Patient-Reported Outcomes After Fingolimod Switch: Results By Prior Therapy

Background: Fingolimod is a once-daily, oral therapy approved for relapsing forms of multiple sclerosis (MS). Clinical trials have not assessed certain patient-reported outcomes after switch to fingolimod.

Objectives: Evaluate patient-reported outcomes after switch to fingolimod vs standard disease-modifying therapy (DMT) stratified by prior DMT.

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 interferon β [IFNβ] or glatiramer acetate [GA] therapy 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 the Treatment Satisfaction Questionnaire for Medication (TSQM) global satisfaction subscale (score range 0–100). Secondary outcomes were TSQM effectiveness, convenience, and side effects subscales; activities of daily living (Patient-Reported Indices for MS [PRIMUS]-Activities, range 0-30); Fatigue Severity Scale (FSS, range 1-7); Beck Depression Inventory-II (BDI-II, range 0-63); quality of life (Short Form Health Survey v2 standard [SF-36], range 0-100); and physician-assessed Clinical Global Impression of Improvement (CGI-I, range 1–7). This post hoc analysis used scores at 6 months (last observation carried forward [LOCF]) to assess outcomes stratified by prior DMT. Increases from BL in TSQM and SF-36, decreases from BL in PRIMUS, FSS, and BDI-II, and lower CGI-I scores indicate improvement.

Results: 1053 patients were randomized; prior DMT was IFNβ for 697 and GA for 355. For the TSQM global satisfaction subscale, mean ± SD change from BL to month 6 (LOCF) with fingolimod vs DMT was 21.7±27.3 vs 4.2±20.5 for patients switching from IFNβ and 17.3±32.5 vs 1.5±20.8 for patients switching from GA. Results for the other TSQM subscales by prior treatment were similar. Change from BL in PRIMUS-Activities scores with fingolimod vs DMT were −0.7±4.1 vs −0.1±4.3 for IFNβ and −0.2±5.2 vs −0.4±6.0 for GA. For the SF-36 summary measures, changes from BL with fingolimod vs DMT were 2.0±7.1 vs 0.2±6.5 for physical and 2.2±9.9 vs 0.2±9.3 for mental health for IFNβ; changes from BL were 1.2±8.0 vs 0.5±6.5 for physical and 2.4±10.3 vs 0.1±10.2 for mental health for GA. Change from BL in FSS total score with fingolimod vs DMT was −0.4±1.2 vs 0.0±0.9 for IFNβ and −0.2±1.3 vs 0.0±1.5 for GA. Change from BL in BDI-II total score with fingolimod vs DMT was −3.3±7.2 vs −0.7±6.0 for IFNβ and −3.3±8.2 vs −0.3±7.9 for GA. Mean ± SD CGI-I scores with fingolimod vs DMT were 3.2±1.1 vs 3.9±0.6 for patients switching from IFNβ and 3.2±1.2 vs 3.8±0.7 for patients switching from GA).

Conclusions: Patient-reported outcomes and physician-assessed CGI-I show consistent benefit of switching to fingolimod irrespective of prior DMT.