The TRANSFORMS trial [Cohen JA et al. N Engl J Med. 2010] randomized 1292 patients with relapsing multiple sclerosis with a recent history of ≥ 1 relapse to oral fingolimod 1.25 or 0.5 mg or intramuscular interferon beta-1a (IFN-β-1a) 30 μg weekly. At 12 months, patients who received fingolimod had a significantly lower annualized relapse rate than the group who received IFN-β-1a (P < .001 for both doses of fingolimod vs IFN-β-1a).

In the TRANSFORMS extension trial [NCT00340834], 1030 patients who were randomly assigned to receive either dose of fingolimod continued on that same dose. Patients who were originally randomized to IFN-β-1a were now randomly reassigned to fingolimod 0.5 or 1.25 mg. The efficacy end points were annualized relapse rate, disability progression, and magnetic resonance imaging (MRI) outcomes [Khatri B et al. Lancet Neurol. 2011]. Patients who took fingolimod throughout 24 months (TRANSFORMS plus extension) showed a sustained improvement in clinical and MRI outcomes. Patients who switched from IFN-β-1a to fingolimod at 12 months experienced improvements in relapse rate and MRI findings compared with the previous 12 months.

Pavle Repovic, MD, PhD, Swedish Neuroscience Institute, Seattle, Washington, USA, presented 2 post hoc analyses in a poster using data from TRANSFORMS and the extension trial. The goal of these analyses was to determine whether year 1 MRI results and relapse rates could predict relapses or 6-month confirmed disability progression, measured by Expanded Disability Severity Scale over the following 36 months in the TRANSFORMS extension. An additional analysis explored outcomes at 24 months following the switch from IFN-β-1a to fingolimod at 12 months.

According to unadjusted logistic regression, significant predictors (P < .01) for either relapses or 6-month confirmed disability progression were MRI activity in year 1, relapses in year 1, and combined MRI activity and relapses in year 1.

The proportion of patients with MRI activity and relapses from baseline to month 12 was 12.9% for IFN-β-1a and 4.9% for fingolimod 0.5 mg. At months 12 to 24, the proportion remained low (3.2%) for continuous fingolimod. When patients were switched from IFN-β-1a to fingolimod, the proportion of patients with MRI activity and relapses decreased to 3.9%, which represented a 70% reduction (P = .0014).

In conclusion, MRI activity and relapses during year 1 were predictors of later clinical outcomes. Switching from IFN-β-1a to fingolimod after year 1 reduced the proportion of patients experiencing MRI activity and relapses, which may be associated with improved long-term outcomes.