Blizard Institute, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.
Casa di Cura Privata del Policlinico, Universita Vita-Salute San Raffaele, Milan, Italy.
Neurodegener Dis Manag. 2022 Dec;12(6):295-301. doi: 10.2217/nmt-2022-0018. Epub 2022 Aug 26.
WHAT IS THIS SUMMARY ABOUT?: This is a summary of an article originally published in the journal . Cladribine tablets are approved for treating people with relapsing multiple sclerosis (shortened to MS). People with MS take cladribine tablets for 2 periods of 4 to 5 days per year. This analysis looks at the results from 2 studies called the CLARITY and CLARITY Extension studies. These studies looked at what effect a 2-year course of treatment with cladribine tablets had on disability over 5 years in people with MS.
HOW WAS THE ANALYSIS CARRIED OUT?: In this analysis, researchers measured disability worsening at regular intervals during the 2-year treatment period in the CLARITY study and thereafter in the 2-year CLARITY Extension study. As many patients had a bridging interval between CLARITY and CLARITY extension, the researchers were able to assess disability over a 5-year timeframe.
WHAT WERE THE RESULTS?: When measurements were taken at Year 5 of the study, disability remained stable in more than half of participants. Over the 5-year period, 70% of participants did not experience persistent disease worsening that lasted more than 6 months.
WHAT DO THE RESULTS MEAN?: Researchers concluded that a 2-year course of cladribine tablets may provide long-term benefits on disability for up to 5 years. : NCT00213135 (ClinicalTrials.gov) : NCT00641537 (ClinicalTrials.gov).
这是一篇原发于期刊的文章的摘要。克拉屈滨片获批用于治疗复发性多发性硬化症（简称 MS）患者。MS 患者每年接受克拉屈滨片治疗 2 个疗程，每个疗程为期 4-5 天。这项分析研究着眼于 CLARITY 和 CLARITY 扩展两项研究的结果。这两项研究旨在评估为期 2 年的克拉屈滨片治疗对 MS 患者 5 年内残疾进展的影响。
这项分析中，研究者在 CLARITY 研究的 2 年治疗期间以及此后的 CLARITY 扩展研究的 2 年期间，每隔一段时间对残疾恶化进行测量。由于许多患者在 CLARITY 和 CLARITY 扩展之间存在桥接间隔，因此研究人员能够评估 5 年的时间框架内的残疾情况。
研究结果显示，在研究的第 5 年进行测量时，超过一半的参与者的残疾状况保持稳定。在 5 年期间内，70%的参与者未经历持续超过 6 个月的疾病恶化。
研究者得出结论，为期 2 年的克拉屈滨片治疗方案可能会带来长达 5 年的长期残疾获益。
NCT00213135（ClinicalTrials.gov）；NCT00641537（ClinicalTrials.gov）。
