title: Impact of a switch to fingolimod on depressive symptoms in patients with relapsing multiple sclerosis: An analysis from the EPOC (Evaluate Patient OutComes) trial.
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 0.5mg 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Advanced Neurosciences Institute, 101 Forrest Crossing Blvd, Suite 103, Franklin, TN 37064, USA. Electronic address: sfhunter@neurosci.us.
authors.forename: Samuel F
authors.initials: SF
authors.lastname: Hunter
authors.affiliation: Neurology Department, Barrow Neurological Institute, Phoenix AZ 85013, USA. Electronic address: markaagius@hotmail.com.
authors.forename: Mark
authors.initials: M
authors.lastname: Agius
authors.affiliation: The Mellen Center, Cleveland Clinic Foundation, 1950 East 89th Street, Cleveland, OH 44195, USA. Electronic address: millerd@ccf.org.
authors.forename: Deborah M
authors.initials: DM
authors.lastname: Miller
authors.affiliation: University of Alabama at Birmingham, 1400 University Boulevard, Birmingham, AL 35223, USA. Electronic address: cutterg@uab.edu.
authors.forename: Gary
authors.initials: G
authors.lastname: Cutter
authors.affiliation: Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: Luigi.barbato@abbvie.com.
authors.forename: Luigi
authors.initials: L
authors.lastname: Barbato
authors.affiliation: Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: kevin.mccague@novartis.com.
authors.forename: Kevin
authors.initials: K
authors.lastname: McCague
authors.affiliation: Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: Xiangyi.meng@novartis.com.
authors.forename: Xiangyi
authors.initials: X
authors.lastname: Meng
authors.affiliation: Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: neetu.agashivala@novartis.com.
authors.forename: Neetu
authors.initials: N
authors.lastname: Agashivala
authors.affiliation: Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: neuroepi@yahoo.com.
authors.forename: Peter
authors.initials: P
authors.lastname: Chin
authors.affiliation: Albert Einstein College of Medicine and Montefiore Medical Center, 111 East 210th Street, Bronx, New York, NY 10467, USA. Electronic address: eholland@montefiore.org.
authors.forename: Eric
authors.initials: E
authors.lastname: Hollander
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003866:Depressive Disorder / Q000188:drug therapy* / Q000209:etiology*; D004185:Disability Evaluation; D004333:Drug Administration Routes; D057915:Drug Substitution; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000150:complications* / Q000188:drug therapy; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride
keywords: BDI-II; Depression; Fingolimod; Multiple sclerosis; Patient-reported outcomes; Satisfaction