Fernandez Oscar
Institute of Clinical Neuroscience, Neurology Department, Hospital Regional Universitario Carlos Haya, FIMABIS, Malaga, Spain.
J Inflamm Res. 2014 Feb 12;7:19-27. doi: 10.2147/JIR.S38079. eCollection 2014.
Alemtuzumab (formerly known as Campath-1H) has recently been approved by the European Medicines Agency for highly-active, relapsing-remitting multiple sclerosis (MS). The molecule targets the CD52 surface glycoprotein on certain T cells and B cells and is thought to exert its effect in MS through a "resetting" of the lymphocyte population. Approval was granted on the strength of two pivotal studies, Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis (CARE-MS)-1 in the first-line setting and CARE-MS-2 in patients who had failed first-line therapy. In both studies, alemtuzumab significantly reduced the relapse rate compared to the comparator, interferon beta-1a (44 μg) given subcutaneously three-times per week (Rebif®). In the first-line study, alemtuzumab was also found to significantly reduce the number of patients with sustained progression compared to interferon beta-1a therapy. Autoimmune disorders represent the major side effect of alemtuzumab therapy although they can be managed by careful monitoring and early treatment. Overall, alemtuzumab is likely to be a valuable addition to the neurologist's armamentarium for the treatment of relapsing-remitting MS.
阿仑单抗(曾用名Campath-1H)最近已获欧洲药品管理局批准,用于治疗高度活跃的复发缓解型多发性硬化症(MS)。该药物作用于某些T细胞和B细胞表面的CD52糖蛋白,被认为通过“重置”淋巴细胞群在MS中发挥作用。基于两项关键研究获批,一项是一线治疗中的阿仑单抗与利比®(Rebif®)治疗多发性硬化症疗效比较(CARE-MS)-1研究,另一项是一线治疗失败患者的CARE-MS-2研究。在这两项研究中,与对照药物皮下每周三次注射44μg的干扰素β-1a(利比®)相比,阿仑单抗显著降低了复发率。在一线治疗研究中,与干扰素β-1a治疗相比,还发现阿仑单抗显著减少了持续进展患者的数量。自身免疫性疾病是阿仑单抗治疗的主要副作用,不过可通过密切监测和早期治疗加以控制。总体而言,阿仑单抗可能会成为神经科医生治疗复发缓解型MS的有效药物。