Another Disappointment for Primary Progressive MS

Approximately 10% of patients with multiple sclerosis have a slow progressive course of worsening disability without a history of attacks or relapses call primary progressive MS (PPMS).   Previous attempts to slow down the progression for this form of the disease have failed including trials with Copaxone, Novantrone and Rituxan.   Since Gilenya has direct effects on cells in the central nervous system and reduces the risk of brain atrophy,  there was hope that Gilenya might work for primary progressive MS.

The INFORMS study was a 3 year study of 970 primary progressive multiple sclerosis patients.   Patients were randomized in a double-blind study to Gilenya versus placebo in 148 clinical trial sites in 18 countries.

The primary endpoint was to evaluate the effect of fingolimod versus placebo on reducing the risk of disability progression based on a composite measure of Expanded Disability Status Scale (EDSS), assessment of upper limb function (9-Hole Peg Test), and walking speed (25-foot Timed Walk Test).

The Phase III INFORMS study in primary progressive multiple sclerosis (PPMS) did not show a significant difference between fingolimod and placebo on a combination of disability measures.