Gilenya data links brain shrinkage with disability risk in MS patients- Novartis

. Novartis has announced that new data presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, reinforces the clinical importance of measuring brain shrinkage (brain volume loss) in Multiple Sclerosis (MS). An association between the rate of brain shrinkage and increased risk of long-term disability progression was confirmed in patients with MS.

In pooled data from the phase III FREEDOMS core and extension studies, patients were categorized into four groups (quartiles) based on the mean change in brain volume from the start of the study to year-two. The analysis showed that 24.2% of patients who had the highest rate of brain shrinkage at 2 years had confirmed six-month disability progression at four years, compared to 15.4% of patients with the lowest rate of brain shrinkage (p=0.018). A separate analysis from the long-term follow-up extension study LONGTERMS, showed that the rate of brain shrinkage in patients treated with Gilenya� (fingolimod) remained similar throughout the six-year period, between 0.33% and 0.46%. This was broadly in the range you would expect to see in people without MS, while the typical rate of brain shrinkage experienced by patients with MS is approximately 0.5% to 1.35% per year.

The rate of brain shrinkage for people with MS is around three to five times faster than people without the disease, and what is lost cannot be recovered. Brain shrinkage can start early, often goes unnoticed and is associated with a loss of physical and cognitive (i.e. memory) function for patients with MS.