Safety and efficacy of galcanezumab in chronic and episodic migraine patients: a systematic review and meta-analysis of randomized controlled trials

Background The humanized monoclonal antibody galcanezumab is an anti-calcitonin-gene-related-peptide (CGRP) and frequently used for migraine prevention. However, the literature revealed limited data with conflicting results. This study aims to assess the safety and efficacy of galcanezumab in treati...

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Veröffentlicht in:The Egyptian Journal of Neurology, Psychiatry and Neurosurgery Psychiatry and Neurosurgery, 2024-05, Vol.60 (1), p.60-15, Article 60
Hauptverfasser: Zaazouee, Mohamed Sayed, Ebrahim, Rokaya Y., Al-araj, Ghaida’a, Zaki, Ibram, Saad, Ahmed, Farhat, Abdullah Mohamed, Ali, Mustafa Hussein, Elshennawy, Mohamed, Fawy, Omar Khaled Fahmy, Ahmed, Hadi F., Alahmad, Ziad, Nada, Eman Ayman, Abo-Hamra, Reem I., Elsnhory, Ahmed Bostamy, Eleyan, Mohammed, AbuEl-Enien, Hazem, Elromely, Rasha Abdo, AbdelQadir, Yossef Hassan, Shah, Jaffer, Elshanbary, Alaa Ahmed
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container_issue 1
container_start_page 60
container_title The Egyptian Journal of Neurology, Psychiatry and Neurosurgery
container_volume 60
creator Zaazouee, Mohamed Sayed
Ebrahim, Rokaya Y.
Al-araj, Ghaida’a
Zaki, Ibram
Saad, Ahmed
Farhat, Abdullah Mohamed
Ali, Mustafa Hussein
Elshennawy, Mohamed
Fawy, Omar Khaled Fahmy
Ahmed, Hadi F.
Alahmad, Ziad
Nada, Eman Ayman
Abo-Hamra, Reem I.
Elsnhory, Ahmed Bostamy
Eleyan, Mohammed
AbuEl-Enien, Hazem
Elromely, Rasha Abdo
AbdelQadir, Yossef Hassan
Shah, Jaffer
Elshanbary, Alaa Ahmed
description Background The humanized monoclonal antibody galcanezumab is an anti-calcitonin-gene-related-peptide (CGRP) and frequently used for migraine prevention. However, the literature revealed limited data with conflicting results. This study aims to assess the safety and efficacy of galcanezumab in treating patients with episodic or chronic migraine. Methods We searched for randomized controlled trials till September 2022 from six databases (Cochrane library, Embase, PubMed, Web of Science, Scopus, and Clinicaltrials.gov registry). Our primary outcomes were the change in the number of monthly migraine headache days (MHDs) and adverse events. We extracted the data and analyzed it by RevMan (5.4) software. Results Eight studies with 4964 patients were included. Galcanezumab (≥ 120 mg) significantly reduced the MHDs for six months in migraine patients compared to placebo. The monthly risk ratio (RR) ranged from − 2.33 to − 1.62 for episodic migraine and − 2.86 to − 2.44 for chronic migraine. The response rate of ≥ 50%, ≥ 75% and 100% were higher with galcanezumab groups. The rate ranged from 1.72 to 4.19 for episodic migraine and 1.84 to 2.47 for chronic migraine. It is generally safe except for injection site safety outcomes (erythema, reaction, pruritis, and swelling), the results were significantly higher with galcanezumab groups. It appears dose independent except for injection site reaction, which showed higher with galcanezumab 120 mg only. Furthermore, any adverse events, serious adverse events (SAE) and that led to discontinuation were higher with galcanezumab 240 mg. Conclusion Galcanezumab is effective in patients with episodic or chronic migraine after one to six months use. It reduced MHDs and had an effective response rate. Moreover, it is generally safe except for injection site adverse events, and SAE, especially with galcanezumab 240mg.
