Background: The Evaluate Patient OutComes (ClinicalTrials.gov Identifier: NCT01216072) study was conducted in North America to assess MSer- and physician-reported treatment satisfaction in MSers with relapsing multiple sclerosis (MS) who received oral fingolimod for 6 months after switching from an injectable disease-modifying therapy (iDMT), without an intervening washout.
Methods: In this open-label, multicenter study, MSers were randomized 3:1 to once-daily fingolimod 0.5 mg or iDMT. The primary study objective was to evaluate differences in satisfaction measured using the Treatment Satisfaction Questionnaire for Medication v1.4.
Results: Of 1053 MSers randomized, 790 MSers received fingolimod and 263 MSers received iDMT. Treatment satisfaction improved significantly in MSers who switched to fingolimod compared with those who continued iDMT. MSers also reported significant improvements in health-related quality of life, reduced depression, and reduced fatigue severity after a switch to fingolimod. No difference between the treatment groups was detected on the Patient Reported Indices for MS Activities scale. The safety profile of fingolimod was consistent with that reported in the pivotal phase 3 studies. The most commonly reported adverse events were more prevalent in MSers who switched to fingolimod than in those who continued iDMT (headache: 12% vs 3%; fatigue: 12% vs 6%). No significant relationship between lymphocyte counts and infection rates was observed and there was no evidence of additive immune-system effects, which might be expected when switching to a different class of immunomodulatory therapy with no intervening washout.
Conclusion: MSers who switched from iDMT to fingolimod had significant improvements in most self-reported outcomes compared with those who continued iDMT.