Pharmacy Unit, Virgen del Rocío University Hospital, Seville, Spain.
PLoS One. 2023 Jun 2;18(6):e0286453. doi: 10.1371/journal.pone.0286453. eCollection 2023.
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.
偏头痛被认为是最具致残性的疾病之一。尽管性别在偏头痛中起着重要作用，但目前基于性别差异的偏头痛临床治疗研究较少。我们旨在评估已发表的单克隆抗体（erenumab、galcanezumab、fremanezumab 和 eptinezumab）治疗偏头痛的临床研究中是否存在性别偏见。我们对 erenumab、galcanezumab、fremanezumab 和 eptinezumab 的对照临床试验进行了系统评价，在 PubMed/MEDLINE 数据库中搜索了截至 2021 年 12 月之前发表的文章。该搜索共确定了 760 篇文章，其中 25 篇符合纳入标准。在这些试验中纳入的所有患者中，85.1%为女性。仅有一项研究的主要作者为女性。25 项研究中有两项对主要终点进行了基于性别的分析。没有一篇文章分别讨论男性和女性的结果。试验中招募的男性人数很少，需要更多的研究来保证用于男性偏头痛的单克隆抗体的安全性和耐受性。正如我们的研究观察到的那样，尽管纳入了大量女性，但只有 2 项研究分别按性别分析了结果。因此，在这些临床试验中发现了潜在的性别偏见风险。
