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. 2016 Sep;9(5):378-88.
doi: 10.1177/1756285616651197. Epub 2016 Jun 3.

Combination treatment of fingolimod with antidepressants in relapsing-remitting multiple sclerosis patients with depression: a multicentre, open-label study - REGAIN

Antonios Bayas  1 , Katrin Schuh  2 , Monika Baier  2 , Stefan Viktor Vormfelde  2 ; REGAIN Study Group
Collaborators, Affiliations

Combination treatment of fingolimod with antidepressants in relapsing-remitting multiple sclerosis patients with depression: a multicentre, open-label study - REGAIN

Antonios Bayas et al. Ther Adv Neurol Disord. 2016 Sep.

Abstract

Objectives: Approximately one in two patients with multiple sclerosis (MS) suffer from comorbid depression. The primary objective of this study was to evaluate the safety and tolerability of fingolimod and antidepressant combination in relapsing-remitting MS patients with mild-to-moderate depression. Efficacy outcome variables were quality of life (QoL), fatigue, disability and depression.

Methods: Patients received open-label fingolimod 0.5 mg over 2 weeks, followed by fingolimod plus citalopram (40 mg), fluoxetine (40 mg) or venlafaxine (150 mg) over 16 weeks. The antidepressant was selected at the physician's discretion.

Results: In total, 54 patients were recruited at 25 centres across Germany. No new safety signals (including cardiac) emerged compared with previous clinical studies. Adverse events (mostly mild-to-moderate) were reported in 43 patients. A total of three patients had serious adverse events and 10 discontinued the study. QoL (mean [95% confidence interval]) improved by 2.2 (-3.3, -1.2; Patient Reported Indices for MS questionnaire), fatigue by 8.2 (-13.1, -3.3; modified Fatigue Impact Scale) and depression by 6.3 (-8.4, -4.2; Hamilton Depression Scale) points. However, the results must be interpreted cautiously owing to limited patient numbers.

Conclusions: Combination of fingolimod with antidepressant medication showed no unexpected safety signals. Patient-reported outcomes (QoL, disability, fatigue and depression) remained stable or improved.

Keywords: FTY720; Gilenya®; depression; fatigue; fingolimod; multiple sclerosis.

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Conflict of interest statement

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Antonios Bayas received honoraria for consulting and/or as a speaker from Merck Serono, Germany; Biogen, Germany, Poland; Bayer Vital, Germany; Novartis, Germany, Austria; Sanofi/Genzyme, Germany, Netherlands; Roche, Germany and TEVA, Germany, for trial activities from Merck Serono, Germany; Biogen, Germany and Novartis, Germany and grants for congress trips and participation from Novartis, Germany; Biogen, Germany; Sanofi/Genzyme, Germany; and Merck Serono, Germany. Katrin Schuh, Monika Baier and Stefan Viktor Vormfelde are employees of Novartis Pharma GmbH, Nuremberg, Germany.

Figures

Figure 1.
Figure 1.
Study design. Note: Patients who had been pretreated with fingolimod for less than 14 days remained on the prescribed fingolimod until visit 2 and received fingolimod as the study medication thereafter. Patients who had been pretreated with fingolimod for at least 14 days remained on the prescribed fingolimod until visit 3 and received fingolimod as the study medication thereafter.
Figure 2.
Figure 2.
PRIMUS (QoL score), PRIMUS (activities score) and EDSS change from baseline or screening to end of study. BL, baseline; EDSS, Expanded Disability Status Scale; EOS, end of study; PRIMUS, Patient Reported Impact of Multiple Sclerosis; QoL, Quality of Life; Scr, screening.
Figure 3.
Figure 3.
BDI-II, HAM-D21 and mFIS change from baseline to end of study. BDI-II, Beck Depression Inventory Second Edition, BL, baseline; EOS, end of study; HAM-D21, Hamilton Scale for Depression; mFIS, Modified Fatigue Impact Scale.
See this image and copyright information in PMC

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