showed lower Expanded Disability Status Scale progression, relapse rate and T2 burden of disease up to 8 years compared with those in the late treatment group. Brain parenchymal volume did not show differences by treatment group. Overall, 19.7% of patients progressed to secondary progressive MS between baseline and LTFU (75/381). No new safety concerns were identified and treatment was generally well tolerated. Conclusions: Despite the limitations inherent in any long-term study ( for example, potential differences between returning and nonreturning patients), these results indicate that patients with relapsing-remitting multiple sclerosis can experience sustained benefit over many years from early interferon beta-1a subcutaneous therapy three times weekly compared with patients whose treatment is delayed. This effect was more apparent in the patients receiving the higher dose.
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- Petzold, A., et al.
(författare)
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Biomarker time out
- 2014
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Ingår i: Multiple Sclerosis Journal. - : SAGE Publications. - 1352-4585 .- 1477-0970. ; 20:12, s. 1560-1563
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Tidskriftsartikel (refereegranskat)abstract
- The advancement of knowledge relies on scientific investigations. The timing between asking a question and data collection defines if a study is prospective or retrospective. Prospective studies look forward from a point in time, are less prone to bias and are considered superior to retrospective studies. This conceptual framework conflicts with the nature of biomarker research. New candidate biomarkers are discovered in a retrospective manner. There are neither resources nor time for prospective testing in all cases. Relevant sources for bias are not covered. Ethical questions arise through the time penalty of an overly dogmatic concept. The timing of sample collection can be separated from testing biomarkers. Therefore the moment of formulating a hypothesis may be after sample collection was completed. A conceptual framework permissive to asking research questions without the obligation to bow to the human concept of calendar time would simplify biomarker research, but will require new safeguards against bias.
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