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Oral fingolimod (FTY720) in relapsing multiple sclerosis: impact on health-related quality of life in a phase II study
Journal article

Oral fingolimod (FTY720) in relapsing multiple sclerosis: impact on health-related quality of life in a phase II study

  • Montalban, X Unitat de Neuroimmunologia Clinica, Vall d’Hebron University Hospital, Barcelona, Spain.
  • Comi, G Department of Neurology, Università Vita–Salute San Raffaele, Milan, Italy.
  • O’Connor, P St Michael’s Hospital, Toronto, ON, Canada.
  • Gold, SM Department of Neurology, University of California Los Angeles, Los Angeles, CA, USA.
  • de Vera, A Clinical Development and Medical Affairs-Neuroscience, Novartis Pharma AG, Basel, Switzerland.
  • Eckert, B Global Health Economics and Outcomes Research, Novartis Pharma AG, Basel, Switzerland.
  • Kappos, L Neurology and Department of Biomedicine, University Hospital, Basel, Switzerland.
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  • 2011-7-4
Published in:
  • Multiple Sclerosis Journal. - SAGE Publications. - 2011, vol. 17, no. 11, p. 1341-1350
Neurology
Clinical Neurology
English 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.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://folia.unifr.ch/global/documents/195059
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