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Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials

Background: Fremanezumab (TEV-48125) is a fully-humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of the novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological dis...

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Autores principales: Gao, Bixi, Sun, Nan, Yang, Yanbo, Sun, Yue, Chen, Mingjia, Chen, Zhouqing, Wang, Zhong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7248404/
https://www.ncbi.nlm.nih.gov/pubmed/32508742
http://dx.doi.org/10.3389/fneur.2020.00435
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author Gao, Bixi
Sun, Nan
Yang, Yanbo
Sun, Yue
Chen, Mingjia
Chen, Zhouqing
Wang, Zhong
author_facet Gao, Bixi
Sun, Nan
Yang, Yanbo
Sun, Yue
Chen, Mingjia
Chen, Zhouqing
Wang, Zhong
author_sort Gao, Bixi
collection PubMed
description Background: Fremanezumab (TEV-48125) is a fully-humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of the novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological diseases worldwide. Several controlled trials have been conducted to investigate the safety and efficacy of fremanezumab, however, there is no systematic review of the existing literature has been performed. Hence, in our study, we performed a meta-analysis to investigate the safety and efficacy of fremanezumab for the prevention of migraine. Method: Pubmed (MEDLINE), Embase, and Cochrane Library were searched from January 2001 to August 2019 for randomized controlled trials (RCTs). Five RCTs with 3,379 patients were finally included in our study. Result: We pooled 3,379 patients from 5 RCTs; the primary endpoints were mean monthly migraine and headache days, baseline to week 12. We found that fremanezumab led to a significant reduction in migraine days (P < 0.0001) and headache days (P < 0.0001) during 12 weeks compared with placebo. Moreover, after using fremanezumab, the risk of at least one adverse event (AE) (P = 0.001) and AE related to the trial regimen (P = 0.0005) significantly increased compared with the placebo. Conclusions: Fremanezumab showed good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but no serious adverse events.
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spelling pubmed-72484042020-06-05 Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials Gao, Bixi Sun, Nan Yang, Yanbo Sun, Yue Chen, Mingjia Chen, Zhouqing Wang, Zhong Front Neurol Neurology Background: Fremanezumab (TEV-48125) is a fully-humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of the novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological diseases worldwide. Several controlled trials have been conducted to investigate the safety and efficacy of fremanezumab, however, there is no systematic review of the existing literature has been performed. Hence, in our study, we performed a meta-analysis to investigate the safety and efficacy of fremanezumab for the prevention of migraine. Method: Pubmed (MEDLINE), Embase, and Cochrane Library were searched from January 2001 to August 2019 for randomized controlled trials (RCTs). Five RCTs with 3,379 patients were finally included in our study. Result: We pooled 3,379 patients from 5 RCTs; the primary endpoints were mean monthly migraine and headache days, baseline to week 12. We found that fremanezumab led to a significant reduction in migraine days (P < 0.0001) and headache days (P < 0.0001) during 12 weeks compared with placebo. Moreover, after using fremanezumab, the risk of at least one adverse event (AE) (P = 0.001) and AE related to the trial regimen (P = 0.0005) significantly increased compared with the placebo. Conclusions: Fremanezumab showed good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but no serious adverse events. Frontiers Media S.A. 2020-05-19 /pmc/articles/PMC7248404/ /pubmed/32508742 http://dx.doi.org/10.3389/fneur.2020.00435 Text en Copyright © 2020 Gao, Sun, Yang, Sun, Chen, Chen and Wang. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Gao, Bixi
Sun, Nan
Yang, Yanbo
Sun, Yue
Chen, Mingjia
Chen, Zhouqing
Wang, Zhong
Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials
title Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials
title_full Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials
title_fullStr Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials
title_full_unstemmed Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials
title_short Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials
title_sort safety and efficacy of fremanezumab for the prevention of migraine: a meta-analysis from randomized controlled trials
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7248404/
https://www.ncbi.nlm.nih.gov/pubmed/32508742
http://dx.doi.org/10.3389/fneur.2020.00435
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