Patient- and physician-reported outcomes after therapy switch from glatiramer acetate to fingolimod versus staying on glatiramer acetate

Background: The phase 4 study to Evaluate Patient Outcomes, Tolerability, and Safety of Fingolimod (EPOC) enrolled patients with relapsing MS who had received continual treatment with a disease‐modifying therapy (DMT) for >6 months before study start. Patients were randomised 3:1 to once‐daily, open‐label fingolimod 0.5 mg or standard‐of‐care DMT. Objective: To evaluate patient‐ and physician‐reported outcomes in the subgroup of patients with an immediate history of glatiramer acetate (GA) treatment who either randomly switched to fingolimod or remained on GA Methods: This post‐hoc analysis evaluated the change from baseline (BL) to month 6 (last observation carried forward) for the following instruments: Treatment Satisfaction Questionnaire for Medication (TSQM; score range 0‐100; higher scores = greater satisfaction), Beck Depression Inventory‐II (BDI‐II; score range, 0‐63; higher scores = worse depression), Fatigue Severity Scale (FSS; score range 1‐7; higher scores = worse fatigue), and the physician‐assessed Clinical Global Impression of Improvement (CGI‐I; score range 1‐7 with 1 = very much improved and 7 = very much worse). Least squares means (LSM) were estimated by analysis of covariance adjusted for BL. Results: 262 patients switched from GA to fingolimod at randomisation and 74 patients remained on GA. BL characteristics and instrument scores were generally balanced across treatment groups. LSM change from BL in the TSQM Global Satisfaction score favored fingolimod (17.08 vs 0.81; P < 0.001). BL scores for fingolimod vs GA, respectively, were 61.1 vs 62.4 and month 6 scores were 78.2 vs 62.7. LSM changes from BL also favored fingolimod for TSQM Effectiveness (12.16 vs 0.62; P < 0.001) and Convenience subscales (38.01 vs 3.11; P < 0.001). A nonsignificant trend was observed for the Side Effects subscale (9.25 vs 4.47; P = 0.111). There was no difference on the FSS (LSM change, ‐0.18 for fingolimod vs 0.03 for GA, P = 0.218). Improvements in depressive symptoms favored switching to fingolimod (BDI‐II LSM change, ‐3.17 vs ‐1.03; P = 0.030) and physicians perceived greater clinical improvement with fingolimod vs GA (CGI‐I month 6 LSM score, 3.23 vs 3.78; P < 0.001). Conclusions: Compared with remaining on GA treatment, switching from GA to fingolimod was associated with greater improvement in treatment satisfaction, particularly effectiveness and convenience, after 6 months of treatment; this corresponded with greater improvement in depression and greater physicianperceived overall improvement.