MS DIGEST – Dec. 1, 2014 – Novartis today announced disappointing results for the largest clinical trial ever conducted for treatment of primary progressive multiple sclerosis (PPMS).
The INFORMS clinical trial is a Phase III clinical trial comparing the effectiveness of the drug Gilenya (fingolimod) to placebo in reducing the risk of three-month sustained disability progression based on standardized tests. The study, which began in 2008, enrolled 970 people aged 25-69 years with PPMS from 148 sites, across 18 countries.
After six years, a preliminary report on the study results showed no significant difference between the treatment group and the placebo group in reducing the risk of three-month sustained disability progression based on a composite measure of tests of disability, upper limb function, and walking speed.
Gilenya is a new class of medication that is thought to act by keeping certain white blood cells (lymphocytes) in the lymph nodes, thereby preventing those cells from crossing the blood-brain barrier into the central nervous system. Preventing the entry of these cells into the central nervous system reduces inflammatory damage to nerve cells. It was hypothesized that this central effect, which is well understood in relapsing forms of MS, might also be effective in PPMS.
PPMS is a distinct disease form, different from relapsing MS in terms of its basic disease process, near-absence of acute relapses and fewer active MRI lesions. The severe irreversible damage to the central nervous system in PPMS is thought to be caused by different pathways leading to loss of nerve cells and a more rapid, continuous loss of function over.
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