Demographic and clinic characteristics of French patients treated with natalizumab in clinical practice
Demographic and clinic characteristics of French patients treated with natalizumab in clinical practice
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DOI：
10.1007/s00415-009-5294-0
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发表时间：
2010-02-01
影响因子：
6
通讯作者：
de Seze, J.
中科院分区：
文献类型：
--
作者：
Outteryck, Olivier;Ongagna, J. -C.;de Seze, J.
那他珠单抗是第一个用于治疗活动性复发缓解型多发性硬化症（RRMS）的选择性粘附分子抑制剂。那他珠单抗自 2007 年 4 月起在法国上市。本研究的目的是分析在实际临床实践中接受那他珠单抗治疗的法国 RRMS 患者的人口统计、临床和耐受性数据，并与关键 AFFIRM 研究中的患者进行比较。自 2007 年 4 月以来任何时间在法国北部加来海峡和阿尔萨斯地区接受那他珠单抗治疗的所有 RRMS 患者均被纳入。分析的变量包括之前的治疗；残疾状况[扩展残疾状况量表（EDSS）评分]；基线时和治疗 12 个月后的年化复发率 (ARR)；和不良事件。评估了 384 名患者（72% 女性）的数据。平均基线 EDSS 评分为 3.53，平均基线 ARR 为 2.19，均显着高于 AFFIRM。 127 名患者完成了 12 个月的治疗；该组的平均 EDSS 评分为 3.02（降低 14%），平均 ARR 为 0.59（降低 73%）。尽管与 AFFIRM 中接受那他珠单抗的患者相比，这些患者的基线特征显着不同且残疾程度更大，但平均残疾程度保持稳定，ARR 下降了 73%。耐受性与 AFFIRM 中观察到的相似。
Natalizumab is the first selective adhesion molecule inhibitor indicated for treatment of active relapsing-remitting multiple sclerosis (RRMS). Natalizumab has been available in France since April 2007. The aims of this study are to analyze demographic, clinical, and tolerance data from French patients with RRMS treated with natalizumab in actual clinical practice and to draw comparisons with patients in the pivotal AFFIRM study. All patients with RRMS in the Nord-Pas de Calais and Alsace regions of France treated with natalizumab at any time since April 2007 were included. Variables analyzed included previous treatments; disability status [Expanded Disability Status Scale (EDSS) score]; annualized relapse rate (ARR) at baseline and after 12 months of treatment; and adverse events. Data from 384 patients (72% female) were evaluated. Mean baseline EDSS score was 3.53 and mean baseline ARR was 2.19, both significantly greater than in AFFIRM. One hundred twenty-seven patients completed 12 months of treatment; mean EDSS score in this group was 3.02 (14% reduction) and mean ARR was 0.59 (73% reduction). Although these patients had significantly different baseline characteristics and greater disability compared with patients receiving natalizumab in AFFIRM, average disability remained stable and ARR declined by 73%. Tolerability was similar to that observed in AFFIRM.