University of Alabama at Birmingham, Ryals Public Health Building 410B, 1665 University Boulevard, Birmingham, AL 35294-0022, USA; Pythagoras, Inc., Birmingham, AL 35205, USA.
Teva Pharmaceutical Industries Ltd, 41 Moores Rd, Malvern, PA 19355, USA.
Mult Scler Relat Disord. 2020 May;40:101957. doi: 10.1016/j.msard.2020.101957. Epub 2020 Jan 20.
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.
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.
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.
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.
复发缓解型多发性硬化症（RRMS）患者对治疗的满意度会直接影响其对治疗的依从性，进而影响治疗结果和成本。患者报告的结局（PROs）是评估多发性硬化症和其他疾病患者满意度的常用方法。
为期 12 个月、开放性、IV 期 CONFIDENCE 研究使用 PROs 评估 RRMS 患者的满意度和治疗依从性，以及接受醋酸格拉替雷治疗的 RRMS 患者的安全性结局。在该研究之前报道的（Cutter 等人，2019 年）初始 6 个月核心阶段，患者被随机分为每周 3 次（TIW）接受 40mg/ml 醋酸格拉替雷（GA40；n=431）或每日 1 次接受 20mg/ml 醋酸格拉替雷（GA20；n=430）。在 6 个月的单臂扩展阶段，完成核心阶段的 789 名患者接受 GA40 治疗，以确定核心阶段观察到的益处是否在扩展阶段持续，确定从 GA20 转换为 GA40 是否会导致 PRO 变化，并评估安全性结局。
在核心阶段，GA40 组患者对治疗的满意度、对治疗便利性的感知以及症状变化（疲劳影响和心理健康）的 PRO 评分均优于 GA20 组，在扩展阶段仍保持良好。在核心阶段，GA40 组的治疗依从性显著优于 GA20 组，在扩展阶段继续接受 GA40 治疗的患者中得以维持，而从 GA20 转换为 GA40 的患者在扩展阶段提高了依从性。整个研究期间安全性变量保持一致，从 GA20 转换为 GA40 的患者未观察到明显变化。
CONFIDENCE 研究扩展阶段的数据表明，GA40 治疗在药物满意度、治疗便利性感知、疲劳影响和心理健康症状变化以及治疗依从性方面的益处可在 12 个月的观察期内维持。这些结果证实了 GA40 相对于 GA20 在临床实践中的优势，从 GA20 转换为 GA40 没有额外的安全性问题。
