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在复发缓解型多发性硬化症中,使用单次环磷酰胺诱导疾病缓解。

Induction of disease remission with one cycle of alemtuzumab in relapsing-remitting MS.

机构信息

Division of Neurology, New York-Presbyterian/Weill Cornell Medicine, 1305 York Avenue, Suite Y-217, New York, NY, 10021, USA.

Touro College of Osteopathic Medicine, 60 Prospect Avenue, Middletown, NY, 10940, USA.

出版信息

J Neurol. 2018 May;265(5):1226-1229. doi: 10.1007/s00415-018-8845-4. Epub 2018 Apr 17.

DOI:10.1007/s00415-018-8845-4
PMID:29666985
Abstract

OBJECTIVE

To investigate a single-course treatment with alemtuzumab in patients with relapsing-remitting multiple sclerosis.

METHODS

We performed a retrospective chart review of all patients diagnosed with RRMS who were treated with alemtuzumab at our MS center and who had at least 12 month follow-up since the first dose. Data on radiological and clinical relapse were collected for the 2 years prior to patients' first dose of alemtuzumab and were tracked until the time of analysis.

RESULTS

In the 2 years prior to first dose of alemtuzumab, 82.8% of the 29 patients had a new lesion on MRI and/or a clinical relapse, with an ARR of 0.67. In the mean 24.7 month follow-up after the first dose of alemtuzumab, 17.2% of patients displayed new disease activity and the ARR was 0.08. 4 out of 5 patients who relapsed did so within 12 month post-first infusion and received a second dose. Of the 24 patients who did not relapse, 8 received a second dose at 1 year and 16 did not. 5 out of all 29 patients developed thyroid disorder.

CONCLUSIONS

Given that 96% of patients who did not relapse in the first 12 months following the initial dose of alemtuzumab remained relapse-free regardless of receiving a second course of drug, our data suggests that induction of disease remission for some patients might occur following just one dose of alemtuzumab. With further study, these data could support modification of the current therapy regimen.

摘要

目的

研究单次使用阿仑单抗治疗复发缓解型多发性硬化症患者的效果。

方法

我们对在我们的多发性硬化症中心接受阿仑单抗治疗且在首次给药后至少有 12 个月随访的所有 RRMS 患者进行了回顾性图表审查。在患者首次接受阿仑单抗治疗前的 2 年内收集了影像学和临床复发的数据,并跟踪至分析时。

结果

在首次接受阿仑单抗治疗前的 2 年内,29 例患者中有 82.8%的患者在 MRI 上有新病变和/或临床复发,ARR 为 0.67。在首次接受阿仑单抗治疗后的平均 24.7 个月随访中,17.2%的患者出现新的疾病活动,ARR 为 0.08。在复发的 5 例患者中有 4 例在首次输注后 12 个月内复发,并接受了第二次剂量。在未复发的 24 例患者中,有 8 例在 1 年后接受了第二次剂量,而 16 例没有。在所有 29 例患者中,有 5 例发生了甲状腺疾病。

结论

鉴于在首次接受阿仑单抗治疗后的前 12 个月内未复发的 96%的患者无论是否接受第二疗程药物治疗均未复发,我们的数据表明,对于某些患者,单次使用阿仑单抗可能会诱导疾病缓解。进一步的研究可以支持对当前治疗方案的修改。

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本文引用的文献

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Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings.阿仑单抗治疗复发型多发性硬化症(CARE-MS II)5年随访:疗效与安全性结果
Neurology. 2017 Sep 12;89(11):1117-1126. doi: 10.1212/WNL.0000000000004354. Epub 2017 Aug 23.
2
Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy.阿仑单抗治疗复发型多发性硬化症(CARE-MS I)5年随访:在未持续进行多发性硬化症治疗的情况下具有持久疗效。
Neurology. 2017 Sep 12;89(11):1107-1116. doi: 10.1212/WNL.0000000000004313. Epub 2017 Aug 23.
3
Review of the Clinical Pharmacokinetics and Pharmacodynamics of Alemtuzumab and Its Use in Kidney Transplantation.
回顾阿仑单抗的临床药代动力学和药效学及其在肾移植中的应用。
Clin Pharmacokinet. 2018 Feb;57(2):191-207. doi: 10.1007/s40262-017-0573-x.
4
Alemtuzumab consolidation in chronic lymphocytic leukaemia: a phase I/II multicentre trial.阿仑单抗用于慢性淋巴细胞白血病的巩固治疗:一项I/II期多中心试验
Eur J Haematol. 2017 Mar;98(3):254-262. doi: 10.1111/ejh.12825. Epub 2016 Dec 1.
5
Alemtuzumab (anti-CD52 monoclonal antibody) as single-agent therapy in patients with relapsed/refractory chronic lymphocytic leukaemia (CLL)-a single region experience on consecutive patients.阿仑单抗(抗CD52单克隆抗体)作为复发/难治性慢性淋巴细胞白血病(CLL)患者的单药治疗——对连续患者的单区域经验
Ann Hematol. 2014 Oct;93(10):1725-33. doi: 10.1007/s00277-014-2105-1. Epub 2014 May 21.
6
Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.阿仑单抗与干扰素β1a 作为复发缓解型多发性硬化症一线治疗的比较:一项随机对照 3 期试验。
Lancet. 2012 Nov 24;380(9856):1819-28. doi: 10.1016/S0140-6736(12)61769-3. Epub 2012 Nov 1.
7
Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial.阿仑单抗治疗缓解复发型多发性硬化症患者:一项疾病修饰治疗后随机对照 3 期试验。
Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1.
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Leukemia. 2009 Nov;23(11):1980-8. doi: 10.1038/leu.2009.146. Epub 2009 Jul 23.