Nervenfachärztliche Gemeinschaftspraxis Ulm, Ulm, Germany.
Merck Healthcare Germany GmbH (an Affiliate of Merck KGaA, Darmstadt, Germany), Waldstraße 3, 64331, Weiterstadt, Germany.
Adv Ther. 2023 Dec;40(12):5547-5556. doi: 10.1007/s12325-023-02682-z. Epub 2023 Sep 30.
Patient-reported outcomes (PROs) provide an insightful method of assessing the subjective impact of therapies for those affected by multiple sclerosis (MS), a chronic neurologic disease notable for symptoms of fatigue and reduced physical function. The ongoing CLAWIR study aims to assess the effect of cladribine tablets (3.5 mg/kg cumulative dose over 2 years) in patients with highly active relapsing MS focusing on PROs of fatigue, physical function, treatment satisfaction, and work productivity. Here, we report on a pre-planned analysis at 12 months after treatment initiation with cladribine tablets.
CLAWIR is a 2-year, multicenter, prospective, observational study of patients with relapsing MS newly initiating cladribine tablets. The following PROs were analyzed: PRO Measurement Information System (PROMIS) Fatigue MS (v1.0) and Physical Function MS (v2.1), Treatment Satisfaction Questionnaire for Medication (TSQM, v1.4), and Work Productivity and Activity Impairment MS Questionnaire (WPAI-MS). Data were analyzed descriptively.
In total, 128 patients were eligible for analysis: 95 females (74.2%); median (range) age 34.5 (29, 44) years; 34 patients (26.6%) were treatment-naïve, and 89 (69.5%) were early switchers from platform therapies (the remaining 5 patients [3.9%] switched from a high-efficacy disease-modifying therapy). PROMIS Fatigue MS mean (± standard deviation [SD]) T-scores decreased from 54.6 (± 9.59) at baseline to 51.8 (± 10.30) at 12 months, indicating an alleviation of fatigue, whereas PROMIS Physical Function MS mean T-scores remained stable over time [baseline: 49.4 (± 10.69); 12 months: 50.3 (± 10.88)]. TSQM v1.4 mean scores indicated an improvement over time, increasing from 52.2 (± 27.79) at baseline to 81.4 (± 17.06) at 12 months for global satisfaction. WPAI-MS scores also showed an improvement across all four domains over 12 months.
This real-world study demonstrates the effect of cladribine tablets over 12 months on PROs of fatigue, physical function, treatment satisfaction, and work productivity.
The CLAWIR study is registered at the German Federal Institute for Drugs and Medical Devices with the internal NIS number 7469.
患者报告的结果（PROs）为评估多发性硬化症（MS）患者治疗的主观影响提供了一种有见地的方法，这是一种慢性神经系统疾病，以疲劳和身体功能下降为特征。正在进行的 CLAWIR 研究旨在评估氯法拉滨片（2 年内累积剂量 3.5mg/kg）在高度活跃的复发型 MS 患者中的疗效，重点关注疲劳、身体功能、治疗满意度和工作生产力的 PROs。在此，我们报告了氯法拉滨片治疗开始后 12 个月的预先计划分析。
CLAWIR 是一项为期 2 年、多中心、前瞻性、观察性研究，纳入了新开始氯法拉滨片治疗的复发型 MS 患者。分析了以下 PROs：PRO 测量信息系统（PROMIS）疲劳 MS（v1.0）和身体功能 MS（v2.1）、治疗满意度问卷药物版（TSQM，v1.4）和工作生产力和活动障碍 MS 问卷（WPAI-MS）。数据采用描述性分析。
共有 128 名患者符合分析条件：95 名女性（74.2%）；中位（范围）年龄 34.5（29，44）岁；34 名患者（26.6%）为初治患者，89 名（69.5%）为平台治疗的早期转换者（其余 5 名患者[3.9%]从高效疾病修正治疗药物转换）。PROMIS 疲劳 MS 平均（±标准差[SD]）T 评分从基线时的 54.6（±9.59）降至 12 个月时的 51.8（±10.30），表明疲劳减轻，而 PROMIS 身体功能 MS 平均 T 评分随时间保持稳定[基线：49.4（±10.69）；12 个月：50.3（±10.88）]。TSQM v1.4 的平均评分随着时间的推移而增加，全球满意度从基线时的 52.2（±27.79）增加到 12 个月时的 81.4（±17.06）。WPAI-MS 评分在 12 个月内也在所有四个领域均有所改善。
这项真实世界的研究表明，氯法拉滨片在 12 个月内对疲劳、身体功能、治疗满意度和工作生产力的 PROs 有影响。
CLAWIR 研究在德国联邦药物和医疗器械研究所注册，内部登记号为 7469。
