Patient-Reported Outcomes After Fingolimod Switch: Early Consistent Benefit

Background: Fingolimod, a once-daily, oral therapy approved for relapsing forms of multiple sclerosis (MS), has demonstrated efficacy for clinical and magnetic resonance imaging outcomes. However, data on patient perspectives with fingolimod are lacking.

Objectives: Evaluate early patient-reported outcomes 3 months after switching to fingolimod vs standard disease-modifying therapy (DMT) in patients with relapsing MS.

Methods: The study to Evaluate Patient OutComes (EPOC) is a phase 4, open-label, multicenter, 6-month study in patients with relapsing MS. Eligible patients were fingolimod naive and had received continuous treatment with interferon β [IFNβ] or glatiramer acetate [GA] for ≥6 months before study initiation. Patients were randomized 3:1 to once-daily fingolimod 0.5 mg or standard DMT (GA, intramuscular [IM] IFNβ-1a, subcutaneous [SC] IFNβ-1a, and IFNβ-1b SC). The primary endpoint was change from baseline (BL) in treatment satisfaction assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM) global satisfaction subscale (score range 0–100). Change from BL in TSQM effectiveness, convenience, and side effects subscales; fatigue (Fatigue Severity Scale [FSS], range 1-7); and depression (Beck Depression Inventory-II [BDI-II], range 0-63); and physician-assessed Clinical Global Impression of Improvement (CGI-I, range 1–7) were secondary outcomes. This post hoc analysis reports outcomes measured at month 3; increases from BL in TSQM, decreases from BL in FSS and BDI-II, and lower CGI-I scores represent improvement.

Results: 1053 patients were randomized, and 942 (fingolimod, n=714 [90%]; DMT, n=229 [87%]) completed the study. For the TSQM global satisfaction subscale, mean ± SD improvement from BL with fingolimod vs DMT was 21.2±28.0 vs 3.6±19.4 at 3 months. For the other TSQM subscales, change from BL at 3 months with fingolimod vs DMT was 13.9±25.8 vs 3.2±19.3 for effectiveness, 21.5±31.3 vs 5.2±26.2 for side effects, and 40.4±23.5 vs 4.1±17.7 for convenience. Change from BL at 3 months with fingolimod vs DMT was −0.3±1.2 vs 0.0±1.1 for FSS total score and −3.2±7.2 vs −0.8±6.6 for BDI-II total score. Mean ± SD CGI-I scores with fingolimod vs DMT were 3.4±1.0 vs 3.9±0.7. These data were consistent with observations at 6 months (data reported separately). Results of subgroup analyses stratified by age, sex, time on prior treatment, time since first symptom, and Expanded Disability Status Scale will be presented.

Conclusions: These data suggest a benefit as early as 3 months after switching to fingolimod across a variety of patient-reported outcomes and physician impression of improvement.