Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, US Food and Drug Administration, Silver Spring, Maryland, USA.
Division of Clinical Pharmacology II, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
J Clin Pharmacol. 2020 Dec;60 Suppl 2:S103-S109. doi: 10.1002/jcph.1776.
The prevalence of rheumatoid arthritis (RA) is higher in females than in males. With the development of new treatment options and strategies such as biologics, we found it worthwhile to identify whether males and females warrant different treatment regimens to ensure the best clinical response. Our meta-analysis included 11 clinical trials of RA patients in support of the Food and Drug Administration's approval of 6 biological products. We evaluated the data of American College of Rheumatology 20 (ACR20) 24 or 26 weeks after treatment. Logistic regression models were applied to compute the odds ratio (OR) of treatment responses between sexes. The ORs of ACR20 response rates in males and females were similar across all studies and not significantly different in overall studies (OR, 1.05; 95% confidence interval, 0.96-1.16) analyzed with a fixed-effects model. Further analyses on the 7 ACR20 subcomponents showed high heterogeneity among studies (Q statistic P < .00007, I > 95%), with no observed clinically meaningful sex-related difference. Thus, our meta-analysis did not find significant difference in ACR20 response rates between male and female RA patients treated with biologics at approved dosing regimens. This result supports the current clinical practice of not requiring sex-dependent treatment regimens for RA patients.
类风湿关节炎（RA）在女性中的患病率高于男性。随着新的治疗选择和策略（如生物制剂）的发展，我们发现有必要确定男性和女性是否需要不同的治疗方案，以确保获得最佳的临床反应。我们的荟萃分析包括支持食品和药物管理局批准 6 种生物制品的 11 项 RA 患者临床试验。我们评估了治疗后 24 或 26 周美国风湿病学会 20 项（ACR20）的数据。应用逻辑回归模型计算性别间治疗反应的优势比（OR）。固定效应模型分析显示，所有研究中男性和女性的 ACR20 反应率 OR 相似，总体研究中无显著差异（OR，1.05；95%置信区间，0.96-1.16）。进一步对 7 个 ACR20 亚组分的分析显示，研究之间存在高度异质性（Q 统计量 P <.00007，I > 95%），未观察到有临床意义的性别相关差异。因此，我们的荟萃分析并未发现生物制剂批准剂量方案治疗的男性和女性 RA 患者的 ACR20 反应率存在显著差异。这一结果支持当前不要求 RA 患者根据性别制定治疗方案的临床实践。
