Improved quality of life after therapy change to fingolimod

Objectives: Few data are available pertaining to the impact of fingolimod on quality of life (QoL). Our objective is to present patientreported change in QoL, activities of daily living (ADL), fatigue, and depression after therapy switch from standard‐of‐care disease‐modifying therapy (DMT) for relapsing multiple sclerosis (MS) to fingolimod 0.5 mg. Methods: Eligible patients for the phase 4, multicentre, 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 beta or glatiramer acetate) before study initiation. Patients were randomised 3:1 to open‐label fingolimod 0.5 mg or standard DMT. Changes from baseline in PROs reported herein were secondary endpoints. The following PRO instruments were used: health‐related QoL, Short Form Health Survey v2 standard (SF‐36 v2), range of possible scores, 0‐100; ADL, Patient‐Reported Indices for MS scale (PRIMUS‐Activities), range 0‐30; fatigue, Fatigue Severity Scale (FSS), range 1‐7; depression, Beck Depression Inventory‐II (BDI‐II), range 0‐63. Higher scores on the PRIMUSActivities, BDI‐II, and FSS represent worse functioning/symptoms; lower scores on SF‐36 represent worse QoL. Treatment differences were analysed by analysis of covariance, last observation carried forward. Results: Improvement in mean scores for all PROs was observed from baseline to end of study in the fingolimod group. Statistically significant differences between fingolimod (n = 789) vs DMT (n = 263) in change from baseline score were observed for the SF‐36 v2 physical component summary (1.7 vs 0.4 for fingolimod vs DMT, respectively; least squares [LS] mean treatment difference, ‐1.3 [95 % CI, ‐2.31, ‐0.30]; P = 0.011), the SF‐36 v2 mental component summary (2.2 vs 0.4; LS mean difference, ‐1.7 [‐3.07, ‐0.41]; P = 0.011), FSS (‐0.3 vs 0.0; LS mean difference, 0.3 [0.18, 0.51]; P<0.001), and BDI‐II (‐3.2 vs ‐0.8; LS mean difference, 2.5 [1.50, 3.44]; P<0.001). The treatment difference observed on PRIMUSActivities (‐0.6 vs ‐0.2; LS mean difference, 0.4 [‐0.26, 0.96]) was not statistically significant (P = 0.258). Conclusion: Therapy change to fingolimod 0.5 mg was associated with greater improvements in physical and mental QoL, fatigue symptoms, and depression symptoms vs continued treatment with standard DMT.