Highlights
- •The phase 4 Evaluate Patient OutComes study was conducted in North America.
- •Patients switched directly from an injectable DMT to fingolimod without a washout.
- •Most self-reported outcomes significantly improved 6 months after the switch.
- •The EPOC study broadens knowledge of fingolimod use in a real-world scenario.
Abstract
Background
The Evaluate Patient OutComes (ClinicalTrials.gov Identifier: NCT01216072) study was
conducted in North America to assess patient- and physician-reported treatment satisfaction
in patients 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, patients 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 patients randomized, 790 patients received fingolimod and 263 patients received
iDMT. Treatment satisfaction improved significantly in patients who switched to fingolimod
compared with those who continued iDMT. Patients 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 patients 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
Patients who switched from iDMT to fingolimod had significant improvements in most
self-reported outcomes compared with those who continued iDMT.
Keywords
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Publication history
Published online: July 03, 2014
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© 2014 Elsevier B.V. Published by Elsevier Inc. All rights reserved.
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- First-dose effects of fingolimod after switching from injectable therapies in the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosisMultiple Sclerosis and Related DisordersVol. 3Issue 5
