Investigators in the FREEDOMS studies enrolled 1,118 people with relapsing MS and randomized them to fingolimod or placebo for 2 years. The patients who were initially treated with placebo were then re-randomized to one of two fingolimod doses for an additional 18 months. Finally, all participants underwent treatment with the same fingolimod dose during an open-label phase. Similarly, in TRANSFORMS, researchers enrolled 1,292 people with relapsing MS and randomized them to either fingolimod or interferon beta-1a for 1 year. They then re-randomized the interferon beta-1a group to one of two fingolimod doses for a 1-year extension, then assigned all participants to one dose of fingolimod for an open-label phase.
At baseline in the FREEDOMS and FREEDOMS II studies, a longer duration of MS was associated with a higher risk for clinically definite progression or relapses at 6 months (odds ratio, 1.040), as was baseline Expanded Disability Status Scale (EDSS) score (OR, 1.229).
“In the FREEDOMS trials, what we learned is that the duration of multiple sclerosis since diagnosis and the baseline disability predict worsening between 1 and 4 years,” said Dr. Repovic, a neurologist with the Multiple Sclerosis Center at the Swedish Neuroscience Institute in Seattle.
Dr. Repovic added that “there is nothing you can do about them [the baseline predictors]. Patients are as disabled as they are, and they’ve had multiple sclerosis as long as they have.”