Herman Jorge Acevedo, Khalighinejad Farnaz, York Katherine, Radu Irina, Berrios Morales Idanis, Ionete Carolina, Hemond Christopher C
University of Massachusetts Medical School, Department of Neurology, 55 Lake Avenue North, Worcester, MA, 01655, USA.
University of Massachusetts Medical School, Department of Neurology, 55 Lake Avenue North, Worcester, MA, 01655, USA.
Mult Scler Relat Disord. 2021 Jan;47:102619. doi: 10.1016/j.msard.2020.102619. Epub 2020 Nov 5.
Multiple sclerosis (MS) is a chronic and progressive neurological disease characterized by recurrent episodes of inflammatory demyelination of the brain and spinal cord. Alemtuzumab has been previously shown in large phase III trials to be an effective therapy in reducing MS clinical flares as well as new radiological activity and atrophy rates. The purpose of this study was to examine real-world effectiveness and safety data from a large cohort of people treated with alemtuzumab at an academic medical center, including those who failed B-cell depletion therapy. Over an average of 2.6 years follow-up, there were small but significant improvements in neurological disability scores, and a 61% rate of the composite "No Evidence of Disease Activity" (NEDA-3) outcome at 2-year follow-up. There were no substantial safety issues encountered in our review; rates of adverse events were similar or below those reported in Phase III trials. We compare and contrast our results to other available real-world data using alemtuzumab in multiple sclerosis.
多发性硬化症（MS）是一种慢性进行性神经疾病，其特征为脑和脊髓反复出现炎性脱髓鞘发作。先前在大型III期试验中已表明，阿仑单抗是一种有效的治疗方法，可减少MS临床发作以及新的影像学活动和萎缩率。本研究的目的是检查在一家学术医疗中心接受阿仑单抗治疗的一大群人的真实世界有效性和安全性数据，包括那些B细胞清除疗法失败的人。在平均2.6年的随访中，神经功能障碍评分有微小但显著的改善，在2年随访时复合“无疾病活动证据”（NEDA-3）结局的发生率为61%。在我们的综述中未遇到重大安全问题；不良事件发生率与III期试验报告的相似或更低。我们将我们的结果与其他使用阿仑单抗治疗多发性硬化症的可用真实世界数据进行比较和对比。
