复发型多发性硬化症患者的长期随访：CLASSIC-MS 中 CLARITY/CLARITY 扩展队列的前瞻性研究。

Long-term follow-up of patients with relapsing multiple sclerosis from the CLARITY/CLARITY Extension cohort of CLASSIC-MS: An ambispective study.

机构信息

Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

Department of Neurology, Neurosurgery and Medical Genetics, Federal Center of Brain Research and Neurotechnologies, Pirogov Russian National Research Medical University, Moscow, Russia.

出版信息

Mult Scler. 2023 May;29(6):719-730. doi: 10.1177/13524585231161494. Epub 2023 Apr 3.

BACKGROUND

CLASSIC-MS evaluated the long-term efficacy of cladribine tablets in patients with relapsing multiple sclerosis.

OBJECTIVE

Report long-term mobility and disability beyond treatment courses received in CLARITY/CLARITY Extension.

METHODS

This analysis represents CLASSIC-MS patients who participated in CLARITY with/without participation in CLARITY Extension, and received ⩾1 course of cladribine tablets or placebo ( = 435). Primary objective includes evaluation of long-term mobility (no wheelchair use in the 3 months prior to first visit in CLASSIC-MS and not bedridden at any time since last parent study dose (LPSD), i.e. Expanded Disability Status Scale (EDSS) score <7). Secondary objective includes long-term disability status (no use of an ambulatory device (EDSS < 6) at any time since LPSD).

RESULTS

At CLASSIC-MS baseline, mean ± standard deviation EDSS score was 3.9 ± 2.1 and the median time since LPSD was 10.9 (range = 9.3-14.9) years. Cladribine tablets-exposed population: 90.6% ( = 394), including 160 patients who received a cumulative dose of 3.5 mg/kg over 2 years. Patients not using a wheelchair and not bedridden: exposed, 90.0%; unexposed, 77.8%. Patients with no use of an ambulatory device: exposed, 81.2%; unexposed, 75.6%.

CONCLUSION

With a median 10.9 years' follow-up after CLARITY/CLARITY Extension, findings suggest the sustained long-term mobility and disability benefits of cladribine tablets.

背景

CLADRIBINE TABLETS IN MS （CLASSIC-MS）研究评估了克拉屈滨片在复发型多发性硬化症患者中的长期疗效。

目的

报告 CLARITY/CLARITY 扩展研究中接受疗程治疗之外的长期移动能力和残疾状况。

方法

本分析代表参与 CLARITY 且/或参与 CLARITY 扩展研究的 CLASSIC-MS 患者，并接受了 ⩾1 个疗程的克拉屈滨片或安慰剂（ = 435）。主要终点包括长期移动能力（在 CLASSIC-MS 首次就诊前 3 个月内未使用轮椅，且自上次父母研究剂量（LPSD）后未卧床不起，即扩展残疾状况量表（EDSS）评分 <7）的评估。次要终点包括长期残疾状况（自 LPSD 后任何时间均未使用助行器（EDSS <6）的评估。

结果

在 CLASSIC-MS 基线时，平均 ± 标准偏差 EDSS 评分 3.9 ± 2.1，自 LPSD 时间中位数为 10.9（范围 9.3-14.9）年。克拉屈滨片暴露人群：90.6%（ = 394），包括 160 名接受了 2 年累积剂量 3.5mg/kg 的患者。未使用轮椅且未卧床不起的患者：暴露组 90.0%；未暴露组 77.8%。未使用助行器的患者：暴露组 81.2%；未暴露组 75.6%。