%0 Systematic Review
%T Systematic review of gender bias in clinical trials of monoclonal antibodies for the treatment of multiple sclerosis.
%A Alonso-Moreno M
%A Ladrón-Guevara M
%A Ciudad-Gutiérrez P
%J Neurologia (Engl Ed)
%V 38
%N 9
%D 2023 Nov-Dec
%M 37996214
暂无%R 10.1016/j.nrleng.2021.01.008
%X <B>BACKGROUND: </B>This article analyses the presence of gender bias in clinical trials of monoclonal antibodies used to treat multiple sclerosis.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.