新品牌非专利药特立氟胺治疗复发缓解型多发性硬化症的患者报告结果

IF 1.8 4区 医学 Q3 CLINICAL NEUROLOGY
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引用次数: 0

摘要

背景患者报告结果(PROs)为了解疾病改变疗法(DMTs)对患者日常生活和疾病进展的影响提供了宝贵的信息。本研究评估了使用 Zistdaru Danesh Biopharmaceuticals 公司生产的品牌非专利药特利氟胺(Tebazio®,14 毫克片剂)的患者的治疗满意度和耐受性。材料与方法对开始使用或转用 14 毫克特利氟胺的复发性多发性硬化症(RRMS)患者进行了一项 IV 期观察性研究。研究的主要重点是药物的安全性。患者满意度采用药物治疗满意度问卷[1.4版](TSQM-14)进行测量。此外,还对服药依从性和停药率进行了监测。结果 在235名RRMS患者中,所有患者都参与了这项研究,每天口服特立氟胺治疗。在18个月的随访期间,25.96%的患者中断了治疗。中止治疗的主要原因是不良反应(11%)、患者不愿意继续治疗(12.7%)和疾病进展(4.2%)。最常报告的不良反应包括皮肤病、肝酶升高和胃肠道问题。TSQM-14评分在18个月期间有显著改善。结论患者对特立氟胺的满意度很高,这反映在他们的 TSQM 分数上,这表明患者的依从性有可能得到改善。伊朗 RRMS 患者对 14 毫克品牌非专利药物特立氟胺的接受度很高,在研究过程中没有出现重大问题。这些研究结果还凸显了患者报告的结果在 DMTs 中的重要性,对患者的依从性和临床实践具有潜在的益处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The patient-reported outcomes for the new brand-generic teriflunomide in relapsing-remitting multiple sclerosis

Background

Patient-reported outcomes (PROs) provide valuable insights into the impact of disease-modifying therapies (DMTs) on patients' daily lives and disease progression. This study evaluates treatment satisfaction and tolerability among patients using a brand-generic Teriflunomide (Tebazio®, 14 mg tablet) manufactured by Zistdaru Danesh Biopharmaceuticals.

Materials and Methods

A Phase IV observational study was conducted on patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who were either initiated on or switched to Teriflunomide 14 mg. The primary focus was on the medication's safety. Patient satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication [Version 1.4] (TSQM-14). Additionally, medication adherence and discontinuation rates were monitored.

Results

Of the 235 RRMS patients enrolled, participated in this study, all received the Teriflunomide treatment orally on a daily basis. Over the 18-month follow-up period, 25.96 % of patients discontinued the treatment. Discontinuation was mainly due to adverse events (11 %), lack of patient willingness to continue (12.7 %), and disease progression (4.2 %). The most commonly reported adverse events included dermatologic disorders, elevated liver enzymes, and gastrointestinal issues. TSQM-14 scores demonstrated significant improvements over the 18-month period. A high medication adherence rate of 98.1 % was also recorded.

Conclusion

Patients reported notable satisfaction with Teriflunomide, as reflected in their TSQM scores, which suggests a likelihood of improved patient adherence. The 14 mg brand-generic Teriflunomide was well-accepted by Iranian RRMS patients, with no significant concerns arising during the study. These findings also highlight the significance of patient-reported outcomes in DMTs, with potential benefits for adherence and clinical practice.

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来源期刊
Clinical Neurology and Neurosurgery
Clinical Neurology and Neurosurgery 医学-临床神经学
CiteScore
3.70
自引率
5.30%
发文量
358
审稿时长
46 days
期刊介绍: Clinical Neurology and Neurosurgery is devoted to publishing papers and reports on the clinical aspects of neurology and neurosurgery. It is an international forum for papers of high scientific standard that are of interest to Neurologists and Neurosurgeons world-wide.
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