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Impact of a switch to fingolimod on depressive symptoms in patients with relapsing multiple sclerosis: An analysis from the EPOC (Evaluate Patient OutComes) trial

Journal of the Neurological Sciences, June 2016, Pages 190 - 198

Abstract

Background

Depression is common in patients with multiple sclerosis (MS), may confound evaluation of therapeutic effectiveness and may be impacted by MS-specific treatments.

Objective

First, to assess the impact on depressive symptoms of a switch to fingolimod versus remaining on an injectable disease-modifying therapy (iDMT) in a post-hoc analysis of prospectively collected data from the EPOC study. Secondly, to investigate the underlying Beck Depression Inventory-II (BDI-II) factor structure in patients with MS, and estimate treatment differences using the resulting subscales.

Methods

EPOC was a 6-month, open-label study assessing patient-reported outcomes after switch from iDMT to oral fingolimod 0.5 mg versus remaining on iDMT in 1053 patients with relapsing–remitting MS.

Results

At end of study (EOS), a greater proportion of patients on fingolimod versus iDMT no longer had BDI-II scores indicating depression (p < 0.001). Fewer mildly and moderately symptomatic patients developed severe depressive symptoms, and fewer severely symptomatic patients continued to have scores indicating severe depression at EOS on fingolimod versus iDMT (p = 0.027, p = 0.038, p = 0.030, respectively). Two BDI-II subscales were identified and labelled Somatic and Affective; fingolimod demonstrated more reduction on both subscales at EOS versus iDMTs (p < 0.0001 and p = 0.0001, respectively).

Conclusion

A switch to fingolimod versus remaining on/switching to another iDMT was associated with an improvement in depressive symptoms in patients with relapsing–remitting MS.

Highlights

  • Multiple sclerosis (MS)-specific treatments may cause or exacerbate depression.
  • Switching therapies may therefore impact on depression in relapsing-remitting MS.
  • Injectable disease-modifying treatments (iDMT) and oral fingolimod were compared.
  • Depressive symptoms improved after switch to fingolimod vs switch to/stay on iDMT.

Keywords: BDI-II, Depression, Fingolimod, Multiple sclerosis, Patient-reported outcomes, Satisfaction.

Footnotes

a Advanced Neurosciences Institute, 101 Forrest Crossing Blvd, Suite 103, Franklin, TN 37064, USA

b Neurology Department, Barrow Neurological Institute, Phoenix AZ 85013, USA

c The Mellen Center, Cleveland Clinic Foundation, 1950 East 89th Street, Cleveland, OH 44195, USA

d University of Alabama at Birmingham, 1400 University Boulevard, Birmingham, AL 35223, USA

e Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA

f Albert Einstein College of Medicine and Montefiore Medical Center, 111 East 210th Street, Bronx, New York, NY 10467, USA

Corresponding author.

1 With the exception of one patient found subsequently to be ineligible for inclusion according to the study protocol.