Abstract Details

Title Patient-Reported Treatment Satisfaction, Reasons for Therapy Change, and Health-Related Quality of Life at Baseline from the Trial To Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (EPOC)

Topic MS and Related Diseases

Presentation(s) P03 - (-)

Poster/Presentation
Number 222

Objective

Background BACKGROUND: Data regarding treatment satisfaction among patients with multiple sclerosis (MS) seeking a change in disease-modifying therapy (DMT) are scant.

Design/Methods DESIGN/METHODS: Eligible patients for this phase 4 study had relapsing MS and had received ?6 months' continuous treatment with a standard DMT before randomization to open-label fingolimod 0.5 mg or standard DMT. Reasons for therapy change and scores on the following PRO instruments were collected prior to randomization: global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication v1.4 (TSQM; range of possible scores, 0-100); TSQM effectiveness, side effects and convenience subscales; Short Form Health Survey v2 standard (SF-36 v2; health-related quality of life; range of possible scores, 0-100); Patient-Reported Indices for MS scale (PRIMUS-Activities; activities of daily living; range 0-30); Fatigue Severity Scale (FSS; range 1-7); Beck Depression Inventory-II (BDI-II; range 0-63).

Results RESULTS: DMTs at the time of enrollment (N=1053) were glatiramer acetate (33.7%), subcutaneous interferon (IFN) b-1a (24.7%), intramuscular IFNb-1a (25.4%) and IFNb-1b (16.1%); median duration of DMT was 3.73 years. At baseline, the mean (SD) score for TSQM global satisfaction was 59.5 (22.7) and the effectiveness, side effects and convenience subscale scores were 61.9 (21.4), 69.2 (27.8) and 54.8 (21.2), respectively. The most common reasons for therapy change were dissatisfaction with the mode of administration (61.1%), tolerability (13.7%) and lack of efficacy (12.5%). Mean (SD) scores for PRIMUS-Activities, FSS and BDI-II were 5.2 (5.7), 4.7 (1.6) and 11.5 (9.1), respectively. Physical and mental component mean (SD) SF-36 scores were 41.7 (10.9) and 46.4 (12.0), respectively.

Conclusions CONCLUSIONS: Standard-of-care DMT satisfaction scores ranged from 55 to 69; convenience scores were lowest. Unsatisfactory mode of administration was the most common reason investigators and patients sought therapy change.

Authors/Disclosures
Mark C. Cascione, MD (Tampa Neurology Associates) PRESENTER	No disclosure on file
Walter R. Royal III, MD	No disclosure on file
Daniel R. Wynn, MD (Consultants in Neurology, Ltd.)	Dr. Wynn has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mylan. Dr. Wynn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Wynn has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Wynn has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Wynn has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TEVA. The institution of Dr. Wynn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Banner Life. Dr. Wynn has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Biogen. The institution of Dr. Wynn has received research support from Novartis. The institution of Dr. Wynn has received research support from Sanofi. The institution of Dr. Wynn has received research support from Adamas Pharmaceutics. The institution of Dr. Wynn has received research support from EMD Serono. The institution of Dr. Wynn has received research support from Roche. Dr. Wynn has a non-compensated relationship as a Director, Consultants in Neurology Comprehensive Care Center with National MS Society that is relevant to AAN interests or activities.
Neetu Agashivala (Novartis Pharmaceutical Corporation)	No disclosure on file
	No disclosure on file
	No disclosure on file
Lesley Schofield	No disclosure on file
Edward Kim (Novartis Pharmaceuticals Corporation)	No disclosure on file
Luigi M. Barbato, MD (Jazz Pharmaceuticals)	Dr. Barbato has nothing to disclose.

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