DX20 Improved Quality of Life After Therapy Change to Fingolimod

Thursday, May 30, 2013
Heidi Crayton, MD , MS Center of Greater Washington, Vienna, VA
Samuel F. Hunter, MD, PhD , Advanced Neurosciences Institute, Franklin, TN
Cynthia Huffman, MD , Meridien Research, Tampa, FL
Neetu Agashivala, MS , Health Economics & Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ
Lesley Schofield, PhD , 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

Background: Few data are available pertaining to the impact of fingolimod on quality of life (QoL).

Objectives: To present patient-reported 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, 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) before study initiation. Patients were randomized 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 PRIMUS-Activities, BDI-II, and FSS represent worse functioning/symptoms; lower scores on SF-36 represent worse QoL. Treatment differences were analyzed 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 PRIMUS-Activities (–0.6 vs –0.2; LS mean difference, 0.4 [–0.26, 0.96]) was not statistically significant (P=0.258).

Conclusions: 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.