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

2011 ◽  
Vol 17 (11) ◽  
pp. 1341-1350 ◽  
Author(s):  
X Montalban ◽  
G Comi ◽  
P O’Connor ◽  
SM Gold ◽  
A de Vera ◽  
...  

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.

2020 ◽  
pp. 0000-0000
Author(s):  
Ricardo N. Alonso ◽  
Maria B. Eizaguirre ◽  
Leila Cohen ◽  
Cecilia Quarracino ◽  
Berenice Silva ◽  
...  

Abstract Background: Scales to assess disability in multiple sclerosis (MS) rarely provides reliable data on the actual global impairment. Upper limbs (UL) dysfunction is usually overlooked, which has a negative impact on the patient's well-being. Objectives: 1) to analyze the association between UL dexterity, lower limbs (LL) speed and the EDSS score. 2) To analyze the difference in UL dexterity between patients with EDSS &lt;5 and ≥5. 3) To study the association that UL dexterity, LL speed and the EDSS score have with both health-related quality of life measurements and depression. Methods: Our sample included 140 adults with MS. They were evaluated using the Nine-Hole Peg Test, the Timed 25-Foot Walk test, the EDSS, the Multiple Sclerosis International Quality of Life questionnaire (MusiQol), and the Beck Depression Inventory. We conducted a thorough descriptive-analytical research using Spearman's correlation, multiple linear regression and structural equation modeling. Results: UL dexterity was more closely related to the EDSS than LL speed (r: 0.43 vs. 0.29, R2: 0.38). UL dexterity was greatest in patients with EDSS &lt;5 (P &lt; .001). Moreover, UL dexterity was negatively associated with EDSS and the MusiQol (rS: between −0.557 and −0.358, P &lt; .05). The correlation that depression has with loss of dexterity in UL was higher than the one it has with LL speed (0.098 vs 0.066, t &gt; 1.96). Conclusions: UL dexterity is associated and global disability, depression, and health-related quality of life. We advocate for the assessment of UL dexterity during MS patients' consultations to adopt a better approach to their functional impairment.


2009 ◽  
Vol 15 (10) ◽  
pp. 1239-1249 ◽  
Author(s):  
JM Wesson ◽  
JA Cooper ◽  
LS Jehle ◽  
SN Lockhart ◽  
K. Draney ◽  
...  

Addressing health-related quality of life is considered a desirable component of routine care for patients with multiple sclerosis. However, use of available health-related quality of life surveys is not part of routine multiple sclerosis care, possibly due to administration, scoring, and interpretation challenges presented by available questionnaires. The 25-item Functional Index for Living with Multiple Sclerosis (FILMS) questionnaire was developed and validated to allow providers to monitor and easily apply health-related quality of life information to the patient encounter. The development and pilot test processes and the results of the validation study are reported here. Convergent validity, internal consistency reliability, and test—retest reproducibility were evaluated. Strong correlations of Functional Index for Living with Multiple Sclerosis subscales with control questionnaires were demonstrated by Pearson’s correlation coefficients from 0.73 to 0.88. Internal consistency reliabilities ranged from 0.80 to 0.90, demonstrating that items were grouped into the appropriate subscale domains and that the subscale domains and the questionnaire as a whole exhibited good directionality. Test—retest reproducibility was 0.91.


2010 ◽  
Vol 12 (2) ◽  
pp. 83-91 ◽  
Author(s):  
Vivek S. Pawar ◽  
Gauri Pawar ◽  
Lesley-Ann Miller ◽  
Iftekhar Kalsekar ◽  
Jan Kavookjian ◽  
...  

The aim of this study was to evaluate the impact of visual impairment on health-related quality of life (HRQOL) in patients with multiple sclerosis (MS). Patients at an outpatient MS clinic were asked to complete a battery of patient-reported outcome questionnaires. Health-related quality of life was measured using the Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS), while visual impairment was measured using the Visual Function Questionnaire (VFQ). Hierarchical regression was used to determine the relative contribution of visual impairment to HRQOL. Usable responses were obtained for 116 MS patients. Those with higher levels of visual impairment (lower scores on the VFQ) reported significantly lower HRQOL (β = –0.01, P = .0007). Visual impairment also explained an additional 4% variance in the HRQOL scores, independent of disability and depression (ΔR2 = 0.04, F7,108 = 36.58). Overall, disability was the strongest predictor of HRQOL, explaining over 60% of the variation in HRQOL scores. The model explained 70% of the total variance in HRQOL. Given the prevalence of visual impairment and its influence on overall HRQOL, MS patients should be routinely screened using standard ophthalmic examination procedures or self-administered questionnaires such as the VFQ.


2008 ◽  
Vol 47 (5) ◽  
pp. 843-851 ◽  
Author(s):  
Peter C. Trask ◽  
Andrew G. Bushmakin ◽  
Joseph C. Cappelleri ◽  
Paul Bycott ◽  
Katherine Liau ◽  
...  

2009 ◽  
Vol 100 (3) ◽  
pp. 148-155 ◽  
Author(s):  
L. E. M. A. Pfennings ◽  
H. M. Ploeg ◽  
L. Cohen ◽  
I. Bramsen ◽  
C. H. Polman ◽  
...  

2007 ◽  
Author(s):  
Laura E. Dreer ◽  
G. McGwin ◽  
K. Scilley ◽  
G. C. Meek ◽  
A. Dyer ◽  
...  

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