期刊
MULTIPLE SCLEROSIS JOURNAL
卷 17, 期 11, 页码 1341-1350出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/1352458511411061
关键词
BDI-II; depression; fingolimod; FTY720; HAQUAMS; HRQoL
资金
- Novartis Pharma AG, Basel, Switzerland
- Actelion
- Biogen Idec.
- Celgene
- Sanofi-Aventis
- EMD Serono
- Abbott Labs
- Teva Pharmaceuticals
- Bayer
- Bio MS
- Genentech
- Lilly
- Roche
- Novartis
- MS Society of Canada
- NIH
- Direct MS
Background: Health-related quality of life (HRQoL) worsens with multiple sclerosis (MS) relapses and disease progression. Common symptoms including depression and fatigue may contribute to poor HRQoL. Objectives: To report exploratory analyses assessing the impact of fingolimod (FTY720) on HRQoL and depression in a phase II study of relapsing MS. Methods: The Hamburg Quality of Life Questionnaire in MS (HAQUAMS) and Beck Depression Inventory second edition (BDI-II) scores were assessed during a 6-month, placebo-controlled study and optional extension. Results: HAQUAMS total score improved with fingolimod and worsened with placebo. Mean score change from baseline to month 6 was -0.02 with fingolimod 1.25 mg (p < 0.05 versus placebo), -0.01 with fingolimod 5.0 mg and +0.12 with placebo. Categorical data supported a clinically important effect of fingolimod on HRQoL. Fingolimod 1.25 mg was also beneficial over placebo in the fatigue/thinking HAQUAMS sub-domain (p < 0.05 versus placebo). Change in mean BDI-II scores from baseline to month 6 and the proportion of patients with BDI-II scores indicative of clinical depression favored fingolimod 1.25 mg over placebo (p < 0.05 for both). At month 4, mean BDI-II and HAQUAMS total scores appeared to be maintained in fingolimod-treated patients. Conclusion: Fingolimod 1.25 mg may improve HRQoL and depression at 6 onths compared with placebo in patients with relapsing MS.
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