Department of Neurology, University Clinic Essen, University of Duisburg-Essen, Germany.
Eur J Neurol. 2010 Jan;17(1):31-7. doi: 10.1111/j.1468-1331.2009.02728.x. Epub 2009 Jul 9.
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.
Retrospective, multicenter study in Germany and Switzerland. Five major MS centers reported all RRMS patients who initiated natalizumab >or=12 months prior to study conduction.
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 >or= 1 EDSS point). Eighty-six per cent of patients with highly active disease (>or= 2 relapses in the year and >or= 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).
Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity.
那他珠单抗被推荐用于治疗对干扰素-β/醋酸格拉替雷(DMT)反应不足或活动性多发性硬化症(MS)的复发缓解型多发性硬化症(RRMS)患者。关键性试验并未针对该患者人群进行那他珠单抗单药治疗的研究。
德国和瑞士的回顾性多中心研究。5 家主要的 MS 中心报告了在研究开展前>或=12 个月开始接受那他珠单抗治疗的所有 RRMS 患者。
共纳入 97 例 RRMS 患者[69%为女性,平均年龄 36.5 岁,平均扩展残疾状况量表(EDSS)为 3.4;93.8%的患者在接受那他珠单抗治疗前接受了 DMT],那他珠单抗的平均治疗持续时间为 19.3 +/- 6.1 个月。我们发现年复发率从 2.3 降至 0.2,80.4%的患者在接受那他珠单抗治疗时无复发。EDSS 改善了 12.4%,89.7%的患者无进展(EDSS 变化>或= 1 分)。86%的高活动疾病患者(在研究入组时有>或= 2 次复发和>或= 1 次钆增强(Gd)病变,n = 20)仍无复发。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%(抗体阳性患者为 4.1%)。
那他珠单抗在对其他 DMT 反应不足或疾病活动度高的患者中也具有疗效。