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复发缓解型多发性硬化症患者抗CD20单克隆抗体降阶梯至低-中度疗效疾病修正治疗(DMTs):伊朗的初步经验。

De-escalation of anti-CD20 monoclonal antibodies to low-moderate efficacy disease-modifying treatments (DMTs) in patients with relapse-remitting multiple sclerosis: An initial Iranian experience.

作者信息

Paybast Sepideh, Rezaeimanesh Nasim, Naser Moghadasi Abdorreza

机构信息

Department of Neurology, Imam Hossein Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Multiple Sclerosis Research Center, Neuroscience Institute; Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Caspian J Intern Med. 2024 Oct 19;16(1):126-131. doi: 10.22088/cjim.16.1.126. eCollection 2025 Winter.

DOI:10.22088/cjim.16.1.126
PMID:39619757
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11607104/
Abstract

BACKGROUND

Anti-CD20 are among the high-efficacy DMTs commonly used in treating multiple sclerosis (MS). Long-term safety data on anti-CD20s are limited. There is convincing evidence of hypogammaglobulinemia in the long-term use of anti-CD20s, raising the likelihood of infection. Accordingly, there is an unmet need for de-escalation therapy in stable patients to reduce adverse events. Herein we aimed to describe our experience with ten relapse-remitting MS (RRMS) patients who were switched from anti-CD20s to the low-moderate efficacy DMTs.

METHODS

This cohort study was conducted between January 2020 and February 2023 at the MS Research Center of Sina Hospital, Tehran, Iran, to identify the characteristics of RRMS patients who were switched from anti-CD20s to low-moderate efficacy DMTs within 12 months of the last anti-CD20 infusion. Patients were then followed up to 18 months after de-escalation.

RESULTS

All patients were females, with a mean age of 39.3±2.53-year-old and a mean disease duration of 9.7±1.39 years. After a mean of 2.95±0.44 years of treatment with anti-CD20s, patients were de-escalated to INF-β1a (n=5), dimethyl fumarate (DMF) (n=3), fingolimod (n=1), and teriflunomide (n=1). The main reason for anti-CD20 discontinuation was an infectious concern. Within 18 months of follow-up, no patient developed clinical or MRI activity. Additionally, we did not find evidence of disability progression in any patients (P=0.13).

CONCLUSION

The present study is a real-world experience of de-escalating anti-CD20s to low-moderate efficacy DMTs, which suggests that at short-term follow-up, de-escalating anti-CD20s appeared to be effective and safe in RRMS patients.

摘要

背景

抗CD20药物是治疗多发性硬化症(MS)常用的高效疾病修正治疗药物(DMTs)。抗CD20药物的长期安全性数据有限。有令人信服的证据表明,长期使用抗CD20药物会导致低丙种球蛋白血症,增加感染的可能性。因此,对于病情稳定的患者,迫切需要采用降阶梯疗法以减少不良事件。在此,我们旨在描述10例复发缓解型MS(RRMS)患者从抗CD20药物转换为低-中度疗效DMTs的经验。

方法

本队列研究于2020年1月至2023年2月在伊朗德黑兰西娜医院的MS研究中心进行,以确定在最后一次输注抗CD20药物后12个月内从抗CD20药物转换为低-中度疗效DMTs的RRMS患者的特征。然后对患者进行随访,直至降阶梯治疗后18个月。

结果

所有患者均为女性,平均年龄为39.3±2.53岁,平均病程为9.7±1.39年。在用抗CD20药物平均治疗2.95±0.44年后,患者降阶梯至干扰素β-1a(n = 5)、富马酸二甲酯(DMF)(n = 3)、芬戈莫德(n = 1)和特立氟胺(n = 1)。停用抗CD20药物的主要原因是对感染的担忧。在随访的18个月内,没有患者出现临床或MRI活动。此外,我们没有发现任何患者有残疾进展的证据(P = 0.13)。

结论

本研究是抗CD20药物降阶梯至低-中度疗效DMTs的真实世界经验,表明在短期随访中,抗CD20药物降阶梯在RRMS患者中似乎是有效且安全的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1db7/11607104/33156a08a984/cjim-16-126-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1db7/11607104/4439e5e65e1c/cjim-16-126-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1db7/11607104/33156a08a984/cjim-16-126-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1db7/11607104/4439e5e65e1c/cjim-16-126-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1db7/11607104/33156a08a984/cjim-16-126-g002.jpg

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