CG15 Relationship Between Treatment Satisfaction and Other Patient-Reported Outcomes

Thursday, May 30, 2013
Daniel Kantor, MD , Neurologique, Ponte Vedra, FL
Neetu Agashivala, MS , Health Economics & Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ
Stanley Li, MS , Minimax Information Services, Belle Mead, NJ
Ron Hashmonay, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Peter Chin, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Edward Kim, MD, MBA , Health Economics & Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ

Background: Fingolimod is a once-daily, oral therapy approved for relapsing forms of multiple sclerosis (MS). Clinical trials have demonstrated fingolimod’s efficacy and safety, but there are no data on patient satisfaction after switching to fingolimod.

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.