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瑞玛奈珠单抗用于发作性和慢性偏头痛的耐受性综述

Review of Tolerability of Fremanezumab for Episodic and Chronic Migraine.

作者信息

Root Shane, Ahn Kevin, Kirsch Jack, Hoskin Justin L

机构信息

Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.

University of Arizona School of Medicine, Phoenix, AZ, USA.

出版信息

Neuropsychiatr Dis Treat. 2023 Feb 20;19:391-401. doi: 10.2147/NDT.S371686. eCollection 2023.


DOI:10.2147/NDT.S371686
PMID:36846598
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9951598/
Abstract

Calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) were the first class of medication specifically developed for the prevention of migraine. Fremanezumab is one of four CGRP mAbs currently available and is approved by the US Food and Drug Administration (FDA) for the preventative treatment of episodic and chronic migraines. This narrative review summarizes the history of fremanezumab development, the trials that led to its approval, and the later studies published evaluating its tolerability and efficacy. Evidence of fremanezumab for clinically significant efficacy and tolerability in patients with chronic migraine is especially important when considering the high level of disability, lower quality of life scores, and higher levels of health-care utilization associated with this condition. Multiple clinical trials demonstrated superiority of fremanezumab over placebo in terms of efficacy while demonstrating good tolerability. Treatment-related adverse reactions did not differ significantly compared to placebo and dropout rates were minimal. The most commonly observed treatment-related adverse reaction was mild-to-moderate injection site reaction, described as erythema, pain, induration, or swelling at the injection site.

摘要

降钙素基因相关肽(CGRP)单克隆抗体(mAbs)是首批专门开发用于预防偏头痛的药物。夫瑞那单抗是目前可用的四种CGRP单克隆抗体之一,已获得美国食品药品监督管理局(FDA)批准,用于发作性和慢性偏头痛的预防性治疗。本叙述性综述总结了夫瑞那单抗的研发历史、促成其获批的试验,以及后来发表的评估其耐受性和疗效的研究。考虑到慢性偏头痛患者的高度残疾、较低的生活质量评分以及较高的医疗保健利用率,夫瑞那单抗对慢性偏头痛患者具有临床显著疗效和耐受性的证据尤为重要。多项临床试验表明,夫瑞那单抗在疗效方面优于安慰剂,同时耐受性良好。与安慰剂相比,治疗相关不良反应无显著差异,脱落率极低。最常观察到的治疗相关不良反应是轻至中度注射部位反应,表现为注射部位的红斑、疼痛、硬结或肿胀。

相似文献

[1]
Review of Tolerability of Fremanezumab for Episodic and Chronic Migraine.

Neuropsychiatr Dis Treat. 2023-2-20

[2]
Monoclonal antibodies blocking CGRP transmission: An update on their added value in migraine prevention.

Rev Neurol (Paris). 2020-12

[3]
A head-to-head observational cohort study on the efficacy and safety of monoclonal antibodies against calcitonin gene-related peptide for chronic and episodic migraine.

Headache. 2023-6

[4]
Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study.

Drug Saf. 2021-12

[5]
Fremanezumab in the treatment of migraines: evidence to date.

J Pain Res. 2019-8-22

[6]
Efficacy and safety of fremanezumab in clinical trial participants aged ≥60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies.

J Headache Pain. 2021-11-24

[7]
History and Review of anti-Calcitonin Gene-Related Peptide (CGRP) Therapies: From Translational Research to Treatment.

Headache. 2018-9-22

[8]
Safety and Tolerability of Fremanezumab for the Prevention of Migraine: A Pooled Analysis of Phases 2b and 3 Clinical Trials.

Headache. 2019-4-12

[9]
Fremanezumab for the prevention of chronic and episodic migraine.

Drugs Today (Barc). 2019-4

[10]
Safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine - a meta-analysis of randomized controlled trials.

Cephalalgia. 2019-2-21

引用本文的文献

[1]
Exploring the Causal Relationship Between Migraine and Insomnia Through Bidirectional Two-Sample Mendelian Randomization: A Bidirectional Causal Relationship.

J Pain Res. 2024-7-16

[2]
CGRP Antagonism and Ketogenic Diet in the Treatment of Migraine.

Medicina (Kaunas). 2024-1-15

[3]
Efficacy and Safety of Anti-calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibodies in Preventing Migraines: A Systematic Review.

Cureus. 2023-9-19

[4]
Consensus-Based Recommendations on the Use of CGRP-Based Therapies for Migraine Prevention in the UAE.

Neurol Ther. 2023-12

本文引用的文献

[1]
Plasma Levels of CGRP During a 2-h Infusion of VIP in Healthy Volunteers and Patients With Migraine: An Exploratory Study.

Front Neurol. 2022-4-1

[2]
Comparative Effectiveness and Tolerability of the Pharmacology of Monoclonal Antibodies Targeting the Calcitonin Gene-Related Peptide and Its Receptor for the Prevention of Chronic Migraine: a Network Meta-analysis of Randomized Controlled Trials.

Neurotherapeutics. 2021-10

[3]
Effect of Vasoactive Intestinal Polypeptide on Development of Migraine Headaches: A Randomized Clinical Trial.

JAMA Netw Open. 2021-8-2

[4]
CGRP-antibodies, topiramate and botulinum toxin type A in episodic and chronic migraine: A systematic review and meta-analysis.

Cephalalgia. 2021-10

[5]
Real-World Evidence for Control of Chronic Migraine Patients Receiving CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA: A Retrospective Chart Review.

Pain Ther. 2021-12

[6]
Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database.

Cephalalgia. 2021-6

[7]
Hypertension: A new safety risk for patients treated with erenumab.

Headache. 2021-1

[8]
Botulinum Toxin in the Treatment of Headache.

Toxins (Basel). 2020-12-17

[9]
Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019.

J Headache Pain. 2020-12-2

[10]
Calcitonin Gene-Related Peptide Monoclonal Antibody Use for the Preventive Treatment of Refractory Headache Disorders in Adolescents.

Pediatr Neurol. 2021-1

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