Samuel F Hunter1, Mark Agius2, Deborah M Miller3, Gary Cutter4, Luigi Barbato5, Kevin McCague6, Xiangyi Meng7, Neetu Agashivala8, Peter Chin9, Eric Hollander10. 1. Advanced Neurosciences Institute, 101 Forrest Crossing Blvd, Suite 103, Franklin, TN 37064, USA. Electronic address: sfhunter@neurosci.us. 2. Neurology Department, Barrow Neurological Institute, Phoenix AZ 85013, USA. Electronic address: markaagius@hotmail.com. 3. The Mellen Center, Cleveland Clinic Foundation, 1950 East 89th Street, Cleveland, OH 44195, USA. Electronic address: millerd@ccf.org. 4. University of Alabama at Birmingham, 1400 University Boulevard, Birmingham, AL 35223, USA. Electronic address: cutterg@uab.edu. 5. Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: Luigi.barbato@abbvie.com. 6. Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: kevin.mccague@novartis.com. 7. Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: Xiangyi.meng@novartis.com. 8. Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: neetu.agashivala@novartis.com. 9. Novartis Pharmaceuticals Corporation, 1 Health Plz, East Hanover, NJ 07936, USA. Electronic address: neuroepi@yahoo.com. 10. Albert Einstein College of Medicine and Montefiore Medical Center, 111 East 210th Street, Bronx, New York, NY 10467, USA. Electronic address: eholland@montefiore.org.
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). 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.
RCT Entities:
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). 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.
Authors: Florian M Ottenlinger; Christoph A Mayer; Nerea Ferreirós; Yannick Schreiber; Anja Schwiebs; Katrin G Schmidt; Hanns Ackermann; Josef M Pfeilschifter; Heinfried H Radeke Journal: Front Pharmacol Date: 2016-11-03 Impact factor: 5.810
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