Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS.

BACKGROUND:Patients who perceive their medication to be ineffective or inconvenient are less likely to be adherent to treatment, with potentially significant consequences on long-term clinical outcomes. Many patients with multiple sclerosis (MS) are nonadherent to treatment despite demonstrated efficacy of disease-modifying therapies (DMTs). While glatiramer acetate (GA; Copaxone®, Teva Pharmaceuticals) both 20 mg/mL once daily (GA20) and 40 mg/mL three times weekly (GA40) have demonstrated efficacy in relapsing-remitting MS (RRMS), GA40 has a superior tolerability profile in addition to a more convenient dosing schedule. These characteristics may give rise to greater treatment satisfaction and higher rates of adherence with potentially beneficial effects on clinical outcomes and health-related costs. METHODS:CONFIDENCE was a Phase 4, interventional, open-label, randomized, 2-arm, parallel-group, global study with a duration of 6 months. Patients (N = 861) were randomly assigned 1:1 to receive GA20 (n = 430) or GA40 (n = 431) during the core phase. The primary endpoint was patient-reported medication satisfaction using the Medication Satisfaction Questionnaire (MSQ). Secondary endpoints included self-reported convenience perception using the Treatment Satisfaction Questionnaire for Medication-9 convenience component, symptomatic changes (Modified Fatigue Impact Scale, MFIS), and Mental Health Inventory (MHI). Treatment adherence was measured by Multiple Sclerosis Treatment Adherence Questionnaire. Results from the core phase were included. RESULTS:During the core phase, 857 patients received treatments. Patients on GA40 were statistically significantly more satisfied with their medication than those on GA20 (LSM difference in MSQ, 0.3; 95% CI, 0.2, 0.5; p<0.001). Additionally, patients on GA40 found the treatment more convenient (p<0.001), were more adherent (p = 0.002), and reported statistically significant greater improvements in the MFIS Cognitive (p = 0.043) and the MHI Behavior Control (p = 0.014) subscales versus those on GA20. There were no new safety findings. CONCLUSIONS:Higher levels of satisfaction, perception of convenience, and adherence were reported by patients on GA40 than those on GA20. CLINICAL TRIAL REGISTRATION NUMBER:This trial was registered with ClinicalTrials.gov (NCT02499900).