Impact of natalizumab on ambulatory improvement in secondary progressive and disabled relapsing-remitting multiple sclerosis.
Impact of natalizumab on ambulatory improvement in secondary progressive and disabled relapsing-remitting multiple sclerosis.
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DOI：
10.1371/journal.pone.0053297
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
Lee S
中科院分区：
文献类型：
--
作者：
Cadavid D;Jurgensen S;Lee S
对于改善多发性硬化症残疾患者的运动功能的疾病修饰疗法的需求尚未得到满足。评估natalizumab对复发-缓解型多发性硬化症（RRMS）或继发性进行性多发性硬化症（SPMS）残疾患者动态功能的影响。我们回顾性回顾了扩展残疾状态量表评分≥3.5分的临床试验受试者的行走功能，包括来自3期AFFIRM和SENTINEL试验的RRMS受试者，来自2期MS231研究的复发性SPMS受试者，以及来自1b期DELIVER研究的非复发性SPMS受试者。为了比较，肌肉注射干扰素β-1a (IM IFNβ-1a) IMPACT研究的SPMS受试者也进行了分析。使用T25FW应答器状态测量走动的改善；反应被定义为在较短（6 - 9个月）或较长（24 - 30个月）的治疗期间，相对于受试者的最佳服药前步行时间，更快的步行时间。在纳塔珠单抗组的残疾MS受试者中，T25FW应答者是安慰剂组或IM IFNβ-1a组的2 - 4倍。有反应的人比没有反应的人平均快24%-45%。Natalizumab可改善残疾RRMS患者的运动功能，并可能对残疾SPMS患者有效。在一项前瞻性SPMS研究中证实后者的发现是有必要的。
There is an unmet need for disease-modifying therapies to improve ambulatory function in disabled subjects with multiple sclerosis. Assess the effects of natalizumab on ambulatory function in disabled subjects with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS). We retrospectively reviewed ambulatory function as measured by timed 25-foot walk (T25FW) in clinical trial subjects with an Expanded Disability Status Scale score ≥3.5, including RRMS subjects from the phase 3 AFFIRM and SENTINEL trials, relapsing SPMS subjects from the phase 2 MS231 study, and nonrelapsing SPMS subjects from the phase 1b DELIVER study. For comparison, SPMS subjects from the intramuscular interferon beta-1a (IM IFNβ-1a) IMPACT study were also analyzed. Improvement in ambulation was measured using T25FW responder status; response was defined as faster walking times over shorter (6–9-month) or longer (24–30-month) treatment periods relative to subjects’ best predose walking times. There were two to four times more T25FW responders among disabled MS subjects in the natalizumab arms than in the placebo or IM IFNβ-1a arms. Responders walked 25 feet an average of 24%–45% faster than nonresponders. Natalizumab improves ambulatory function in disabled RRMS subjects and may have efficacy in disabled SPMS subjects. Confirmation of the latter finding in a prospective SPMS study is warranted.
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影响因子：
5.8
作者：
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通讯作者：
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DOI：
10.2165/11591150-000000000-00000
发表时间：
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