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在复发缓解型多发性硬化症中停用芬戈莫德后,用阿仑单抗或利妥昔单抗治疗是有效和安全的。

Treatment with alemtuzumab or rituximab after fingolimod withdrawal in relapsing-remitting multiple sclerosis is effective and safe.

机构信息

Department of Neurology, La Fe Hospital, 106 Avenue Fernando Abril Martorell, 46026, Valencia, Spain.

Department of Neurology, Clinic Hospital, Valencia, Spain.

出版信息

J Neurol. 2019 Mar;266(3):726-734. doi: 10.1007/s00415-019-09195-2. Epub 2019 Jan 19.

Abstract

BACKGROUND

It has been described that treating relapsing-remitting multiple sclerosis (RRMS) patients with alemtuzumab following fingolimod could be less effective due to the different dynamics of lymphocyte repopulation. Effectiveness and safety of alemtuzumab compared to rituximab after fingolimod withdrawal were analyzed.

PATIENTS AND METHODS

A follow-up of a cohort of RRMS patients treated with alemtuzumab or rituximab after fingolimod withdrawal was accomplished. Effectiveness, measured by the percentage of patients with no evidence of disease activity (NEDA), and the presence of side effects (SE) were registered.

RESULTS

Fifty-five patients, 28 with alemtuzumab and 27 with rituximab, were analyzed. No differences in the washout period or in the baseline lymphocytes counts were observed. After a mean follow-up period of 28.8 months, the annualized relapsing rate was significantly reduced in the alemtuzumab group from 1.29 to 0.004 (p < 0.001) and in the rituximab group from 1.24 to 0.02 (p < 0.001), without differences. A significant reduction of the median EDSS from 2.8 to 2.0 in the alemtuzumab group and from 3.5 to 2.5 (p < 0.01) in the rituximab group was observed, without differences. Eighty-two per cent (n = 28) of patients in alemtuzumab group and 69.2% (n = 26) in rituximab group achieved NEDA criteria, without differences (p = 0.3). Symptoms related to the infusion were the most frequent SE in both groups. No serious SE were registered.

CONCLUSION

Treating RRMS patients with alemtuzumab or rituximab after fingolimod withdrawal is effective and safe, without significant differences between both groups in our series.

摘要

背景

据报道,由于淋巴细胞再增殖动力学不同,用阿仑单抗治疗继发性缓解型多发性硬化症(RRMS)患者在接受芬戈莫德治疗后可能效果较差。分析了阿仑单抗与利妥昔单抗在停用芬戈莫德后的疗效和安全性。

患者和方法

对接受阿仑单抗或利妥昔单抗治疗继发性缓解型多发性硬化症患者进行了芬戈莫德停药后的随访。记录了无疾病活动证据(NEDA)的患者比例和不良反应(SE)的有效性。

结果

共分析了 55 例患者,其中 28 例接受阿仑单抗治疗,27 例接受利妥昔单抗治疗。在冲洗期或基线淋巴细胞计数方面无差异。平均随访 28.8 个月后,阿仑单抗组的年复发率从 1.29 降至 0.004(p<0.001),利妥昔单抗组从 1.24 降至 0.02(p<0.001),无差异。阿仑单抗组的中位数 EDSS 从 2.8 降至 2.0,利妥昔单抗组从 3.5 降至 2.5(p<0.01),无差异。阿仑单抗组 82%(n=28)的患者和利妥昔单抗组 69.2%(n=26)的患者达到了 NEDA 标准,无差异(p=0.3)。两组最常见的 SE 是与输液相关的症状。未记录到严重 SE。

结论

在本系列中,继发性缓解型多发性硬化症患者在停用芬戈莫德后用阿仑单抗或利妥昔单抗治疗是有效和安全的,两组之间无显著差异。

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