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Novartis has announced new data indicating that continued treatment with Gilenya® (fingolimod) led to a reduction in brain volume loss in people with relapsing remitting multiple sclerosis (RRMS), and was associated with a higher proportion of people remaining free of disability progression compared to placebo.1 These data were presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.
Brain volume loss is emerging as a significant indicator of disability progression over the long-term in MS, and is a topic of much interest within the MS medical community.3 Loss of brain volume has been observed to occur at higher rates in patients with MS than in the general population. The average rate of brain volume loss in a person without MS over one year is 0.1% to 0.3%.4
Increasingly, research focus is on treatments that will reduce the rate of brain volume loss. Fingolimod is the only NICE recommended oral treatment for RRMS that has shown early and consistent slowing of brain volume loss,5-8 and the new data presented at ECTRIMS add to the growing evidence base for fingolimod's efficacy and reinforce the correlation between brain volume loss and disability progression over the long-term.2
Professor of Neurology, Gavin Giovannoni from Barts and the London School of Medicine and Dentistry, London, commented: "Sophisticated imaging techniques, and in a depth neuropsychological assessments, have shown that MS is characterised by progressive brain volume loss and cognitive impairment, which impact on both the social and occupational functioning of people with the disease."
The SmPC for fingolimod can be accessed here.
1. Radue E-W et al. Brain atrophy and disease-free status over 4 years: analyses of the FREEDOMS core and extension trial data. ECTRIMS 2013, Copenhagen, Denmark.
2. Barkhof F et al. Brain volume changes, on-study correlations and the link to disability in three fingolimod phase 3 studies. ECTRIMS 2013, Copenhagen, Denmark.
3. Rudick R et al. Preventing brain atrophy should be the gold standard of effective therapy in multiple sclerosis (after the first year of treatment): Commentary. Controversies in Multiple Sclerosis. Mult Scler. 2013;19(8):1007–1008.
4. Barkhof F et al. Imaging outcomes for neuroprotection and repair in multiple sclerosis trials. Nat Rev Neurol. 2009;5(5):256-266.
5. Chin PS et al.Early effect of fingolimod on clinical and MRI related outcomes in relapsing multiple sclerosis. Poster presented at: 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-13, 2012; Lyon, France. Abstract P459.
6. Cohen JA et al. Oral Fingolimod vs. intramuscular interferon in relapsing multiple sclerosis. N Eng J Med 2010; 362(5):405-415.
7. Kappos L et al. Placebo-controlled study of oral fingolimod in relapsing multiple sclerosis. N Eng J Med 2010; 362(5):387-401.
8. National Institute for Health and Clinical Excellence. Single Technology Appraisal. Fingolimod for the treatment of relapsing-remitting multiple sclerosis [ID63].
9. Radue E-W, Cohen J et al. Baseline predictors of brain atrophy in phase 3 studies of fingolimod. ECTRIMS 2013, Copenhagen, Denmark.
10. KarampampaKetal.Treatmentexperience,burdenandunmetneeds(TRIBUNE)inMSstudy:results from the United Kingdom. Mult Scler. 2012 Jun; 18(6) (Suppl 2):41-45.
11. SMCassessmentoffingolimod(ashydrochloride),0.5mghardcapsules(Gilenya).10 September 2012.
12. Novartis data on file.
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our Multiple Sclerosis category page for the latest news on this subject.
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Novartis. "New data show Gilenya® (fingolimod) reduced brain volume loss by one third and confirm link between brain volume loss and MS disability." Medical News Today. MediLexicon, Intl., 7 Oct. 2013. Web.
7 Dec. 2013. <http://www.medicalnewstoday.com/releases/267049>
Novartis. (2013, October 7). "New data show Gilenya® (fingolimod) reduced brain volume loss by one third and confirm link between brain volume loss and MS disability." Medical News Today. Retrieved from
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