Efficacy of natalizumab in second line therapy of relapsing-remitting multiple sclerosis: results from a multi-center study in German speaking countries
Efficacy of natalizumab in second line therapy of relapsing-remitting multiple sclerosis: results from a multi-center study in German speaking countries
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DOI：
10.1111/j.1468-1331.2009.02728.x
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发表时间：
2010-01-01
影响因子：
5.1
通讯作者：
Limmroth, V.
中科院分区：
文献类型：
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作者：
Putzki, N.;Yaldizli, O.;Limmroth, V.
背景：那他珠单抗已被推荐用于治疗复发缓解型多发性硬化症（RRMS）的患者干扰素-β/醋酸格拉替雷（DMT）或积极的MS反应不足。关键性试验没有进行调查那他珠单抗单药治疗在这个patient population.Method：回顾性，多中心研究在德国和瑞士。五个主要的MS中心报告了所有在研究进行前开始natalizumab治疗≥ 12个月的RRMS患者。结果：纳入了97例RRMS患者[69%为女性，平均年龄36.5岁，平均扩展残疾状态量表（EDSS）3.4; 93.8%接受了DMT预治疗]，平均治疗持续时间为19.3 +/- 6.1个月。我们发现，使用那他珠单抗后，年复发率从2.3降至0.2，80.4%的患者无复发。12.4%的患者EDSS改善，89.7%的患者无进展（EDSS变化>/= 1分）。86%的高活动性疾病患者（年内复发>/= 2次，研究入组时>/= 1个钆（Gd）+病变，n = 20）保持无复发。Gd增强病变的平均数量减少至0.1（基线时为0.8）。停药率为8.2%（抗体阳性为4.1%）。结论：那他珠单抗在对其他DMT反应不足以及疾病活动度高的患者中有效。
Background:Natalizumab has been recommended for the treatment of relapsing-remitting multiple sclerosis (RRMS) in patients with insufficient response to interferon-beta/glatiramer acetate (DMT) or aggressive MS. The pivotal trials were not conducted to investigate natalizumab monotherapy in this patient population.Method:Retrospective, multicenter study in Germany and Switzerland. Five major MS centers reported all RRMS patients who initiated natalizumab >= 12 months prior to study conduction.Results:Ninety-seven RRMS patients were included [69% female, mean age 36.5 years, mean Expanded Disability Status Scale (EDSS) 3.4; 93.8% were pre-treated with DMT], mean treatment duration with natalizumab was 19.3 +/- 6.1 months. We found a reduction of the annualized relapse rate from 2.3 to 0.2, 80.4% were relapse free with natalizumab. EDSS improved in 12.4% and 89.7% were progression free (change of >/= 1 EDSS point). Eighty-six per cent of patients with highly active disease (>/= 2 relapses in the year and >/= 1 Gadolinium (Gd)+ lesion at study entry, n = 20) remained relapse free. The mean number of Gd enhancing lesions was reduced to 0.1 (0.8 at baseline). Discontinuation rate was 8.2% (4.1% for antibody-positivity).Conclusion:Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity.