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

Abstract

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

Use of pragmatic randomized trials in multiple sclerosis: A systematic overview

“…Our search retrieved 420 records with 53 eligible publications reporting on 48 trials 22–69 (Appendices 1 and 2).…”

“…Most trials assessed non-pharmacological interventions ( n = 41; 85%) with primarily lifestyle ( n = 18; 38%) and/or behavioral ( n = 13; 27%) components (Figure 1 and Table 3). Only seven trials assessed drugs (15%; alemtuzumab, 34 corticotrophin, 65,69 glatiramer acetate, 28 natalizumab, 60 interferon beta-1a, 67 and fingolimod); 64 these were published between 1967 and 2019 (median 2014) and had a median of 350 participants (IQR = 70–745; overall 3601). The most frequent comparator was usual care ( n = 25; 52%).…”

“…76 In MS, the trials that we identified were rather small compared to the examples from cardiology outlined above. Among the largest ones was the CONFIDENCE study 28 with almost 1000 participants from 88 study centers in 14 countries that answered the question which of two doses of glatiramer acetate provided more medication satisfaction (in this study, pwMS preferred glatiramer acetate 40 mg three times weekly to 20 mg once daily). The CONFIDENCE study still had features that were not perfectly in line with a pragmatic intend (e.g.…”

Long-term efficacy and safety of three times weekly dosing regimen of glatiramer acetate in relapsing multiple sclerosis patients: Seven-year results of the Glatiramer Acetate Low-frequency Administration (GALA) open-label extension study

“…The overall retention rate (60%) is supported by recent research demonstrating high patient satisfaction and adherence with GA40. 6,7 Another limitation is the lack of MRI data from three to seven years. The three-year results showed that ES and DS patients exhibited similar numbers of GdE T1 and new or enlarging T2 lesions 4 ; however, ES patients exhibited significantly smaller changes in gray matter volume than DS patients from Year 1 to Year 3 (mean difference, 0.371%; p = 0.02), with a similar trend in whole-brain volume ( p = 0.08).…”

“…5 A recent open-label study demonstrated significantly greater patient satisfaction, better treatment adherence, reduced impact of fatigue on patient activities, and improved patient-reported mental health for patients treated with GA40 versus GA20. 6 These significant differences were maintained over a 12-month period. 7 However, long-term data on the efficacy and safety of GA40 are lacking.…”