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However, the literature revealed limited data with conflicting results. This study aims to assess the safety and efficacy of galcanezumab in treating patients with episodic or chronic migraine. Methods We searched for randomized controlled trials till September 2022 from six databases (Cochrane library, Embase, PubMed, Web of Science, Scopus, and Clinicaltrials.gov registry). Our primary outcomes were the change in the number of monthly migraine headache days (MHDs) and adverse events. We extracted the data and analyzed it by RevMan (5.4) software. Results Eight studies with 4964 patients were included. Galcanezumab (≥ 120 mg) significantly reduced the MHDs for six months in migraine patients compared to placebo. The monthly risk ratio (RR) ranged from − 2.33 to − 1.62 for episodic migraine and − 2.86 to − 2.44 for chronic migraine. The response rate of ≥ 50%, ≥ 75% and 100% were higher with galcanezumab groups. The rate ranged from 1.72 to 4.19 for episodic migraine and 1.84 to 2.47 for chronic migraine. It is generally safe except for injection site safety outcomes (erythema, reaction, pruritis, and swelling), the results were significantly higher with galcanezumab groups. It appears dose independent except for injection site reaction, which showed higher with galcanezumab 120 mg only. Furthermore, any adverse events, serious adverse events (SAE) and that led to discontinuation were higher with galcanezumab 240 mg. Conclusion Galcanezumab is effective in patients with episodic or chronic migraine after one to six months use. It reduced MHDs and had an effective response rate. Moreover, it is generally safe except for injection site adverse events, and SAE, especially with galcanezumab 240mg.</description><identifier>ISSN: 1687-8329</identifier><identifier>ISSN: 1110-1083</identifier><identifier>EISSN: 1687-8329</identifier><identifier>DOI: 10.1186/s41983-024-00834-8</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Clinical trials ; Galcanezumab ; Headache ; LY2951742 ; Medicine ; Medicine &amp; Public Health ; Meta-analysis ; Migraine ; Monoclonal antibodies ; Neurology ; Neurosurgery ; Psychiatry ; Response rates ; Review ; Systematic review</subject><ispartof>The Egyptian Journal of Neurology, Psychiatry and Neurosurgery, 2024-05, Vol.60 (1), p.60-15, Article 60</ispartof><rights>The Author(s) 2024</rights><rights>The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c380t-a0d04e0e4b57407857dc553da73c84a37b2b3b316197fea8dfddede6e5c760133</cites><orcidid>0000-0003-0904-9153</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,860,27903,27904</link.rule.ids></links><search><creatorcontrib>Zaazouee, Mohamed Sayed</creatorcontrib><creatorcontrib>Ebrahim, Rokaya Y.</creatorcontrib><creatorcontrib>Al-araj, Ghaida’a</creatorcontrib><creatorcontrib>Zaki, Ibram</creatorcontrib><creatorcontrib>Saad, Ahmed</creatorcontrib><creatorcontrib>Farhat, Abdullah Mohamed</creatorcontrib><creatorcontrib>Ali, Mustafa Hussein</creatorcontrib><creatorcontrib>Elshennawy, Mohamed</creatorcontrib><creatorcontrib>Fawy, Omar Khaled Fahmy</creatorcontrib><creatorcontrib>Ahmed, Hadi F.</creatorcontrib><creatorcontrib>Alahmad, Ziad</creatorcontrib><creatorcontrib>Nada, Eman Ayman</creatorcontrib><creatorcontrib>Abo-Hamra, Reem I.</creatorcontrib><creatorcontrib>Elsnhory, Ahmed Bostamy</creatorcontrib><creatorcontrib>Eleyan, Mohammed</creatorcontrib><creatorcontrib>AbuEl-Enien, Hazem</creatorcontrib><creatorcontrib>Elromely, Rasha Abdo</creatorcontrib><creatorcontrib>AbdelQadir, Yossef Hassan</creatorcontrib><creatorcontrib>Shah, Jaffer</creatorcontrib><creatorcontrib>Elshanbary, Alaa Ahmed</creatorcontrib><title>Safety and efficacy of galcanezumab in chronic and episodic migraine patients: a systematic review and meta-analysis of randomized controlled trials</title><title>The Egyptian Journal of Neurology, Psychiatry and Neurosurgery</title><addtitle>Egypt J Neurol Psychiatry Neurosurg</addtitle><description>Background The humanized monoclonal antibody galcanezumab is an anti-calcitonin-gene-related-peptide (CGRP) and frequently used for migraine prevention. However, the literature revealed limited data with conflicting results. This study aims to assess the safety and efficacy of galcanezumab in treating patients with episodic or chronic migraine. Methods We searched for randomized controlled trials till September 2022 from six databases (Cochrane library, Embase, PubMed, Web of Science, Scopus, and Clinicaltrials.gov registry). Our primary outcomes were the change in the number of monthly migraine headache days (MHDs) and adverse events. We extracted the data and analyzed it by RevMan (5.4) software. Results Eight studies with 4964 patients were included. Galcanezumab (≥ 120 mg) significantly reduced the MHDs for six months in migraine patients compared to placebo. The monthly risk ratio (RR) ranged from − 2.33 to − 1.62 for episodic migraine and − 2.86 to − 2.44 for chronic migraine. The response rate of ≥ 50%, ≥ 75% and 100% were higher with galcanezumab groups. The rate ranged from 1.72 to 4.19 for episodic migraine and 1.84 to 2.47 for chronic migraine. It is generally safe except for injection site safety outcomes (erythema, reaction, pruritis, and swelling), the results were significantly higher with galcanezumab groups. It appears dose independent except for injection site reaction, which showed higher with galcanezumab 120 mg only. Furthermore, any adverse events, serious adverse events (SAE) and that led to discontinuation were higher with galcanezumab 240 mg. Conclusion Galcanezumab is effective in patients with episodic or chronic migraine after one to six months use. It reduced MHDs and had an effective response rate. 