Department of Neurological & Behavioural Sciences, University of Siena, Siena, Italy/Department of Medicine, Surgery & Neuroscience, University of Siena, Siena, Italy.
Department of Health Sciences, University of Genoa & Ospedale Policlinico San Martino IRCCS, Genoa, Italy.
Neurodegener Dis Manag. 2022 Dec;12(6):303-310. doi: 10.2217/nmt-2022-0019. Epub 2022 Aug 26.
WHAT IS THIS SUMMARY ABOUT?: This is a summary of an article originally published in the . The article presents the results from the CLARITY and CLARITY Extension studies, which looked at how well cladribine tablets work in treating people with multiple sclerosis (shortened to MS). Cladribine tablets are a medication approved for treating relapsing forms of MS. This study looked at how treatment with cladribine tablets affects the frequency and severity of relapses in people with MS. A relapse is when new symptoms develop or old symptoms return or get worse after a period of stability or improvement.
WHAT HAPPENED IN THE STUDIES?: In the CLARITY study, 870 people received either cladribine tablets (3.5 mg/kg, the approved dose) or placebo (a dummy pill). After the CLARITY study ended, some participants who received cladribine tablets chose to take part in a second study called the CLARITY Extension study. Of these participants, 98 were given placebo for 2 more years following an interval period of up to 10 months between participating in each study.
WHAT WERE THE RESULTS?: People with MS who were treated with cladribine tablets for 2 years in the CLARITY study had lower risks of any relapse compared with those given placebo. Participants taking placebo (after cladribine tablets) in the CLARITY Extension study experienced these same benefits, which continued for up to 3 more years after having received cladribine tablets in the CLARITY study.
WHAT DO THE RESULTS MEAN?: Researchers concluded the recommended 2-year dosing of cladribine tablets may reduce the number and severity of relapses in people with MS for up to 5 years. : NCT00213135 (ClinicalTrials.gov) : NCT00641537 (ClinicalTrials.gov).
这是一篇最初发表在《柳叶刀》杂志上的文章的摘要。该文章介绍了 cladribine 片剂治疗多发性硬化症（简称 MS）患者的疗效研究结果。 cladribine 片剂是一种已批准用于治疗复发性 MS 的药物。这项研究旨在观察 cladribine 片剂治疗对 MS 患者复发频率和严重程度的影响。复发是指在稳定或改善期后出现新症状或原有症状再次出现或恶化。
在 CLARITY 研究中，870 名参与者分别接受 cladribine 片剂（3.5mg/kg，批准剂量）或安慰剂（一种假药丸）治疗。在 CLARITY 研究结束后，一些接受 cladribine 片剂治疗的参与者选择参加第二项名为 CLARITY 扩展研究的研究。在这项研究中，98 名参与者在间隔长达 10 个月的时间后，在接受 cladribine 片剂治疗 2 年后的间隔期内接受了 2 年的安慰剂治疗。
与接受安慰剂治疗的参与者相比，接受 cladribine 片剂治疗 2 年的 MS 患者在 CLARITY 研究中出现任何复发的风险较低。在 CLARITY 扩展研究中接受安慰剂（在 cladribine 片剂之后）的参与者也经历了这些相同的益处，这些益处持续了 3 年多，之后他们在 CLARITY 研究中接受了 cladribine 片剂治疗。
研究人员得出结论， cladribine 片剂的推荐 2 年剂量可能会减少 MS 患者在 5 年内的复发次数和严重程度。
NCT00213135（ClinicalTrials.gov）；NCT00641537（ClinicalTrials.gov）。
