Retrospective, multi-centre, open-label study on the use of alemtuzumab for relapsing–remitting multiple sclerosis in clinical practice: A 4-year follow-up

A. Pato-Pato , P. Gabeiras-Araujo , M. Lorenzo-García , C. Hernandez-Cerón , J.R. Lorenzo-González , D.A. García-Estévez
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Abstract

Introduction

The efficacy and safety of alemtuzumab for patients with relapsing–remitting multiple sclerosis (RRMS) have been demonstrated in clinical trials. However, due to the limitations of these studies, it is important to assess the effects of the drug in clinical practice. The purpose of this study is to describe the effectiveness of alemtuzumab in terms of the number of relapses per year in patients with RRMS in the clinical setting. As secondary objectives, we evaluated its impact on disability and neuroimaging findings, as well as its tolerability and safety following administration.

Methods

We conducted a retrospective, multi-centre, open-label study by reviewing the clinical records of patients receiving alemtuzumab for RRMS treatment.

Results

A total of 32 patients were included at the beginning of the 4-year follow-up period. The mean number of relapses per year remained below 0.35 during follow-up, compared to 1.25 per year before treatment. Disability, as measured with the Expanded Disability Status Scale, improved during the first 2 years, and remained stable thereafter. Neuroimaging revealed a decrease in disease activity. The most frequent adverse effects were infusion-related reactions and infections.

Conclusions

Alemtuzumab has been shown to be effective in clinical practice in reducing the number of relapses per year, improving disability and decreasing disease activity on brain MRI in patients with MS, with adequate tolerability and safety. However, prevention and monitoring strategies continue to be necessary.
阿仑单抗治疗复发缓解型多发性硬化症临床实践的回顾性、多中心、开放标签研究:4年随访
导言:阿来姆珠单抗治疗复发性多发性硬化症(RRMS)患者的疗效和安全性已在临床试验中得到证实。然而,由于这些研究的局限性,评估该药物在临床实践中的效果非常重要。本研究旨在描述阿来珠单抗在临床环境中对 RRMS 患者每年复发次数的疗效。作为次要目标,我们评估了阿来珠单抗对残疾和神经影像学结果的影响,以及用药后的耐受性和安全性。方法我们通过回顾接受阿来珠单抗治疗RRMS患者的临床记录,开展了一项回顾性、多中心、开放标签研究。在随访期间,每年的平均复发次数保持在0.35次以下,而治疗前每年的复发次数为1.25次。用残疾状况扩展量表(Expanded Disability Status Scale)测量的残疾状况在头两年有所改善,之后保持稳定。神经影像学检查显示疾病活动有所减少。结论在临床实践中,阿来珠单抗已被证明能有效减少多发性硬化症患者每年的复发次数、改善残疾状况并降低脑部磁共振成像上的疾病活动性,而且具有足够的耐受性和安全性。然而,预防和监测策略仍然是必要的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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