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Ebrahim, Rokaya Y. ; Al-araj, Ghaida’a ; Zaki, Ibram ; Saad, Ahmed ; Farhat, Abdullah Mohamed ; Ali, Mustafa Hussein ; Elshennawy, Mohamed ; Fawy, Omar Khaled Fahmy ; Ahmed, Hadi F. ; Alahmad, Ziad ; Nada, Eman Ayman ; Abo-Hamra, Reem I. ; Elsnhory, Ahmed Bostamy ; Eleyan, Mohammed ; AbuEl-Enien, Hazem ; Elromely, Rasha Abdo ; AbdelQadir, Yossef Hassan ; Shah, Jaffer ; Elshanbary, Alaa Ahmed</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c380t-a0d04e0e4b57407857dc553da73c84a37b2b3b316197fea8dfddede6e5c760133</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Clinical trials</topic><topic>Galcanezumab</topic><topic>Headache</topic><topic>LY2951742</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Meta-analysis</topic><topic>Migraine</topic><topic>Monoclonal antibodies</topic><topic>Neurology</topic><topic>Neurosurgery</topic><topic>Psychiatry</topic><topic>Response rates</topic><topic>Review</topic><topic>Systematic review</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zaazouee, Mohamed Sayed</creatorcontrib><creatorcontrib>Ebrahim, Rokaya Y.</creatorcontrib><creatorcontrib>Al-araj, Ghaida’a</creatorcontrib><creatorcontrib>Zaki, Ibram</creatorcontrib><creatorcontrib>Saad, Ahmed</creatorcontrib><creatorcontrib>Farhat, Abdullah Mohamed</creatorcontrib><creatorcontrib>Ali, Mustafa Hussein</creatorcontrib><creatorcontrib>Elshennawy, Mohamed</creatorcontrib><creatorcontrib>Fawy, Omar Khaled Fahmy</creatorcontrib><creatorcontrib>Ahmed, Hadi F.</creatorcontrib><creatorcontrib>Alahmad, Ziad</creatorcontrib><creatorcontrib>Nada, Eman Ayman</creatorcontrib><creatorcontrib>Abo-Hamra, Reem I.</creatorcontrib><creatorcontrib>Elsnhory, Ahmed Bostamy</creatorcontrib><creatorcontrib>Eleyan, Mohammed</creatorcontrib><creatorcontrib>AbuEl-Enien, Hazem</creatorcontrib><creatorcontrib>Elromely, Rasha Abdo</creatorcontrib><creatorcontrib>AbdelQadir, Yossef Hassan</creatorcontrib><creatorcontrib>Shah, Jaffer</creatorcontrib><creatorcontrib>Elshanbary, Alaa Ahmed</creatorcontrib><collection>Springer Open Access</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health Medical collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health &amp; 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However, the literature revealed limited data with conflicting results. This study aims to assess the safety and efficacy of galcanezumab in treating patients with episodic or chronic migraine. Methods We searched for randomized controlled trials till September 2022 from six databases (Cochrane library, Embase, PubMed, Web of Science, Scopus, and Clinicaltrials.gov registry). Our primary outcomes were the change in the number of monthly migraine headache days (MHDs) and adverse events. We extracted the data and analyzed it by RevMan (5.4) software. Results Eight studies with 4964 patients were included. Galcanezumab (≥ 120 mg) significantly reduced the MHDs for six months in migraine patients compared to placebo. The monthly risk ratio (RR) ranged from − 2.33 to − 1.62 for episodic migraine and − 2.86 to − 2.44 for chronic migraine. The response rate of ≥ 50%, ≥ 75% and 100% were higher with galcanezumab groups. The rate ranged from 1.72 to 4.19 for episodic migraine and 1.84 to 2.47 for chronic migraine. It is generally safe except for injection site safety outcomes (erythema, reaction, pruritis, and swelling), the results were significantly higher with galcanezumab groups. It appears dose independent except for injection site reaction, which showed higher with galcanezumab 120 mg only. Furthermore, any adverse events, serious adverse events (SAE) and that led to discontinuation were higher with galcanezumab 240 mg. Conclusion Galcanezumab is effective in patients with episodic or chronic migraine after one to six months use. It reduced MHDs and had an effective response rate. Moreover, it is generally safe except for injection site adverse events, and SAE, especially with galcanezumab 240mg.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><doi>10.1186/s41983-024-00834-8</doi><tpages>15</tpages><orcidid>https://orcid.org/0000-0003-0904-9153</orcidid><oa>free_for_read</oa></addata></record>
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subjects Clinical trials
Galcanezumab
Headache
LY2951742
Medicine
Medicine & Public Health
Meta-analysis
Migraine
Monoclonal antibodies
Neurology
Neurosurgery
Psychiatry
Response rates
Review
Systematic review
title Safety and efficacy of galcanezumab in chronic and episodic migraine patients: a systematic review and meta-analysis of randomized controlled trials
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