Gilenya fails in primary progressive multiple sclerosis trial

December 29, 2014 Pavle Repovic, MD, PhD

We recently found out that Gilenya (fingolimod), an oral treatment for relapsing multiple sclerosis (MS), did not slow down disability progression in a phase III trial among primary progressive MS (PPMS) patients. The trial, called INFORMS, was the largest to date in PPMS, involving 970 patients in North America, Europe, and Australia. Patients were assigned to placebo or Gilenya for 3 years, and the primary outcome was a composite of walking, arm function and overall disability measures. Unfortunately, the progression rates in Gilenya and placebo groups were not statistically different. A full report of the trial will be presented at one of the upcoming neurology meetings, possibly in April 2015.

With this news, Gilenya joins Copaxone (glatiramer acetate) and interferons in the lineup of medications that, while effective for relapsing MS, fail to slow down disability among patients with progressive MS. Much hope had been pinned to the Gilenya study, in part due to its well-documented ability to reduce brain atrophy.

Several points remain unclear at this point and will hopefully be addressed when full results are presented. You can expect to see subgroup analyses, where certain populations might have benefited from Gilenya. This was the case with Copaxone trial in PPMS (OLYMPUS trial), that was also unsuccessful, but showed that men did benefit somewhat from the intervention. It is important to remember, however, that subgroup analyses are generally less valid than primary outcome analysis.

Fortunately, a number of other trials and initiatives targeting progressive MS are underway, due in part to the emphasis placed on this MS subtype by the National MS Society.

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