Phase IV study of retention on fingolimod versus injectable multiple sclerosis therapies: a randomized clinical trial

Therapeutic Advances in Neurological Disorders
Bruce CreeNadia Tenenbaum

Abstract

In relapsing-remitting multiple sclerosis (RRMS), suboptimal adherence to injectable disease-modifying therapies (iDMTs; interferon β-1a/b, glatiramer acetate) is common, reducing their effectiveness. Patient retention on oral fingolimod and iDMTs was evaluated in PREFERMS, a randomized, parallel-group, active-controlled, open-label, 48-week study. Patients were included if they had RRMS, were aged 18-65 years and had Expanded Disability Status Scale score up to 6, enrolled at 117 US study sites, were treatment naïve or had received only one iDMT class. Patients were randomized 1:1 (fingolimod 0.5 mg/day; preselected iDMT) by interactive voice-and-web-response system without blinding, followed up quarterly, and allowed one study-approved treatment switch after 12 weeks, or earlier for efficacy or safety reasons. The primary outcome was patient retention on randomized treatment over 48 weeks. Secondary endpoints included patient-reported outcomes, brain volume loss (BVL), and cognitive function. Analysis of 433/436 patients receiving fingolimod and 428/439 receiving iDMTs showed that patient retention rate was significantly higher with fingolimod than with iDMTs [352 (81.3%) versus 125 (29.2%); 95% confidence interval 46.4-57.8%...Continue Reading

References

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Citations

Dec 24, 2019·British Journal of Clinical Pharmacology·Ting YangYi-Min Cui
Sep 13, 2019·Neurology. Neuroimmunology and Neuroinflammation·Edward J FoxBruce A C Cree
Apr 25, 2020·Multivariate Behavioral Research·Christoph Kiefer, Axel Mayer
Feb 2, 2021·Neurodegenerative Disease Management·Augusto A MiravalleEdward J Fox
Mar 6, 2021·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Juan S LasaLaurent Peyrin-Biroulet
Aug 26, 2021·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·Dawn W LangdonLudwig Kappos

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