BACKGROUND/OBJECTIVE Observational clinical data from cladribine-treated patients with relapsing forms of multiple sclerosis (MS) were recorded in the Australian MS registry powered by the MSBase registry platform (5-year follow-up) and analysed to complement information from the pivotal cladribine clinical trials in MS. METHODS A cohort of 90 cladribine-treated patients with follow-up data reported by treating physicians and recorded in the Australian MSBase registry (database lock February 2016) were examined. Clinical data included Expanded Disability Status Scale (EDSS) scores, relapses and other disease-modifying drugs (DMDs) administered before and after cladribine treatment. RESULTS Mean age on starting cladribine was 47 years; mean age at MS onset was 34 years, and median baseline EDSS score was 5.25. Disability trajectories in patients with sufficient follow-up suggested an overall increasing trend prior to cladribine treatment which was reduced during the 2-year post-treatment. Approximately 80% of patients were EDSS progression-free, 65% remained relapse-free after 2 years and median time to next DMD was 1.7 years. CONCLUSION These observational data suggest a disease-modifying effect in this cohort of relapsing MS patients characterised by older and more disabled patients. Since these data represent a single-arm cohort, clinical trials and larger comparative post-marketing studies are needed to validate and extend these findings.

中文翻译：

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克拉屈滨对澳大利亚多发性硬化症患者的真实疗效：MSBase 注册子研究


背景/目的 接受克拉屈滨治疗的复发型多发性硬化症 (MS) 患者的观察性临床数据记录在由 MSBase 注册平台支持的澳大利亚 MS 注册中心（5 年随访），并进行分析以补充来自关键克拉屈滨的信息MS 的临床试验。方法 对 90 名接受克拉屈滨治疗的患者进行队列检查，随访数据由治疗医生报告并记录在澳大利亚 MSBase 登记处（数据库锁定于 2016 年 2 月）。临床数据包括扩展残疾状态量表（EDSS）评分、复发和克拉屈滨治疗前后服用的其他疾病缓解药物（DMD）。结果 开始服用克拉屈滨的平均年龄为 47 岁； MS 发病的平均年龄为 34 岁，基线 EDSS 评分中位数为 5.25。经过充分随访的患者的残疾轨迹表明，在克拉屈滨治疗前总体呈增加趋势，而在治疗后 2 年期间有所减少。大约 80% 的患者 EDSS 无进展，65% 的患者在 2 年后仍无复发，距下一次 DMD 的中位时间为 1.7 年。结论 这些观察数据表明，对于以年龄较大和残疾程度较高的患者为特征的复发性多发性硬化症患者队列，具有疾病缓解作用。由于这些数据代表单臂队列，因此需要临床试验和更大规模的上市后比较研究来验证和扩展这些发现。