Department of Neurosciences, Level 4 Central Wing, University Hospitals of Coventry and Warwickshire, Clifford Bridge Road, Coventry, CV2 2DX, UK; Warwick Evidence, Warwick Medical School, Gibbet Hill Campus, Coventry, CV4 7AL, UK.
Department of Neurosciences, Level 4 Central Wing, University Hospitals of Coventry and Warwickshire, Clifford Bridge Road, Coventry, CV2 2DX, UK.
Mult Scler Relat Disord. 2024 Oct;90:105837. doi: 10.1016/j.msard.2024.105837. Epub 2024 Aug 23.
Cladribine is an oral disease-modifying drug approved for the treatment of highly active relapsing multiple sclerosis (MS). The recommended number of treatment courses is two, with the courses given 1 year apart (i.e., in year 1 and year 2), followed by 2 years without treatment. Pivotal clinical trials showed that, compared with placebo, cladribine significantly reduced relapse rates, risk of disability progression and magnetic resonance imaging measures of disease activity for up to 4 years in treatment-naïve or -experienced adults with relapsing-remitting MS (RRMS). The management of patients and requirement for retreatment with cladribine beyond year 4 is unclear.
We describe the treatment history and outcomes of three people with MS retreated with cladribine, given as a third course 5 years after treatment initiation. We also include a review of evidence on retreatment with cladribine from year 3 onwards and a discussion of patient selection criteria for retreatment.
The cases included a 53-year-old female patient with RRMS, a 43-year-old female patient with RRMS, and a 42-year-old male patient with RRMS. Six months after the third course of cladribine, all three patients were relapse-free and stable on magnetic resonance imaging, with no evidence of disease activity. At 11-12 months follow-up, all patients had clinical and radiological stability (i.e., no evidence of disease activity).
Continuation of oral cladribine treatment may be considered for people with MS beyond year 5 following completion of the initial two courses. Our real-world experience is ongoing and additional data are required to obtain insight into patient phenotypes which predict response to cladribine treatment.
克拉屈滨是一种口服疾病修正药物，已获准用于治疗高度活跃的复发型多发性硬化症（MS）。推荐的治疗疗程为两个，疗程间隔为 1 年（即第 1 年和第 2 年），随后 2 年不治疗。关键性临床试验表明，与安慰剂相比，克拉屈滨可显著降低复发率、残疾进展风险和磁共振成像（MRI）疾病活动指标，在未经治疗或治疗过的复发缓解型多发性硬化症（RRMS）成人中，治疗效果可持续长达 4 年。在 4 年之后，患者的管理和再次使用克拉屈滨治疗的需求尚不清楚。
我们描述了 3 名 MS 患者在起始治疗 5 年后再次接受克拉屈滨治疗的治疗史和结局。我们还回顾了从第 3 年开始再次使用克拉屈滨的证据，并讨论了再次治疗的患者选择标准。
这 3 个病例包括 1 名 53 岁女性 RRMS 患者、1 名 43 岁女性 RRMS 患者和 1 名 42 岁男性 RRMS 患者。在接受第 3 个疗程的克拉屈滨后 6 个月，所有 3 名患者均无复发，MRI 稳定，无疾病活动迹象。在 11-12 个月的随访中，所有患者的临床和放射学均稳定（即无疾病活动迹象）。
在初始两疗程完成后 5 年以上，可考虑继续对 MS 患者使用口服克拉屈滨治疗。我们的真实世界经验仍在继续，需要更多的数据来深入了解预测克拉屈滨治疗反应的患者表型。
