The results of a Phase III clinical trial looking at the effects of Fingolimod (Gilenya) on the inflammatory activity and tissue damage seen in MS has been published in the journal Archives of Neurology. The trial used magnetic resonance imaging (MRI) to track changes to brain lesions of people with MS and followed them over two years. 1272 people with active relapsing remitting MS participated in the trial across a number of sites worldwide.
They were split into three treatment arms, one that took the standard licenced dose of Fingolimod (0.5mg), a higher dose of 1.25 mg and a placebo (dummy tablet) group. MRI scans were taken at the start of the trial and at 6, 12 and 24 months to assess any changes to lesions in the participants.
The study found that active inflammatory and new lesions were reduced in the people taking Fingolimod, at either dose. The volume of the more permanent lesions was also reduced in the treatment groups. Tissue damage, as measured by brain volume loss, was less in both treatment groups. The differences were seen as soon as six months (the first MRI after treatment began) and were consistent across the two years of the trial. These positive changes were seen irrespective of whether lesions had been recently active, the number of lesions before the trial began, levels of disability or treatments undertaken prior to the trial.
These results suggest that fingolimod is effective in reducing not only the relapses of MS, but can also halt the ongoing damage to the brain in MS.
To read the article abstract click here
The side-effects of fingolimod are known to include cardiovascular effects, specifically slowing of the heart rate, following the initial dose. A review of fingolimod by the European Medicines Agency earlier this year has resulted in new advice on the better management of this potential adverse event. Full details can be found here