降钙素基因相关肽单克隆抗体治疗高频发作性和慢性偏头痛

L. Dobrynina, M. A. Afanasev, A. Belopasova, M. Gubanova, E. V. Baydina
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引用次数: 0

摘要

介绍。偏头痛的高患病率及其对生活质量的影响需要开发原始药物。2020年,新型降钙素基因相关肽单克隆抗体fremanezumab在俄罗斯获批。目的:评价fremanezumab治疗高频发作性偏头痛(HF EM)和慢性偏头痛(CM)患者的安全性和有效性。材料和方法。我们评估了60例年龄35.5 - 8.96岁的HFEM和CM患者(85%,女性),有或没有先兆,接受或不接受预防性治疗。Fremanezumab单剂量675 mg皮下给药。随访3个月观察疗效。研究人员评估了每月头痛天数的变化、头痛强度、对日常活动、焦虑和抑郁的影响。结果。在给药后的第3个月结束时,76.7%的参与者头痛天数减少了50%,其中77.8%的人患有HF EM, 72.7%的人患有CM,所有患者的头痛强度均有所下降。15%的参与者报告无反应(头痛天数减少30%),其中包括14.8%的HF EM患者和15.2%的CM患者。在研究第3个月结束时,81%的参与者没有表现出焦虑症状,79%的参与者没有表现出抑郁,两组的MIDAS和HIT-6评分均显著下降。只有3例(5%)患者注意到不良事件(给药部位发红、瘙痒)。结论。与随机临床试验中的fremanezumab安全性和有效性相比,我们在现实世界的实践中记录了更高的fremanezumab在EM和CM患者中的安全性和有效性。单剂量fremanezumab (675 mg)可有效预防偏头痛,减少共病焦虑和抑郁,并在3个月的随访期间改善生活质量。
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The Management of High-Frequency Episodic and Chronic Migraines with Calcitonin Gene-Related Peptide Monoclonal Antibody
Introduction. High prevalence of migraine and its impact on quality of life requires the development of original agents. In 2020, fremanezumab, a new calcitonin gene-related peptide monoclonal antibody was authorized in Russia. Objective: to evaluate safety and effectiveness of fremanezumab in patients with high-frequency episodic migraine (HF EM) and chronic migraine (CM). Materials and methods. We assessed 60 patients at the age of 35.5 8.96 years (85%, females) with HFEM and CM with and without aura who were either receiving preventive treatment or not. Fremanezumab was administered subcutaneously at a single dose of 675 mg. The study participants were followed-up for efficacy in 3 months. The investigators assessed change in the number of days with headache per month as well as headache intensity, its impact on the daily activities, anxiety, and depression. Results. By the end of month 3 post dosing, the number of days with headache decreased by 50% in 76.7% of participants where 77.8% of individuals suffered from HF EM and 72.7% of individuals had CM while headache intensity decreased in all the patients equally. No response (decrease in the number of days with headache by 30%) was reported in 15% of participants including 14.8% of individuals with HF EM and 15.2% of individuals with CM. By the end of study month 3, 81% of participants demonstrated no anxiety symptoms and 79% of participants showed no depression with significant MIDAS and HIT-6 score decline in both groups. Only 3 (5%) patients noted adverse events (redness, itching at the administration site). Conclusion. We documented higher fremanezumab safety and effectiveness in patients with EM and CM in real-world practice as compared to fremanezumab safety and efficacy in randomized clinical trials. A single dose of fremanezumab (675 mg) resulted in effective migraine prevention, decline in comorbid anxiety and depression, and improved quality of life during 3-month follow-up.
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来源期刊
Annals of Clinical and Experimental Neurology
Annals of Clinical and Experimental Neurology Medicine-Neurology (clinical)
CiteScore
0.80
自引率
0.00%
发文量
32
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