Truven Health Analytics, Cambridge, MA.
Clin Ther. 2013 Oct;35(10):1501-12. doi: 10.1016/j.clinthera.2013.07.330.
Patients with multiple sclerosis (MS) whose disease activity is inadequately controlled with a platform therapy (interferon beta or glatiramer acetate [GA]) may switch to another platform therapy or escalate therapy to natalizumab or fingolimod, which were approved in the US in 2006 and 2010, respectively.
The objective of this study was to describe treatment patterns in patients with multiple sclerosis (MS) in the United States who were followed for 2 years after initiating a disease-modifying therapy (DMT).
A retrospective observational cohort study was conducted to examine treatment patterns of initial DMT use (on initial therapy for 2 years with and without gaps of ≥ 60 days, medication switching, and discontinuation) among patients with MS who initiated a platform therapy (interferon-β or glatiramer acetate) or natalizumab between January 1, 2007, and September 30, 2009; the first DMT claim was the index. Eligible patients were identified in the MarketScan Commercial and Medicare Supplemental databases based on continuous enrollment for 6 months before (preindex period) and 24 months after their index date, with a diagnosis of MS and no claim for a previous DMT in the 6-month preindex period. Demographics at index and clinical characteristics during the preindex period were also analyzed.
A total of 6181 MS patients were included, with 5735 (92.8%) starting on platform therapy. Natalizumab initiators were more likely to stay on index therapy (32.3% vs 16.9%, P < 0.001) and have fewer treatment gaps of ≥ 60 days (44.8% vs 55.3%, P < 0.001) compared with platform initiators. In addition, natalizumab initiators were less likely to switch treatment (13.9% vs 19.1%, P = 0.007) and took longer to switch (400.9 days vs 330.7 days, P < 0.001) compared with platform initiators. Nearly 79% of platform initiators who switched went to another platform therapy. Approximately two thirds of patients who switched to a third DMT (n = 130) switched to another platform therapy. A total of 9% of natalizumab and platform initiators discontinued DMT within the 2 years.
Most MS patients initiating DMT started on platform therapy. Natalizumab initiators tended to stay on index therapy, have fewer treatment gaps, and switch less than platform initiators in the 2 years after treatment initiation. Switching between platform therapies is common despite evidence that MS patients on platform therapy may benefit from switching to natalizumab.
对于疾病活动控制不佳的多发性硬化症(MS)患者,在使用平台疗法(干扰素β或聚乙二醇干扰素)后,可能会更换为另一种平台疗法或升级为那他珠单抗或芬戈莫德治疗,后两者分别于 2006 年和 2010 年在美国获批。
本研究旨在描述美国多发性硬化症(MS)患者在启动疾病修正疗法(DMT)后 2 年内的治疗模式。
这是一项回顾性观察队列研究,对 2007 年 1 月 1 日至 2009 年 9 月 30 日期间接受平台疗法(干扰素β或聚乙二醇干扰素)或那他珠单抗治疗的 MS 患者进行初始 DMT 使用的治疗模式(2 年内无或有≥60 天的治疗中断、药物转换和停药)的描述性分析。首次 DMT 用药为起始点。在 MarketScan 商业和医疗保险补充数据库中,根据索引日期前 6 个月(预索引期)和索引日期后 24 个月的连续入组情况,确定符合条件的患者,并在预索引期的 6 个月内无 DMT 用药记录。还分析了索引时的人口统计学数据和预索引期的临床特征。
共纳入 6181 例 MS 患者,其中 5735 例(92.8%)开始使用平台疗法。那他珠单抗的起始患者更有可能持续使用指数疗法(32.3%比 16.9%,P<0.001)和较少出现≥60 天的治疗中断(44.8%比 55.3%,P<0.001)。此外,与平台起始患者相比,那他珠单抗起始患者较少发生药物转换(13.9%比 19.1%,P=0.007),药物转换时间更长(400.9 天比 330.7 天,P<0.001)。近 79%的平台起始患者在转换治疗时选择了另一种平台疗法。约三分之二转换为第三种 DMT(n=130)的患者转换为另一种平台疗法。那他珠单抗和平台起始患者中,分别有 9%和 9%在 2 年内停止了 DMT 治疗。
大多数开始 DMT 的 MS 患者开始使用平台疗法。与平台起始患者相比,那他珠单抗起始患者在治疗起始后 2 年内更倾向于持续使用指数疗法、较少出现治疗中断、药物转换率较低。尽管有证据表明平台疗法治疗的 MS 患者可能从转换为那他珠单抗中获益,但平台疗法之间的转换仍然很常见。