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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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. |
doi_str_mv | 10.1186/s41983-024-00834-8 |
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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.</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 & 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. Moreover, it is generally safe except for injection site adverse events, and SAE, especially with galcanezumab 240mg.</description><subject>Clinical trials</subject><subject>Galcanezumab</subject><subject>Headache</subject><subject>LY2951742</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Meta-analysis</subject><subject>Migraine</subject><subject>Monoclonal antibodies</subject><subject>Neurology</subject><subject>Neurosurgery</subject><subject>Psychiatry</subject><subject>Response rates</subject><subject>Review</subject><subject>Systematic review</subject><issn>1687-8329</issn><issn>1110-1083</issn><issn>1687-8329</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNp9UcuKFTEQbUTBYZwfcBVw3ZpXd9LuZPAxMOBCXYfqpHLN0J1ck1yl5zv8YDO3RV25qqrDeVCcrnvO6EvG9PiqSDZp0VMue0q1kL1-1F2wUateCz49_md_2l2VEmYqOWNUTeyi-_kJPNaNQHQEvQ8W7EaSJwdYLES8P60wkxCJ_ZpTDHbnHUNJrh1rOGQIEckRasBYy2sCpGyl4toASzJ-D_jjrFmxQg8Rlq2E8hCQG5rWcI-O2BRrTsvS1poDLOVZ98S3gVe_52X35d3bz9cf-tuP72-u39z2Vmhae6COSqQo50FJqvSgnB0G4UAJqyUINfNZzIKNbFIeQTvvHDoccbBqpEyIy-5m93UJ7swxhxXyZhIEcwZSPhjI7ZEFzTh7p7hQyvpRclRAxSwdF1ROwnHtm9eL3euY07cTlmru0im3h4sRdJCCScWHxuI7y-ZUSkb_J5VR81Cm2cs0rUxzLtPoJhK7qDRyPGD-a_0f1S9S66S7</recordid><startdate>20240513</startdate><enddate>20240513</enddate><creator>Zaazouee, Mohamed Sayed</creator><creator>Ebrahim, Rokaya Y.</creator><creator>Al-araj, Ghaida’a</creator><creator>Zaki, Ibram</creator><creator>Saad, Ahmed</creator><creator>Farhat, Abdullah Mohamed</creator><creator>Ali, Mustafa Hussein</creator><creator>Elshennawy, Mohamed</creator><creator>Fawy, Omar Khaled Fahmy</creator><creator>Ahmed, Hadi F.</creator><creator>Alahmad, Ziad</creator><creator>Nada, Eman Ayman</creator><creator>Abo-Hamra, Reem I.</creator><creator>Elsnhory, Ahmed Bostamy</creator><creator>Eleyan, Mohammed</creator><creator>AbuEl-Enien, Hazem</creator><creator>Elromely, Rasha Abdo</creator><creator>AbdelQadir, Yossef Hassan</creator><creator>Shah, Jaffer</creator><creator>Elshanbary, Alaa Ahmed</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><general>SpringerOpen</general><scope>C6C</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>M0S</scope><scope>M2M</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0003-0904-9153</orcidid></search><sort><creationdate>20240513</creationdate><title>Safety and efficacy of galcanezumab in chronic and episodic migraine patients: a systematic review and meta-analysis of randomized controlled trials</title><author>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</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 & 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 & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>ProQuest Psychology</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>The Egyptian Journal of Neurology, Psychiatry and Neurosurgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zaazouee, Mohamed Sayed</au><au>Ebrahim, Rokaya Y.</au><au>Al-araj, Ghaida’a</au><au>Zaki, Ibram</au><au>Saad, Ahmed</au><au>Farhat, Abdullah Mohamed</au><au>Ali, Mustafa Hussein</au><au>Elshennawy, Mohamed</au><au>Fawy, Omar Khaled Fahmy</au><au>Ahmed, Hadi F.</au><au>Alahmad, Ziad</au><au>Nada, Eman Ayman</au><au>Abo-Hamra, Reem I.</au><au>Elsnhory, Ahmed Bostamy</au><au>Eleyan, Mohammed</au><au>AbuEl-Enien, Hazem</au><au>Elromely, Rasha Abdo</au><au>AbdelQadir, Yossef Hassan</au><au>Shah, Jaffer</au><au>Elshanbary, Alaa Ahmed</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of galcanezumab in chronic and episodic migraine patients: a systematic review and meta-analysis of randomized controlled trials</atitle><jtitle>The Egyptian Journal of Neurology, Psychiatry and Neurosurgery</jtitle><stitle>Egypt J Neurol Psychiatry Neurosurg</stitle><date>2024-05-13</date><risdate>2024</risdate><volume>60</volume><issue>1</issue><spage>60</spage><epage>15</epage><pages>60-15</pages><artnum>60</artnum><issn>1687-8329</issn><issn>1110-1083</issn><eissn>1687-8329</eissn><abstract>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.</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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