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抗降钙素基因相关肽单克隆抗体之间转换的疗效与安全性:一项详细的月度及长期随访研究与文献综述

Efficacy and Safety of Switching between Anti-CGRP Monoclonal Antibodies: A Detailed Monthly and Long-term Follow-up Study and Literature Review.

作者信息

Oshima Kota, Ihara Keiko, Watanabe Narumi, Takemura Ryo, Ishizuchi Kei, Takahashi Nobuyuki, Shibata Mamoru, Nakahara Jin, Takizawa Tsubasa

机构信息

Department of Neurology, Keio University School of Medicine, Japan.

Japanese Red Cross Ashikaga Hospital, Japan.

出版信息

Intern Med. 2025 Jul 15;64(14):2114-2123. doi: 10.2169/internalmedicine.4360-24. Epub 2025 Jan 3.

DOI:10.2169/internalmedicine.4360-24
PMID:39756881
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12331329/
Abstract

Objective Switching from one anti-calcitonin gene-related peptide monoclonal antibody (CGRP mAb) to another can be beneficial for treating patients with migraine who do not respond well to the first CGRP mAb. However, detailed and long-term follow-up reports of both efficacy and safety remain insufficient. We conducted a case-series analysis of patients with migraine who switched from galcanezumab to erenumab, both belonging to the class of CGRP mAbs. Methods We conducted a single-center retrospective real-world study. Patients with migraine who first received galcanezumab for ≥3 months and then switched to erenumab at Keio University Hospital were enrolled to investigate changes in monthly migraine days (MMD), response rate, and adverse effects (e.g., injection-site reactions). Additionally, we performed a narrative review of the literature on switching CGRP mAbs. Results Among the nine patients enrolled, the 50% response rate for MMD was 33% at 3 months after switching. Two patients (22%) initially responded at the 3-month assessment, but later reverted to baseline MMD levels. Switching from galcanezumab to erenumab increased the frequency of constipation, which was typically managed using laxatives. Participants who experienced injection-site reactions tended to exhibit similar reactions regardless of the type of CGRP mAb used. Five patients (56%) demonstrated an improvement in satisfaction after erenumab initiation at least once. A literature review revealed that the characteristics of the cohorts varied among studies. Conclusion Switching from galcanezumab to erenumab was effective in some patients, while it was associated with some tolerable side effects, and it improved patient satisfaction in approximately half of the patients, despite interindividual diversity in responses and fluctuating responses after switching, which warrants further investigation.

摘要

目的 从一种抗降钙素基因相关肽单克隆抗体(CGRP单克隆抗体)换用另一种可能有助于治疗对第一种CGRP单克隆抗体反应不佳的偏头痛患者。然而,关于疗效和安全性的详细长期随访报告仍然不足。我们对从加卡尼单抗换用erenumab的偏头痛患者进行了病例系列分析,这两种药物均属于CGRP单克隆抗体类。方法 我们进行了一项单中心回顾性真实世界研究。纳入在庆应义塾大学医院首次接受加卡尼单抗治疗≥3个月,然后换用erenumab的偏头痛患者,以调查每月偏头痛天数(MMD)、缓解率和不良反应(如注射部位反应)的变化。此外,我们对关于换用CGRP单克隆抗体的文献进行了叙述性综述。结果 在纳入的9例患者中,换用后3个月时MMD的50%缓解率为33%。2例患者(22%)在3个月评估时最初有反应,但后来又恢复到基线MMD水平。从加卡尼单抗换用erenumab增加了便秘的发生率,通常使用泻药进行处理。经历注射部位反应的参与者无论使用何种CGRP单克隆抗体往往都会出现类似反应。5例患者(56%)在开始使用erenumab后至少有一次满意度有所提高。文献综述显示,不同研究中的队列特征各不相同。结论 从加卡尼单抗换用erenumab在一些患者中有效,同时伴有一些可耐受的副作用,并且在大约一半的患者中提高了患者满意度,尽管个体反应存在差异且换用后反应波动,这值得进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b1/12331329/2503361667a1/1349-7235-64-14-2114-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b1/12331329/fad8f51ba590/1349-7235-64-14-2114-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b1/12331329/1c038703a28f/1349-7235-64-14-2114-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b1/12331329/79581b417797/1349-7235-64-14-2114-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b1/12331329/2503361667a1/1349-7235-64-14-2114-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b1/12331329/fad8f51ba590/1349-7235-64-14-2114-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b1/12331329/1c038703a28f/1349-7235-64-14-2114-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b1/12331329/79581b417797/1349-7235-64-14-2114-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8b1/12331329/2503361667a1/1349-7235-64-14-2114-g004.jpg

