title: Oral fingolimod (FTY720) in relapsing multiple sclerosis: impact on health-related quality of life in a phase II study.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  Fingolimod 1.25 mg may improve HRQoL and depression at 6 months compared with placebo in patients with relapsing MS.
authors: Unitat de Neuroimmunologia Clinica, Vall d'Hebron University Hospital, Barcelona, Spain. xavier.montalban@unic-em.com
authors: X
authors: X
authors: Montalban
authors: G
authors: G
authors: Comi
authors: P
authors: P
authors: O'Connor
authors: Sm
authors: S
authors: Gold
authors: A
authors: A
authors: de Vera
authors: B
authors: B
authors: Eckert
authors: L
authors: L
authors: Kappos
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002170:Canada; D016009:Chi-Square Distribution; D003863:Depression / Q000188:drug therapy / Q000209:etiology; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D000068876:Fingolimod Hydrochloride; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D020528:Multiple Sclerosis, Chronic Progressive / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D010919:Placebos; D011409:Propylene Glycols / Q000008:administration & dosage*; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D013110:Sphingosine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010919:Placebos; D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine