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Gender bias in clinical trials of biological agents for migraine: A systematic review

Migraine is considered one of the most disabling diseases. Currently, there are few studies on clinical migraine treatment based on sex-related differences, despite the important role of sex in migraine. Our aim was to evaluate gender bias in published clinical trials on monoclonal antibodies (erenu...

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Detalles Bibliográficos
Autores principales: Alonso-Moreno, Marta, Rodríguez-de Francisco, Lupe, Ciudad-Gutiérrez, Pablo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10237417/
https://www.ncbi.nlm.nih.gov/pubmed/37267250
http://dx.doi.org/10.1371/journal.pone.0286453
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author Alonso-Moreno, Marta
Rodríguez-de Francisco, Lupe
Ciudad-Gutiérrez, Pablo
author_facet Alonso-Moreno, Marta
Rodríguez-de Francisco, Lupe
Ciudad-Gutiérrez, Pablo
author_sort Alonso-Moreno, Marta
collection PubMed
description Migraine is considered one of the most disabling diseases. Currently, there are few studies on clinical migraine treatment based on sex-related differences, despite the important role of sex in migraine. Our aim was to evaluate gender bias in published clinical trials on monoclonal antibodies (erenumab, galcanezumab, fremanezumab and eptinezumab). We performed a systematic review of controlled clinical trials of erenumab, galcanezumab, fremanezumab and eptinezumab, searching the PubMed/MEDLINE database for articles published before December 2021. The search identified 760 articles, 25 of which met the inclusion criteria. Of all the patients included in these trials, 85.1% were women. Only one study had female lead authors. Two of the 25 studies included a sex-based analysis of the primary endpoint. None of the articles discussed the results separately for men and for women. The proportion of men recruited in trials is scarce and more studies are needed to guarantee the safety and tolerability of monoclonal antibodies used in male migraine. As observed in our study, despite the high number of women recruited, only 2 studies analysed the results separately by sex. Thus, a potential risk of gender bias was found in these clinical trials.
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spelling pubmed-102374172023-06-03 Gender bias in clinical trials of biological agents for migraine: A systematic review Alonso-Moreno, Marta Rodríguez-de Francisco, Lupe Ciudad-Gutiérrez, Pablo PLoS One Research Article Migraine is considered one of the most disabling diseases. Currently, there are few studies on clinical migraine treatment based on sex-related differences, despite the important role of sex in migraine. Our aim was to evaluate gender bias in published clinical trials on monoclonal antibodies (erenumab, galcanezumab, fremanezumab and eptinezumab). We performed a systematic review of controlled clinical trials of erenumab, galcanezumab, fremanezumab and eptinezumab, searching the PubMed/MEDLINE database for articles published before December 2021. The search identified 760 articles, 25 of which met the inclusion criteria. Of all the patients included in these trials, 85.1% were women. Only one study had female lead authors. Two of the 25 studies included a sex-based analysis of the primary endpoint. None of the articles discussed the results separately for men and for women. The proportion of men recruited in trials is scarce and more studies are needed to guarantee the safety and tolerability of monoclonal antibodies used in male migraine. As observed in our study, despite the high number of women recruited, only 2 studies analysed the results separately by sex. Thus, a potential risk of gender bias was found in these clinical trials. Public Library of Science 2023-06-02 /pmc/articles/PMC10237417/ /pubmed/37267250 http://dx.doi.org/10.1371/journal.pone.0286453 Text en © 2023 Alonso-Moreno et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Alonso-Moreno, Marta
Rodríguez-de Francisco, Lupe
Ciudad-Gutiérrez, Pablo
Gender bias in clinical trials of biological agents for migraine: A systematic review
title Gender bias in clinical trials of biological agents for migraine: A systematic review
title_full Gender bias in clinical trials of biological agents for migraine: A systematic review
title_fullStr Gender bias in clinical trials of biological agents for migraine: A systematic review
title_full_unstemmed Gender bias in clinical trials of biological agents for migraine: A systematic review
title_short Gender bias in clinical trials of biological agents for migraine: A systematic review
title_sort gender bias in clinical trials of biological agents for migraine: a systematic review
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10237417/
https://www.ncbi.nlm.nih.gov/pubmed/37267250
http://dx.doi.org/10.1371/journal.pone.0286453
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