title: EDSS Change Relates to Physical HRQoL While Relapse Occurrence Relates to Overall HRQoL in Patients with Multiple Sclerosis Receiving Subcutaneous Interferon β -1a.
abstract: Objective. To compare patterns of associations of changes in mental and physical health dimensions of health-related quality of life (HRQoL) over time with relapse occurrence and changes in Expanded Disability Status Scale (EDSS) scores in patients with relapsing multiple sclerosis (RMS). Methods. This 24-month, phase IV, observational study enrolled 334 patients with RMS who received interferon β-1a 44 μg or 22 μg subcutaneously three times weekly. At each 6-month visit, patients completed the Multiple Sclerosis Quality of Life-54 (MSQOL-54) and site investigators assessed EDSS and recorded relapse occurrence. A generalized linear model procedure was used for multivariable analyses (per protocol) that explored unique associations of EDSS score change and relapse occurrence with MSQOL-54 physical health composite score (PCS) and mental health composite score (MCS). Results. HRQoL improved over 2 years among those who completed the study. Occurrence of ≥1 relapse was significantly associated with lower MSQOL-54 PCS and MCS. Changes in EDSS score were significantly associated with MSQOL-54 PCS, but not MCS. Conclusions. HRQoL assessments, particularly those that examine mental health, may provide information on the general health status of patients with RMS that would not be recognized using traditional clinician-assessed measures of disease severity and activity. This trial is registered with ClinicalTrials.gov; identifier: NCT01141751.
authors.affiliation: Department of Neurology, University of California, Los Angeles, 710 Westwood Plaza, Los Angeles, CA 90095-1796, USA ; Greater Los Angeles VA Medical Center, 11301 Wilshire Boulevard, Los Angeles, CA 90073, USA.
authors.forename: Barbara G
authors.initials: BG
authors.lastname: Vickrey
authors.affiliation: Division of Neurology, University of Toronto, Sunnybrook Health Science Center, 2075 Bayview Avenue, Toronto, ON, Canada M4N 3M5.
authors.forename: Liesly
authors.initials: L
authors.lastname: Lee
authors.affiliation: Department of Neurology, Jewish General Hospital, McGill University, 3755 Côte-Sainte-Catherine Road, Montreal, QC, Canada H3T 1E2.
authors.forename: Fraser
authors.initials: F
authors.lastname: Moore
authors.affiliation: Department of Medical Affairs, EMD Serono, 2695 North Sheridan Way, Suite 200, Mississauga, ON, Canada L5K 2N6.
authors.forename: Patrick
authors.initials: P
authors.lastname: Moriarty