Long-term effectiveness in patients previously treated with cladribine tablets: a real-world analysis of the Italian multiple sclerosis registry (CLARINET-MS)
Long-term effectiveness in patients previously treated with cladribine tablets: a real-world analysis of the Italian multiple sclerosis registry (CLARINET-MS)
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DOI：
10.1177/1756286420922685
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发表时间：
2020-06-01
影响因子：
5.9
通讯作者：
Trojano, Maria
中科院分区：
文献类型：
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作者：
Patti, Francesco;Visconti, Andrea;Trojano, Maria
背景资料：MAGINET-MS研究评估了克拉屈滨片的长期有效性以下多发性硬化症（MS）患者在意大利，使用意大利MS Registry.Methods的数据：真实世界的数据（RWD）从意大利MS患者谁参加克拉屈滨片随机临床试验（RCT，MAGINITY扩展，ONWARD或ORACLE-MS）在17个MS中心从意大利MS注册。在设定的观察期内收集RWD，从RCT期间克拉屈滨片剂末次给药（定义为基线）至登记研究中的末次访视日期、治疗转换为其他疾病调节药物、末次扩展残疾状态量表记录日期或末次复发日期（以最后发生者为准）。使用Kaplan-Meier（KM）方法完成至事件发生时间分析。中位持续时间和相关的95%置信区间（CI）估计从model.Results：在意大利MS注册观察的时间跨度为1-137（中位数80.3）个月。在总意大利患者人群（n = 80）中，克拉屈滨片剂末次给药后12、36和60个月无复发概率的KM估计值分别为84.8%、66.2%和57.2%。末次给药后60个月无进展的相应概率为63.7%。KM估计的概率不启动另一种疾病修饰治疗后60个月的最后一剂克拉屈滨片为28.1%，中位时间到治疗的变化为32.1（95%CI 15.5-39.5）months.Conclusion：CRAINET-MS提供了一种间接措施的长期有效性克拉屈滨片。超过一半的MS患者在末次给药后60个月的随访期间没有复发或出现残疾进展，这表明克拉屈滨片剂在第1年和第2年开始的短期疗程后在第3年和第4年仍然有效。
Background: The CLARINET-MS study assessed the long-term effectiveness of cladribine tablets by following patients with multiple sclerosis (MS) in Italy, using data from the Italian MS Registry.Methods: Real-world data (RWD) from Italian MS patients who participated in cladribine tablets randomised clinical trials (RCTs; CLARITY, CLARITY Extension, ONWARD or ORACLE-MS) across 17 MS centres were obtained from the Italian MS Registry. RWD were collected during a set observation period, spanning from the last dose of cladribine tablets during the RCT (defined as baseline) to the last visit date in the registry, treatment switch to other disease-modifying drugs, date of last Expanded Disability Status Scale recording or date of the last relapse (whichever occurred last). Time-to-event analysis was completed using the Kaplan-Meier (KM) method. Median duration and associated 95% confidence intervals (CI) were estimated from the model.Results: Time span under observation in the Italian MS Registry was 1-137 (median 80.3) months. In the total Italian patient population (n = 80), the KM estimates for the probability of being relapse-free at 12, 36 and 60 months after the last dose of cladribine tablets were 84.8%, 66.2% and 57.2%, respectively. The corresponding probability of being progression-free at 60 months after the last dose was 63.7%. The KM estimate for the probability of not initiating another disease-modifying treatment at 60 months after the last dose of cladribine tablets was 28.1%, and the median time-to-treatment change was 32.1 (95% CI 15.5-39.5) months.Conclusion: CLARINET-MS provides an indirect measure of the long-term effectiveness of cladribine tablets. Over half of MS patients analysed did not relapse or experience disability progression during 60 months of follow-up from the last dose, suggesting that cladribine tablets remain effective in years 3 and 4 after short courses at the beginning of years 1 and 2.