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A three month interim analysis of Treatment satisfaction with Fingolimod in patients with relapsing remitting multiple sclerosis in the UK: the Patient Reported Outcomes with Fingolimod in local Experience (PROFILE) study
Objectives
The PROFILE study measured patient reported outcomes (PROs) in the real world in fingolimod treated patients with relapsing remitting multiple sclerosis (RRMS). This abstract presents interim data comparing satisfaction with previous treatment and fingolimod at three months.
Methods
A prospective observational study of 144 consenting outpatients with RRMS in 14 UK secondary care NHS centres. Eligibility: aged 18-55 years at first initiation of fingolimod (‘baseline’) and treated within the European product licence. DMT history was collected from medical records at baseline and PROs were collected at baseline, three, six, and 12 months (M). A planned interim analysis of Treatment Satisfaction Questionnaire for Medication (TSQM-9) outcomes (0-100 scale) of pre-treated patients is presented. 95% confidence intervals [CI] presented where available.
Results
Overall mean (standard deviation [SD]) TSQM-9 domain scores at 3M were: Effectiveness domain: 63.6 (19.7)[n=89]; Convenience domain: 88.2 (14.5)[n=93]; Global satisfaction domain: 65.0 (22.5)[n=94]. The mean change in domain scores from baseline were: Effectiveness domain: +14.0 [CI:7.8,20.2](n=89); Convenience domain: +32.2 [CI:27.0,37.5](n=93); Global satisfaction domain: +17.1 [CI:10.6,23.6](n=94). Mean score change from baseline to 3M across all domains improved with the number of previous DMTs received, with the exception of those receiving >2 previous DMTs in the Convenience and Global satisfaction domains, where smaller improvements in domain scores were seen. Patients switched to fingolimod from interferons or glatiramer acetate therapies had significant (p<0.05) mean changes in domain scores from baseline to 3M of: Effectiveness domain: +16.2 [CI: 9.71, 22.64](n=68); Convenience domain: +35.5 [CI:29.85,41.16](n=71); Global satisfaction domain: +17.2 [CI:9.95,24.46](n=73).
Conclusion
Overall, patients reported improved treatment satisfaction in all TSQM-9 domains after 3M of fingolimod treatment, compared to their previous treatment. These interim results suggest that patients switched to fingolimod from interferons or glatiramer acetate therapies perceive improvements in treatment convenience, effectiveness and global satisfaction.
Authors
Adlard N, Brisbane F, Watson J, Bishop-Bailey A, Kroes M
Journal
Value in Health
Therapeutic Area
Neurology
Year
2017
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