Systematic review of gender bias in clinical trials of monoclonal antibodies for the treatment of multiple sclerosis

M. Alonso-Moreno, M. Ladrón-Guevara, P. Ciudad-Gutiérrez
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引用次数: 3

Abstract

Introduction

This article analyses the presence of gender bias in clinical trials of monoclonal antibodies used to treat multiple sclerosis.

Material and methods

We performed a systematic review of controlled clinical trials of 4 monoclonal antibodies used to treat multiple sclerosis (natalizumab, rituximab, alemtuzumab, and ocrelizumab). We searched the PubMed/MEDLINE database for articles published in English before March 2020. The study was conducted in accordance with the relevant international recommendations.

Results

The search identified 89 articles, 55 of which met the inclusion criteria. Of all patients included in these trials, 64.6% were women. The lead authors of 10 of the studies were women. Fifteen of the 55 studies included a sex-based analysis of the primary endpoint. Only 8 articles discussed the results separately for men and for women.

Conclusions

The clinical trials of these 4 monoclonal antibodies present a significant gender bias. In most cases, the primary and secondary endpoints are not analyzed according to patient sex, despite the fact that international recommendations include this as a minimum requirement for ensuring scientific validity and obtaining appropriate results for extrapolation to the wider population.

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单克隆抗体治疗多发性硬化症临床试验中性别偏倚的系统评价。
本文分析了用于治疗多发性硬化症的单克隆抗体临床试验中存在的性别偏见。材料和方法:我们对用于治疗多发性硬化症的4种单克隆抗体(natalizumab, rituximab, alemtuzumab和ocrelizumab)的对照临床试验进行了系统回顾。我们在PubMed/MEDLINE数据库中检索了2020年3月之前发表的英文文章。这项研究是按照有关的国际建议进行的。结果:检索到89篇文章,其中55篇符合纳入标准。在这些试验的所有患者中,64.6%是女性。其中10项研究的主要作者是女性。55项研究中有15项包括基于性别的主要终点分析。只有8篇文章分别讨论了男性和女性的结果。结论:这4种单克隆抗体的临床试验存在明显的性别偏倚。在大多数情况下,主要和次要终点没有根据患者的性别进行分析,尽管国际建议将其作为确保科学有效性和获得适当结果以外推到更广泛人群的最低要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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