多发性硬化症患者皮下注射 IFNβ-1a 的依从性：使用 RebiSmart 的剂量记录和读数功能进行的非干预性研究 READOUTsmart 的最终分析。
Adherence to Subcutaneous IFN β-1a in Multiple Sclerosis: Final Analysis of the Non-Interventional Study READOUTsmart Using the Dosing Log and Readout Function of RebiSmart.
机构信息
Hospital for Nervous Diseases, Medical Park Loipl, Bischofswiesen, Germany.
Hans Berger Department of Neurology, University Hospital Jena, Jena, Germany.
出版信息
Adv Ther. 2019 Jan;36(1):175-186. doi: 10.1007/s12325-018-0839-1. Epub 2018 Nov 28.
INTRODUCTION
Patient adherence is a key determinant of treatment success in multiple sclerosis (MS). The RebiSmart autoinjector facilitates patient self-injection of subcutaneous interferon β-1a (sc IFN β-1a) and allows quantitative measurement of adherence via its automated dosing log. We evaluated patient adherence and patient-reported cognitive and health-economic outcomes over 2 years in patients using RebiSmart.
METHODS
In this non-interventional, single-arm study, enrolled patients were 12-65 years of age, had relapsing-remitting MS or a single demyelinating event, and had been prescribed 44 or 22 μg sc IFN β-1a. Quantitative adherence (proportion of scheduled injections administered) and qualitative adherence (proportion of weeks with treatment schedule correctly followed) were monitored over 2 years. Other end points included self-assessed adherence, patient-reported outcomes (fatigue, depression and quality of life), cognitive outcomes and health-economic outcomes.
RESULTS
A total of 368 of 392 (93.9%) enrolled patients were analyzed. Mean quantitative adherence was 85.3% overall (months 1-24), 89.6% for months 1-12 and 83.3% for months 13-24. No major impact on quantitative adherence was observed for sex, age (< 37 years vs. ≥ 37 years), prior medication or participation in the patient support program RebiSTAR. Mean qualitative adherence was 67.0% overall (months 1-24). Self-assessed adherence was reported as being higher than RebiSmart-monitored adherence. There was a trend toward more MS-related visits to physicians among patients with high adherence.
CONCLUSIONS
Patients using RebiSmart demonstrated high adherence to treatment that was associated with a slight improvement in information processing speed and working memory and an overall tendency for more intensive self-management.
FUNDING
Merck Serono GmbH, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.
简介
患者的遵医嘱程度是多发性硬化症（MS）治疗成功的关键决定因素。RebiSmart 自动注射器便于患者进行皮下注射干扰素β-1a（sc IFN β-1a），并通过其自动剂量记录来定量测量遵医嘱程度。我们评估了使用 RebiSmart 的患者在 2 年内的遵医嘱程度和患者报告的认知及健康经济学结局。
方法
在这项非干预性、单臂研究中，纳入的患者年龄为 12-65 岁，患有复发缓解型多发性硬化症或单一脱髓鞘事件，处方剂量为 44 或 22 μg sc IFN β-1a。在 2 年内监测定量遵医嘱程度（计划注射次数的比例）和定性遵医嘱程度（按治疗方案正确遵循的周数比例）。其他终点包括自我评估的遵医嘱程度、患者报告的结局（疲劳、抑郁和生活质量）、认知结局和健康经济学结局。
结果
共分析了 392 名入组患者中的 368 名（93.9%）。总体而言，定量遵医嘱程度的平均值为 85.3%（第 1-24 个月），第 1-12 个月为 89.6%，第 13-24 个月为 83.3%。性、年龄（<37 岁与≥37 岁）、既往用药或参与患者支持计划 RebiSTAR 对定量遵医嘱程度没有显著影响。总体而言，定性遵医嘱程度的平均值为 67.0%（第 1-24 个月）。患者自我报告的遵医嘱程度高于 RebiSmart 监测的遵医嘱程度。高遵医嘱程度的患者到医生处就诊的次数呈增加趋势。
结论
使用 RebiSmart 的患者对治疗的遵医嘱程度很高，这与信息处理速度和工作记忆的轻微改善以及更强化的自我管理倾向有关。
经费
德国默克雪兰诺有限公司，德国默克股份公司的子公司。
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