Center for Clinical Neuroscience, Department of Neurology, University Hospital Carl Gustav Carus Dresden, Technical University of Dresden, Fetscherstraße 74, 01307 Dresden, Germany.
Merck Healthcare Germany GmbH, an affiliate of Merck KGaA; Waldstr. 3, 64331 Weiterstadt, Germany.
Mult Scler Relat Disord. 2024 Oct;90:105812. doi: 10.1016/j.msard.2024.105812. Epub 2024 Aug 10.
Cladribine tablets for the treatment of relapsing multiple sclerosis (RMS) are administered in two pulsed treatment courses in two consecutive years, totalling a maximum of 20 treatment days. Here we present data collected shortly after the launch of cladribine tablets, focusing on the patient's perspective. The objective was to investigate patients' perceived effectiveness, tolerability, and convenience, as well as global satisfaction of and with cladribine tablets.
CLEVER was a non-interventional multicentre study conducted in Germany from 12/2017 to 7/2020. Adult patients with RMS initiating therapy with cladribine tablets were included. Observation time per patient was 24 weeks, comprising 3 visits (baseline, week 4 and 24). The primary endpoint was overall treatment satisfaction at week 24, assessed by the Treatment Satisfaction Questionnaire for Medication 14 items (TSQM 1.4). Subgroup analyses included stratification by prior treatment.
In total, 491 patients (69.2 % female; mean (±SD) age 40.3 (±11.5) years, 85.1 % pre-treated, median EDSS 2.5) initiated therapy with cladribine tablets and were included in the analysis. At week 24, the mean (±SD) global TSQM satisfaction score was 75.6 (±19.0). For patients switching from either injectables or oral medication, the change in therapy satisfaction from baseline to week 24 was positive in all TSQM domains with clinically meaningful effect sizes in the global satisfaction and side effects domains. Most patients (85.5 %) remained relapse-free over 24 weeks. Out of 491 patients, 187 (38.1 %) experienced at least one adverse event and 8 patients (1.6 %) one serious adverse event.
Treatment satisfaction with cladribine tablets was high. The switch from prior injectables or oral medication translated into increased treatment satisfaction at week 24 with clinically meaningful effects in the global satisfaction and side effects domains. Effectiveness and safety were consistent with results from clinical studies.
用于治疗复发型多发性硬化症（RMS）的克拉屈滨片剂在连续两年的两个脉冲治疗疗程中给药，总共最多 20 个治疗日。 在这里，我们提供了在克拉屈滨片剂推出后不久收集的数据，重点关注患者的观点。 目的是调查患者对有效性、耐受性和便利性的感知，以及对克拉屈滨片剂的总体满意度。
CLEVER 是一项在德国进行的非干预性多中心研究，从 2017 年 12 月至 2020 年 7 月进行。纳入初始接受克拉屈滨片剂治疗的 RMS 成年患者。每位患者的观察时间为 24 周，包括 3 次就诊（基线、第 4 周和第 24 周）。主要终点是第 24 周的总体治疗满意度，通过治疗药物满意度问卷 14 项（TSQM 1.4）进行评估。亚组分析包括按既往治疗进行分层。
共有 491 名患者（69.2%为女性；平均（±SD）年龄 40.3（±11.5）岁，85.1%为预处理，中位 EDSS 2.5）接受克拉屈滨片剂治疗并纳入分析。在第 24 周，平均（±SD）全球 TSQM 满意度评分为 75.6（±19.0）。对于从注射剂或口服药物转为克拉屈滨片剂的患者，从基线到第 24 周的治疗满意度变化在所有 TSQM 领域均为阳性，在全球满意度和副作用领域具有有临床意义的效应大小。在 24 周内，大多数患者（85.5%）无复发。在 491 名患者中，有 187 名（38.1%）发生至少 1 次不良事件，8 名（1.6%）发生 1 次严重不良事件。
克拉屈滨片剂的治疗满意度很高。从既往的注射剂或口服药物转为克拉屈滨片剂，在第 24 周时治疗满意度增加，在全球满意度和副作用领域具有有临床意义的效应。有效性和安全性与临床研究结果一致。
