Cantonal Hospital, St. Gallen, Switzerland.
Ther Adv Neurol Disord. 2009 Mar;2(2):115-28. doi: 10.1177/1756285608101861.
Natalizumab reduced the rate of clinical relapse at one year by 68% and the risk of sustained progression of disability by 42-54% over 2 years in its pivotal phase III trial (AFFIRM) in relapsing-remitting multiple sclerosis (RRMS). Natalizumab is generally well tolerated, but due to rare and potentially fatal side-effects, it was approved with a restricted-distribution format in 2006. Expert statements and the European Medical Agency recommend the use of natalizumab after failure of first-line disease-modifying therapies in patients with relapsing forms of MS. As part of the risk management plan, worldwide extensive safety programmes aim to provide more data on natalizumab safety in clinical practice. At the end of September 2008, 48 000 patients have received natalizumab and 18000 patients are on treatment for at least 1 year. The assessment of risk and benefit is still ongoing.
那他珠单抗在 III 期关键性临床试验（AFFIRM）中使复发缓解型多发性硬化症（RRMS）患者的一年临床复发率降低了 68%，两年持续残疾进展的风险降低了 42-54%。那他珠单抗通常具有良好的耐受性，但由于罕见且可能致命的副作用，它于 2006 年以限制分发的形式获得批准。专家声明和欧洲药品管理局建议在复发型 MS 患者一线疾病修正治疗失败后使用那他珠单抗。作为风险管理计划的一部分，全球广泛的安全计划旨在提供更多那他珠单抗在临床实践中的安全性数据。截至 2008 年 9 月底，已有 48000 名患者接受了那他珠单抗治疗，18000 名患者的治疗时间至少为 1 年。风险和收益的评估仍在进行中。
