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Fingolimod (Gilenya) Reduces Brain Volume Loss in MS Patients

New data presented at European congress (October 4)

In new study data, continued treatment with fingolimod (Gilenya, Novartis) led to a reduction in brain volume loss in patients with relapsing forms of multiple sclerosis (MS) and was associated with a higher proportion of patients remaining free of disability progression. The new data were presented at the ongoing 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.

Key findings include the following:

  • Collective 4-year results from the pivotal FREEDOMS and FREEDOMS extension studies showed that patients who were treated continuously with fingolimod 0.5 mg experienced up to one-third less brain volume loss than did patients who switched to fingolimod after receiving placebo for 2 years.
  • Overall, patients who remained free of disease had consistently lower rates of brain volume loss compared with patients who experienced disease activity and MS progression. However, the benefit of fingolimod on brain volume loss was seen irrespective of whether patients were disease-free or had active disease.
  • A separate analysis of three key studies (FREEDOMS, FREEDOMS II, and TRANFORMS) showed a correlation between disability progression and increased brain volume loss, and this correlation increased over time.
  • Higher baseline magnetic resonance imaging (MRI) lesion volume and baseline active lesions both predicted subsequent loss of brain volume during the studies, but patients treated with fingolimod had less brain volume loss than had those treated with placebo or intramuscular interferon-beta 1a, irrespective of baseline lesion volume and count.
  • MS patients with higher brain volume loss were more likely to experience disability progression.

Gilenya (fingolimod) is the first oral therapy approved to treat relapsing forms of MS and is the first in a new class of compounds called sphingosine-1 phosphate receptor modulators.

Source: Novartis; October 4, 2013.

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