Objectives: To evaluate the relationship between patient satisfaction and other patient-reported outcomes after fingolimod switch in patients with relapsing MS.
Methods: The study to Evaluate Patient OutComes (EPOC) is a phase 4, open-label, multicenter, 6-month study in patients with relapsing MS naive to fingolimod who had received continuous treatment with interferon β [IFNβ] or glatiramer acetate [GA] for ≥6 months before study initiation. Patients were randomized 3:1 to once-daily fingolimod 0.5 mg or standard disease-modifying therapy (DMT; GA, IFNβ-1a intramuscularly [IM], IFNβ-1a subcutaneously [SC], and IFNβ-1b SC). The primary endpoint was change from baseline (BL) in the Treatment Satisfaction Questionnaire for Medication (TSQM) global satisfaction subscale (transformed to 100-point scale). Secondary patient-reported outcomes were TSQM effectiveness, convenience, and side effects subscales; activities of daily living (Patient-Reported Indices for MS [PRIMUS]-Activities); Fatigue Severity Scale (FSS); Beck Depression Inventory-II (BDI-II); and quality of life (Short Form Health Survey v2 standard [SF-36]). Higher TSQM and SF-36 scores and lower PRIMUS, FSS, and BDI-II scores indicate better outcome. This post hoc analysis assessed correlations between TSQM global satisfaction subscale and secondary outcomes using Spearman rank order correlation.
Results: 1053 patients were randomized; 942 (fingolimod, n=714; DMT, n=229) completed the study. Analysis of the primary endpoint is reported separately. In both groups, TSQM global satisfaction scores significantly correlated with all patient-reported outcomes at months 3 and 6 (each P<0.001). Correlations (month 6) were strongest for the TSQM effectiveness subscale (fingolimod, rho=0.68; DMT, rho=0.71) compared with the convenience (fingolimod, rho=0.31; DMT, rho=0.53) and side effects subscales (fingolimod, rho=0.33; DMT, rho=0.33). At 6 months, TSQM global satisfaction correlations (fingolimod vs DMT) with the other scales were as follows: BDI total scores, −0.33 vs −0.28; FSS total scores −0.24 vs −0.36, PRIMUS-Activities −0.28 vs −0.27 (LOCF), SF-36 physical health 0.29 vs 0.25 (LOCF), and SF-36 mental health 0.29 vs 0.31 (LOCF).
Conclusions: In patients switching to fingolimod or remaining on standard DMT, TSQM global satisfaction correlated consistently with all patient-reported outcomes, with strongest correlations for the TSQM effectiveness subscale. These results suggest that increased patient satisfaction reflects a variety of improvements, including therapy effectiveness.