Multiple Sclerosis Centre, S. Andrea Hospital, La Sapienza University, Via di Grottarossa 1035, 00189, Rome, Italy.
Neurol Sci. 2011 Jan;31 Suppl 3:303-7. doi: 10.1007/s10072-010-0348-8.
We reported a post-marketing experience of 190 patients affected by relapsing multiple sclerosis on treatment with natalizumab. Clinical findings during pre-treatment period and throughout the study were documented. Magnetic resonance imaging (MRI) scans were performed at baseline and at 6, 12, and 24 months of therapy. Cumulative proportions of patients disease activity free (i.e. absence of relapses, disability progression, MRI activity) were measured as efficacy endpoints. Despite that the baseline characteristics suggested a more severe course of disease in our sample than that of the AFFIRM trial, data on effectiveness of natalizumab were comparable. At 1 year of treatment we found 80 and 70% patients free from relapses and MRI activity, respectively, that is similar to 75 and 62% detected in the AFFIRM trial. Moreover, only 5% of our patients showed a progression of disability after a mean follow-up time of 15 months. Finally, the presence of antibodies anti-Natalizumab was strongly related to the occurrence of relapses (p = 0.002) and MRI activity (p < 0.001) even in the post-marketing experience.
我们报告了 190 例接受那他珠单抗治疗的复发性多发性硬化症患者的上市后经验。记录了治疗前和整个研究期间的临床发现。在基线和治疗 6、12 和 24 个月时进行磁共振成像（MRI）扫描。将无疾病活动（即无复发、残疾进展、MRI 活动）的患者累积比例作为疗效终点进行测量。尽管基线特征表明我们的样本疾病严重程度比 AFFIRM 试验更高，但那他珠单抗的有效性数据具有可比性。在治疗 1 年时，我们发现分别有 80%和 70%的患者无复发和 MRI 活动，这与 AFFIRM 试验中检测到的 75%和 62%相似。此外，在平均 15 个月的随访时间后，我们的患者中只有 5%出现残疾进展。最后，抗那他珠单抗抗体的存在与复发（p = 0.002）和 MRI 活动（p < 0.001）的发生密切相关，即使是在上市后经验中也是如此。
