Abstract: Treatment Satisfaction and Clinical Improvement After Switch to Fingolimod (The 27th Annual Meeting of the CMSC and the 5th Cooperative Meeting of the CMSC-ACTRIMS)

Thursday, May 30, 2013

Edward Fox, MD, PhD , MS Clinic of Central Texas, Round Rock, TX

Keith Edwards, MD, FAAN , MS Center of NE New York, Latham, NY

J. Gordon Burch, MD, FRCP(C), FAAN , Blue Ridge Research Center, Roanoke, VA

Edward Kim, MD, MBA , Novartis Pharmaceuticals Corporation, East Hanover, NJ

Linda Pestreich, BSc , Novartis Pharmaceuticals Corporation, East Hanover, NJ

Kevin McCague, MA , Novartis Pharmaceuticals Corporation, East Hanover, NJ

Luigi M Barbato, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ

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Background: Fingolimod efficacy and safety have been established, but treatment satisfaction had not been assessed.

Objectives: To present patient-reported treatment satisfaction and physician-reported clinical improvement after change from disease-modifying therapy (DMT) to fingolimod.

Methods: Eligible patients for the phase 4, multicenter, 6-month study to Evaluate Patient OutComes (EPOC; NCT01216072) had relapsing MS, were fingolimod naive, and had received ≥6 months’ continuous treatment with a standard DMT (interferon β or glatiramer acetate). Patients were randomized 3:1 to open-label fingolimod 0.5 mg or standard DMT. The primary endpoint was change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) global satisfaction subscale score. Change from baseline in TSQM effectiveness, side effects, and convenience subscales, and the physician-reported Clinical Global Impression–Improvement (CGI-I) were secondary endpoints. TSQM scores were transformed to a 100-point scale; higher scores indicate greater satisfaction. The CGI-I is scored from 1-7, with 1=very much improved and 7=very much worse. Adverse events (AEs) were monitored.

Results: 943 (89.6%) patients completed the study. Patient characteristics were balanced across treatment groups. Baseline TSQM global satisfaction scores were 60.0 and 58.2 with fingolimod and DMT, respectively. By month 6, least squares [LS] mean scores increased by 20.4 with fingolimod vs 2.9 with DMT (LS mean treatment difference, 17.5; 95% CI, 14.22, 20.83; P<0.001; last observation carried forward). For TSQM effectiveness, side effects, and convenience subscales, LS mean treatment differences at month 6 were 12.5 (95% CI, 9.19, 15.72; P<0.001), 18.5 (95% CI, 15.31, 21.67; P<0.001), and 37.6 (95% CI, 35.64, 39.55; P<0.001), respectively. At month 6, mean (SD) CGI-I in the fingolimod vs DMT group was 3.2 (1.13) vs 3.9 (0.63; P<0.0001). AEs occurred in 78.8% vs 62.0% of patients with fingolimod and DMT, respectively; serious AEs occurred in 4.0% vs 2.0%. AEs most common with fingolimod were headache (12.4%), fatigue (11.5%), and upper respiratory tract infection (6.5%).

Conclusions: Patients reported greater treatment satisfaction, particularly regarding convenience, after therapy change to fingolimod vs continued treatment with a standard DMT; this corresponded with greater physician-perceived clinical improvement. AE patterns were similar to phase 3 trials and were expected given the study design.

DX29 Treatment Satisfaction and Clinical Improvement After Switch to Fingolimod