REBISTART：多发性硬化症患者在患者支持计划背景下坚持皮下注射β干扰素治疗。

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2024-06-01 Epub Date: 2024-03-26 DOI:10.1007/s40120-024-00593-x

Matthias Schwab, Andrew Chan, Anna-Katharina Eser, Boris Kallmann, Dieter Pöhlau, Joachim Richter, Torsten B Wagner, Christoph Grothe

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引用次数: 0

摘要

导言：坚持治疗是多发性硬化症（MS）疾病改变疗法（DMT）取得成功的关键因素。REBISTART研究前瞻性地评估了患者使用患者支持计划（PSP）组件的依从性：这项为期 12 个月的非干预性多中心研究考察了皮下注射干扰素 beta-1a (Rebif®) 的实际依从性。患者评估的依从性通过视觉模拟量表（VAS）和莫里斯基用药依从性量表（MMAS）进行测量。客观依从性数据通过 RebiSmart® 注射装置的读数获得：在 333 名患者中，70.9% 的患者使用护理服务作为 PSP 的核心组成部分。基于 VAS 的自我评估依从性长期稳定在 94.0%-96.3% 之间。同样，MMAS 评分（最高 4 分）在所有就诊中均为 3.8-3.9，这也反映出自我评估的依从性很高。在使用 RebiSmart® 注射装置的 269 名患者中，基于读数的客观依从性平均值同样很高（93.0-98.4%）。在最后一次就诊时，基于 VAS 的依从性与是否参与 PSP 护理服务无关（参与护理服务的依从性为 93.1%，未参与护理服务的依从性为 91.7%）。依从性也不受注射方法或疾病相关指标（包括疲劳、抑郁、认知和生活质量）的影响。提前终止治疗的最常见原因（38.7% 的患者）是 "改变治疗方法"（10.0%）：讨论：我们认为，可能特别受益于 PSP 的亚群体包括独居患者、使用多种药物的患者以及受认知障碍、抑郁和/或疲劳影响的患者。进一步的研究应探讨 PSP 在这些人群中的潜在作用：在一年的治疗过程中，独立于 PSP 护理服务的极高依从率表明，IFN β-1a sc 是一种易于使用且耐受性良好的疾病调节药物：试验注册号：Vfa.de：https://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb/nis-details/_892 .

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REBISTART: Adherence of Patients with Multiple Sclerosis to Treatment with Subcutaneous Interferon Beta in the Context of a Patient Support Program.

Introduction: Treatment adherence is a critical success factor in the disease-modifying therapy (DMT) of multiple sclerosis (MS). The REBISTART study prospectively evaluated adherence in patients using components of a patient support program (PSP).

Methods: The 12-month non-interventional multicenter study examined the real-world adherence to subcutaneously (sc) injected interferon beta-1a (Rebif^®). Patient-assessed adherence was measured by a visual analog scale (VAS) and the Morisky Medication Adherence Scale (MMAS). Objective adherence data were obtained by readouts from the RebiSmart^® injection device.

Results: Of 333 patients, 70.9% used the nursing service as the core component of the PSP. Self-assessed VAS-based adherence was stable over time at 94.0-96.3%. Similarly, MMAS score (maximum 4) was 3.8-3.9 at all visits, also reflecting high self-assessed adherence. In 269 patients using the RebiSmart^® injection device, mean readout-based objective adherence was similarly high (93.0-98.4% throughout visits). At last available visit, VAS-based adherence was independent of participation in the PSP nursing service (93.1% with participation versus 91.7% without it). Adherence was also independent of injection method or disease-related measures, including fatigue, depression, cognition, and quality of life. The most frequent reason for the premature discontinuations (38.7% of patients) was "change of treatment" (10.0%).

Discussion: We suggest that subgroups that may specifically benefit from PSP include patients who live alone, use multiple comedications, and are affected by cognitive impairment, depression, and/or fatigue. Further studies should investigate the potential usefulness of PSPs in these populations.

Conclusions: Very high adherence rates independent of the PSP nursing service over 1 year of treatment indicate that IFN beta-1a sc is an easy-to-use and well-tolerated disease-modifying drug.

Trial registration number: Vfa.de: No. 892. https://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb/nis-details/_892 .

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

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