Abteilung für Neurologie, Universitätsklinikum Münster , Münster, Germany.
Klinik für Neurologie und Klinische Neurophysiologie, Universitätsklinikum Augsburg , Germany.
Expert Opin Pharmacother. 2020 Nov;21(16):1965-1969. doi: 10.1080/14656566.2020.1792885. Epub 2020 Jul 13.
Oral cladribine is a highly effective pulsed selective immune reconstitution therapy licensed for relapsing multiple sclerosis. A full treatment course comprises two treatment cycles given with 1 year of intermission. Further dosing is not routinely recommended in years 3 and 4.
The long-term management of patients treated with oral cladribine has not been fully defined on the basis of clinical studies as of yet. The authors provide their expert opinion on this.
Based on available evidence and experience from routine clinical use, the authors suggest a structured approach to the long-term management of patients treated with cladribine tablets according to their responder type, i. e. the degree and timing of disease activity, if any, after treatment initiation. Informed treatment decisions require structured patient monitoring by established clinical and imaging parameters. In patients with relevant disease activity in year 3 or 4 and beyond, the use of additional cycle(s) of oral cladribine might become an option. For patients requiring a treatment switch, the choice of therapies primarily includes moderately to highly effective MS drugs.
口服克拉屈滨是一种高效的脉冲选择性免疫重建疗法,已获得批准用于治疗复发型多发性硬化症。一个完整的治疗周期包括两个治疗周期,其间间隔 1 年。在第 3 年和第 4 年通常不建议进一步给药。
迄今为止,基于临床研究,尚未完全确定接受口服克拉屈滨治疗的患者的长期管理。作者就这一点提供了专业意见。
根据现有证据和常规临床应用经验,作者建议根据应答类型(即治疗开始后疾病活动的程度和时间),对接受克拉屈滨片治疗的患者进行长期管理,采用一种结构化方法。有必要通过既定的临床和影像学参数对患者进行结构化监测,以便做出明智的治疗决策。对于在第 3 年或之后仍有相关疾病活动的患者,可能需要选择额外的口服克拉屈滨周期。对于需要治疗转换的患者,治疗选择主要包括中度至高度有效的多发性硬化症药物。