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本文引用的文献

1
Switching CGRP(r) MoAbs in migraine: what evidence?偏头痛中 CGRP(r) 单抗的转换:有何证据?
Expert Opin Biol Ther. 2024 May;24(5):327-333. doi: 10.1080/14712598.2024.2354386. Epub 2024 May 14.
2
CGRP-monoclonal antibodies in Japan: insights from an online survey of physician members of the Japanese headache society.CGRP 单克隆抗体在日本:来自日本头痛学会医师成员在线调查的见解。
J Headache Pain. 2024 Mar 15;25(1):39. doi: 10.1186/s10194-024-01737-y.
3
Real-world effectiveness of erenumab in Japanese patients with migraine.
依瑞奈尤单抗在日本偏头痛患者中的真实世界疗效。
Heliyon. 2024 Feb 17;10(4):e26568. doi: 10.1016/j.heliyon.2024.e26568. eCollection 2024 Feb 29.
4
Effectiveness of Switching CGRP Monoclonal Antibodies in Non-Responder Patients in the UAE: A Retrospective Study.阿联酋无反应患者中转换降钙素基因相关肽单克隆抗体的有效性:一项回顾性研究。
Neurol Int. 2024 Feb 18;16(1):274-288. doi: 10.3390/neurolint16010019.
5
Switching anti-CGRP monoclonal antibodies in chronic migraine: real-world observations of erenumab, fremanezumab and galcanezumab.慢性偏头痛中抗降钙素基因相关肽单克隆抗体的转换:erenumab、fremanezumab和galcanezumab的真实世界观察
Eur J Hosp Pharm. 2025 Feb 21;32(2):178-185. doi: 10.1136/ejhpharm-2023-003779.
6
Switching from calcitonin gene-related peptide monoclonal antibody monthly to fremanezumab quarterly based on the patient's preferred dosing schedule.根据患者偏好的给药方案,将降钙素基因相关肽单克隆抗体的给药频率从每月一次改为每季度一次使用fremanezumab。
J Neurol Sci. 2023 Dec 15;455:122786. doi: 10.1016/j.jns.2023.122786. Epub 2023 Nov 13.
7
Response to letter: "Switching from calcitonin gene-related peptide monoclonal antibody monthly to fremanezumab quarterly based on the patient's preferred dosing schedule" by Suzuki et al.对铃木等人所著信件《基于患者偏好的给药方案,从每月一次降钙素基因相关肽单克隆抗体转换为每季度一次的夫雷西尤单抗》的回复
J Neurol Sci. 2023 Dec 15;455:122785. doi: 10.1016/j.jns.2023.122785. Epub 2023 Nov 13.
8
Real-world evidence of fremanezumab for treating migraine in Japan: a retrospective study.在日本,使用 fremanezumab 治疗偏头痛的真实世界证据:一项回顾性研究。
BMC Neurol. 2023 Nov 14;23(1):404. doi: 10.1186/s12883-023-03449-3.
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Switching between anti-calcitonin gene-related peptide monoclonal antibodies: A comparison of monthly and quarterly dosing.在降钙素基因相关肽单克隆抗体之间切换:每月和每季度给药的比较。
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Front Neurol. 2023 Jul 6;14:1220285. doi: 10.3389/fneur.2023.1220285. eCollection 2023.