Hardy Todd A, Parratt John, Beadnall Heidi, Blum Stefan, Macdonell Richard, Beran Roy G, Shuey Neil, Lee Andrew, Carroll William, Shaw Cameron, Worrell Richard, Moody Jana, Sedhom Mamdouh, Barnett Michael, Vucic Steve
Department of Neurology, Concord Repatriation General Hospital, Concord, New South Wales, Australia.
Brain and Mind Centre, The University of Sydney, Sydney, New South Wales, Australia.
BMJ Neurol Open. 2022 Jul 4;4(2):e000315. doi: 10.1136/bmjno-2022-000315. eCollection 2022.
Adherence and persistence are critical to optimising therapeutic benefit from disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS). This prospective, open-label, multicentre, observational study (AubPRO), conducted in 13 hospital-based neurology clinics around Australia, describes treatment satisfaction in patients newly initiated on teriflunomide (Aubagio) and evaluates the use of an electronic patient-reported outcome (PRO) tool.
Patients (≥18 years) newly initiated on teriflunomide (14 mg/day) were followed up at 24 and 48 weeks. Patients completed questionnaires and pill counts electronically using MObile Data in Multiple Sclerosis. The primary endpoint was treatment satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM, V.1.4), at week 48. Secondary endpoints included treatment satisfaction at week 24, other PRO scales, clinical outcomes, medication adherence and safety.
Patients (n=103; 54 (52.4%) treatment naive) were mostly female (n=82 (79.6%)), aged 49.5 (11.8) years, with MS duration since symptom onset of 9.1 (11.8) years and a median Expanded Disability Status Scale score of 1.0. Mean treatment satisfaction scores were high (≥60%) across all domains of the TSQM V.1.4 at week 24 and at week 48. Compared with week 24, week 48 treatment satisfaction increased for patients who were treatment naïve and for those previously on another oral or injectable DMT. Over 48 weeks, PROs remained stable across a range of measures including disability, physical health, emotional health and mobility, and there were improvements in work capacity and daily life activity. Adherence was high throughout the study with mean compliance (pill counts) of 93.2%±6.26%, and 98 of 103 (95.1%) patients remained relapse-free.
This cohort of Australian patients with RRMS, newly initiated on teriflunomide, and treated in a real-world clinical practice setting, reported high treatment satisfaction and adherence at 24 and 48 weeks. Patient-reported measures of disability remained stably low, work capacity and daily life activity improved, and most patients remained relapse-free.
在复发缓解型多发性硬化症(RRMS)中,依从性和持续性对于优化疾病修正疗法(DMTs)的治疗效果至关重要。这项前瞻性、开放标签、多中心观察性研究(AubPRO)在澳大利亚各地13家医院的神经内科诊所开展,描述了新开始使用特立氟胺(奥巴捷)的患者的治疗满意度,并评估了一种电子患者报告结局(PRO)工具的使用情况。
新开始使用特立氟胺(14毫克/天)的患者(≥18岁)在24周和48周时接受随访。患者使用多发性硬化症移动数据以电子方式完成问卷调查和药片计数。主要终点是在第48周时通过药物治疗满意度问卷(TSQM,V.1.4)测量的治疗满意度。次要终点包括第24周时的治疗满意度、其他PRO量表、临床结局、药物依从性和安全性。
患者(n = 103;54例(52.4%)为初治患者)大多为女性(n = 82例(79.6%)),年龄49.5(11.8)岁,自症状发作以来的MS病程为9.1(11.8)年,扩展残疾状态量表评分中位数为1.0。在第24周和第48周时,TSQM V.1.4所有领域的平均治疗满意度得分均较高(≥60%)。与第24周相比,初治患者以及之前使用过另一种口服或注射用DMT的患者在第48周时的治疗满意度有所提高。在48周期间,一系列指标(包括残疾、身体健康、情绪健康和活动能力)的PROs保持稳定,工作能力和日常生活活动有所改善。在整个研究过程中,依从性较高,平均依从性(药片计数)为93.2%±6.26%,103例患者中有98例(95.1%)无复发。
这组新开始使用特立氟胺并在真实临床实践环境中接受治疗的澳大利亚RRMS患者在第24周和第48周时报告了较高的治疗满意度和依从性。患者报告的残疾指标持续稳定在较低水平,工作能力和日常生活活动有所改善,大多数患者无复发。