Patient- and Physician-Reported Outcomes after Therapy Switch from Interferons or Glatiramer Acetate to Fingolimod

Background: Patients with relapsing MS who had received continual disease-modifying therapy (DMT) for ≥6 months (mo) were enrolled in the phase 4, open-label, 6-mo Evaluate Patient Outcomes, Tolerability, and Safety of Fingolimod (EPOC) study and randomized 3:1 to fingolimod 0.5 mg once daily or standard-of-care DMT.

Objectives: To assess patient- and physician-reported outcomes in patients receiving interferon (IFN) who stayed on IFN, patients receiving glatiramer acetate (GA) who stayed on GA, and patients receiving each agent who switched to fingolimod.

Methods: Post-hoc analyses determined least squares mean (LSM) changes from baseline (BL) to 6 mo (last observation carried forward) in Treatment Satisfaction Questionnaire for Medication (TSQM; 0–100 scale, higher scores=greater satisfaction), Beck Depression Inventory-II (BDI-II), Fatigue Severity Scale (FSS), and physician-assessed Clinical Global Impression of Improvement (CGI-I) scores.

Results: 205 patients switched to fingolimod from intramuscular (IM) IFN beta–1a (IFNa), 196 from subcutaneous (SC) IFNa, and 125 from SC IFN beta-1b (IFNb), while 48, 58, and 39 patients stayed on IM IFNa, SC IFNa, and IFNb, respectively; 262 switched from GA to fingolimod, and 74 stayed on GA. LSM change from BL to 6 mo in TSQM Global Satisfaction scores favored switching to fingolimod vs remaining on IFN (17.57 vs 2.10 [IM IFNa], 24.7 vs 2.29 [SC IFNa] and 22.34 vs 4.45 [IFNb; all P<0.001] or GA [17.08 vs 0.81]; P<0.001). LSM changes from BL to 6 mo in TSQM subscale scores for fingolimod vs IFN were: Effectiveness, 13.31 vs 1.37 (IM IFNa), 15.07 vs 1.62 (SC IFNa), 17.59 vs 0.68 (IFNb); Side Effects, 30.62 vs 6.56 (IM IFNa), 27.83 vs –0.42 (SC IFNa), 21.50 vs –1.24 (IFNb); Convenience, 43.83 vs 5.70 (IM IFNa), 42.36 vs 1.66 (SC IFNa), 41.57 vs 1.31 (IFNb; all P<0.001). LSM changes from BL favored fingolimod vs GA for Effectiveness (12.16 vs 0.62; P<0.001) and Convenience (38.01 vs 3.11; P<0.001). A nonsignificant trend existed for the Side Effects subscale (9.25 vs 4.47; P=0.111). Changes in FSS and BDI-II favored switching to fingolimod vs remaining on IFN or GA, although not all differences were statistically significant. Changes in CGI-I favored switching to fingolimod vs remaining on IFN or GA (all P<0.001).

Conclusions: Switching to fingolimod was associated with improved patient-reported treatment satisfaction and physician assessments relative to not switching from IFN or GA.