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在多发性硬化症的真实患者队列中,阿仑单抗的疗效和安全性。

Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis.

机构信息

Multiple Sclerosis Center, University of Cagliari/ATS Sardegna, Via Is Guadazzonis, 2, 09126, Cagliari, Italy.

出版信息

J Neurol. 2019 Jun;266(6):1405-1411. doi: 10.1007/s00415-019-09272-6. Epub 2019 Mar 12.

DOI:10.1007/s00415-019-09272-6
PMID:30863891
Abstract

BACKGROUND

No postmarketing randomised clinical trials are available about alemtuzumab, and real-world data are limited. We aimed to analyse the efficacy and safety of alemtuzumab in a single-centre cohort of patients with relapsing-remitting MS.

METHODS

Patients who took alemtuzumab were enrolled. We collected the following data: age, sex, MS history, expanded disability status scale (EDSS), relapses, magnetic resonance imaging (MRI) parameters after alemtuzumab, and adverse events. EDSS scores before alemtuzumab and at the last follow-up were compared by Wilcoxon test. Time to first relapse was analysed after dividing the cohort on the basis of previous treatment.

RESULTS

Ninety patients were enrolled [women 74.4%; naïve 7; mean follow-up 27 months (SD 23)]. The EDSS was reduced from a median of 2.5 (IQR 1.5-4) before alemtuzumab to 2.0 (IQR 1.5-3.5) after (p = 0.025). The time to first relapse was shorter in patients shifting from a second-line therapy (p = 0.011). Over 2 years, 43.7% had no evidence of disease activity. We observed infusion-related reactions in 95.5% patients, including 11.1% with pneumonitis, thyroiditis in 11%, and thrombocytopenia in 3.3%.

CONCLUSIONS

We confirmed the clinical and MRI efficacy of alemtuzumab in the clinical setting and the frequency of infusion-related reactions. Compared with that in clinical trials, higher number of patients developed pneumonitis during infusion.

摘要

背景

尚无关于阿仑单抗的上市后随机临床试验,且真实世界数据有限。我们旨在分析单中心队列中复发缓解型多发性硬化症患者使用阿仑单抗的疗效和安全性。

方法

纳入接受阿仑单抗治疗的患者。我们收集了以下数据:年龄、性别、多发性硬化症病史、扩展残疾状态量表(EDSS)评分、复发情况、阿仑单抗治疗后的磁共振成像(MRI)参数以及不良事件。采用 Wilcoxon 检验比较阿仑单抗治疗前和最后一次随访时的 EDSS 评分。根据既往治疗情况将队列分组,分析首次复发时间。

结果

共纳入 90 例患者[女性 74.4%;初治患者 7 例;平均随访 27 个月(SD 23 个月)]。阿仑单抗治疗前 EDSS 中位数为 2.5(IQR 1.5-4),治疗后降至 2.0(IQR 1.5-3.5)(p=0.025)。从二线治疗转为一线治疗的患者首次复发时间更短(p=0.011)。超过 2 年,43.7%的患者无疾病活动证据。我们观察到 95.5%的患者出现了输注相关反应,包括 11.1%的肺炎、11%的甲状腺炎和 3.3%的血小板减少症。

结论

我们在临床环境中证实了阿仑单抗的临床和 MRI 疗效以及输注相关反应的频率。与临床试验相比,更多患者在输注期间发生了肺炎。

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本文引用的文献

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Early neutropenia with thrombocytopenia following alemtuzumab treatment for multiple sclerosis: case report and review of literature.阿仑单抗治疗多发性硬化症后早期出现中性粒细胞减少伴血小板减少:病例报告及文献复习
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Lambert-Eaton myasthenic syndrome associated with alemtuzumab administration. Lambert-Eaton 肌无力综合征与阿仑单抗给药相关。
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No evidence of disease activity (NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis: a 36-month real-world study.
奥天时的阿仑单抗医治多发性软化症:一项观测性长时刻结局研讨。
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Risk of secondary autoimmune diseases with alemtuzumab treatment for multiple sclerosis: a systematic review and meta-analysis.来氟米特治疗多发性硬化症的安全性:系统评价和荟萃分析。
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Long-term follow up of alemtuzumab-treated patients: a retrospective study in a Belgian tertiary care center.阿仑单抗治疗患者的长期随访:比利时一家三级护理中心的回顾性研究
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Real-World Retrospective Analysis of Alemtuzumab Outcomes in Relapsing-Remitting Multiple Sclerosis: The LEMCAM Study.真实世界回顾性分析阿仑单抗治疗复发缓解型多发性硬化症的疗效:LEMCAM 研究。
CNS Drugs. 2024 Mar;38(3):231-238. doi: 10.1007/s40263-024-01066-3. Epub 2024 Feb 28.
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Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis.用于复发型多发性硬化症治疗的克拉屈滨片安全性专家叙述性综述
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Mult Scler Relat Disord. 2018 Oct;25:216-218. doi: 10.1016/j.msard.2018.08.006. Epub 2018 Aug 7.
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Clinical activity after fingolimod cessation: disease reactivation or rebound?停用地芬戈莫德后出现的临床活动:疾病再激活还是反弹?
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Alemtuzumab as rescue therapy in a cohort of 50 relapsing-remitting MS patients with breakthrough disease on fingolimod: a multi-center observational study.在接受芬戈莫德治疗的 50 例复发缓解型多发性硬化症患者中,阿仑单抗作为突破性疾病的挽救治疗:一项多中心观察性研究。
J Neurol. 2018 Jul;265(7):1521-1527. doi: 10.1007/s00415-018-8871-2. Epub 2018 Apr 25.
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Preapproval and postapproval evidence on drugs for multiple sclerosis.多发性硬化症药物的审批前和审批后证据。
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J Neurol. 2018 Nov;265(11):2494-2505. doi: 10.1007/s00415-018-8822-y. Epub 2018 Mar 10.
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