Abstract：
BACKGROUND: This article analyses the presence of gender bias in clinical trials of monoclonal antibodies used to treat multiple sclerosis.
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.
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.
摘要：
背景：本文分析了用于治疗多发性硬化症的单克隆抗体的临床试验中性别偏见的存在。
方法：我们对4种用于治疗多发性硬化症的单克隆抗体（那他珠单抗，利妥昔单抗,阿仑单抗，和奥克雷珠单抗)。我们在PubMed/MEDLINE数据库中搜索了2020年3月之前以英文发表的文章。这项研究是根据相关国际建议进行的。
结果：搜索确定了89篇文章，其中55项符合纳入标准。在这些试验中包括的所有患者中，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项包括对主要终点的基于性别的分析。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显著的性别偏见。在大多数情况下,主要和次要终点不根据患者性别进行分析，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推断更广泛人群的最低要求。
方法：我们对4种用于治疗多发性硬化症的单克隆抗体（那他珠单抗，利妥昔单抗,阿仑单抗，和奥克雷珠单抗)。我们在PubMed/MEDLINE数据库中搜索了2020年3月之前以英文发表的文章。这项研究是根据相关国际建议进行的。
结果：搜索确定了89篇文章，其中55项符合纳入标准。在这些试验中包括的所有患者中，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项包括对主要终点的基于性别的分析。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显著的性别偏见。在大多数情况下,主要和次要终点不根据患者性别进行分析，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推断更广泛人群的最低要求。
