Satisfaction and adherence with glatiramer acetate 40mg/mL TIW in RRMS after 12 months, and the effect of switching from 20mg/mL QD

Abstract

Background: Patient satisfaction with treatment in relapsing-remitting multiple sclerosis (RRMS) has a direct impact on adherence to treatment and, consequently, upon treatment outcomes and costs. Patient-reported outcomes (PROs) are a common method for determining patient satisfaction in MS and other diseases.

Methods: The 12-month, open-label, Phase IV CONFIDENCE study assessed patient satisfaction and treatment adherence, using PROs, as well as safety outcomes in patients with RRMS treated with glatiramer acetate (GA). In the previously reported (Cutter et al., 2019) initial 6-month core phase of the study, patients were randomized to receive three-times-weekly (TIW) GA 40 mg/mL (GA40; n = 431) or once-daily GA 20 mg/mL (GA20; n = 430). In the 6-month, single-arm extension phase, 789 patients completing the core phase were treated with GA40 to determine whether benefits observed in the core phase were sustained during the extension phase, to ascertain if switching from GA20 to GA40 resulted in PRO changes, and to assess safety outcomes.

Results: Superior PRO scores for patient satisfaction with treatment, patient perception of treatment convenience, and symptomatic changes (fatigue impact and mental health) observed in the GA40 group versus the GA20 group in the core phase were all maintained in the extension phase. Treatment adherence, significantly greater in the GA40 versus the GA20 group in the core phase, was sustained in patients continuing to receive GA40 in the extension phase, while those who switched from GA20 to GA40 increased their adherence during the extension phase. Safety variables remained consistent throughout the study, with no notable changes observed in patients switching from GA20 to GA40.

Conclusions: Data from the extension phase of the CONFIDENCE study show that the benefits associated with GA40 treatment in terms of medication satisfaction, treatment convenience perception, symptomatic changes in fatigue impact and mental health status, and treatment adherence were maintained over a 12-month observation period. These results confirm the preferential utility of GA40 versus GA20 in clinical practice, with no additional safety concerns associated with switching from GA20 to GA40.

Keywords: Adherence; Copaxone; Glatiramer acetate; Multiple sclerosis; Patient satisfaction; RRMS.