title: Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study.
abstract: BACKGROUND
  Glatiramer acetate (GA) and interferon-beta (INFb) are first-line disease modifying drugs for relapsing remitting multiple sclerosis (RRMS). Treatment with INFb is associated with a significant increase in health-related quality of life (HR-QoL) in the first 12 months. It is not known whether HR-QoL increases during treatment with GA.
  
  
  METHODS
  197 RRMS patients, 106 without and 91 with prior immunomodulation/immunosuppression, were studied for HR-QoL (Leeds Multiple Sclerosis-QoL [LMS-QoL] scale, score range 0 - 32), fatigue (Fatigue Impact Scale [FIS]) and depressed mood (Beck Depression Inventory-Short Form [BDI-SF]) at baseline and 6 and 12 months after start of GA treatment.
  
  
  RESULTS
  At 6 and 12 months mean LMS-QoL scores were significantly increased in the treatment-naive patient group (p < 0.001), not in the pre-treated group. At month 12 43% of treatment-naïve patients had improved HR-QoL (increase LMS-QoL score 3 or more points) (p < 0.001). Likewise, mean FIS scores were decreased at months 6 and 12 in the treatment-naïve group (p < 0.01), not in the pre-treated group. In both groups mean BDI-SF scores did not change. No demographic or clinical baseline factor was predictive of HR-QoL increase. HR-QoL changes were zero to negative for patients who had discontinued GA before month 12 (28.4% of patients).
  
  
  CONCLUSIONS
  In RRMS patients without prior immunomodulation/immunosuppression treatment with GA was associated with an increase in HR-QoL in the first 6 months, that was sustained at 12 months. In 4 out of 10 patients HR-QoL improved. Increase in HR-QoL was associated with decrease in fatigue.
authors.affiliation: MS4 Research Institute, Ubbergseweg 34, 6522 KJ Nijmegen, the Netherlands. ms4ri@kpnmail.nl
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Jongen
authors.forename: Dirk
authors.initials: D
authors.lastname: Lehnick
authors.forename: Evert
authors.initials: E
authors.lastname: Sanders
authors.forename: Pierette
authors.initials: P
authors.lastname: Seeldrayers
authors.forename: Sten
authors.initials: S
authors.lastname: Fredrikson
authors.forename: Magnus
authors.initials: M
authors.lastname: Andersson
authors.forename: Joachim
authors.initials: J
authors.lastname: Speck
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D010455:Peptides / Q000627:therapeutic use*; D011446:Prospective Studies; D011594:Psychometrics; D036301:Qualitative Research; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate; D016899:Interferon-beta