Gao Angel, Pardo Pardo Jordi, Dang Steven, Gensler Lianne S, Mease Philip, Eder Lihi
Queen's University, Kingston, Ontario, Canada.
University of Ottawa, Ottawa, Ontario, Canada.
Arthritis Care Res (Hoboken). 2025 Jul;77(7):813-826. doi: 10.1002/acr.25512. Epub 2025 Mar 19.
We aimed to assess differences in baseline characteristics, efficacy, and safety of advanced therapies between male and female patients with axial spondyloarthritis (axSpA) in randomized controlled trials (RCTs).
We conducted a systematic literature search for RCTs assessing the efficacy of advanced therapies in patients with axSpA until March 19, 2023. We extracted the following outcomes by sex: baseline participant characteristics, Assessment in Spondylarthritis International Society (ASAS) 20/40 criteria, and Axial Spondyloarthritis Disease Activity Score low disease activity or inactive disease (ASDAS-LDA/ID). Random-effects models were used to calculate pooled effects for responses in men versus women for different medication classes.
We included 79 RCTs (n = 23,748 patients, 69.7% male). Only 9 trials (11.4%), 22 trials (28%), and 9 trials (11.4%) reported baseline characteristics, efficacy end points, and safety end points by sex, respectively. At baseline, women were significantly older and had higher pain scores, whereas men had higher C-reactive protein levels. Overall, male patients were more likely to achieve an ASAS40 response compared to female patients for all advanced therapies (odds ratio [OR] 1.88, 95% confidence interval [CI] 1.44-2.46) and for interleukin-17A (IL-17A) inhibitors (IL-17Ai) (OR 1.82) and tumor necrosis factor inhibitor (TNFi) (OR 2.42), and male patients had numerically higher values for IL-17A/Fi. Male patients were also more likely to achieve an ASDAS-LDA/ID (OR 2.19, 95% CI 1.47-3.26) across all advanced therapies and for IL-17Ai (OR 2.08) and TNFi (OR 2.42) individually.
Female patients with axSpA are less likely to achieve efficacy outcomes on advanced therapies compared to their male counterparts, with similar differences across medication classes. Future studies should study the biologic (sex-related) and sociocultural (gender-related) mechanisms underlying these differences.
我们旨在评估在随机对照试验（RCT）中，轴性脊柱关节炎（axSpA）男性和女性患者在接受先进疗法时的基线特征、疗效和安全性差异。
我们对截至2023年3月19日评估先进疗法对axSpA患者疗效的RCT进行了系统的文献检索。我们按性别提取了以下结果：参与者基线特征、国际脊柱关节炎协会（ASAS）20/40标准，以及轴性脊柱关节炎疾病活动评分低疾病活动度或非活动疾病（ASDAS-LDA/ID）。随机效应模型用于计算不同药物类别中男性与女性反应的合并效应。
我们纳入了79项RCT（n = 23,748例患者，69.7%为男性）。分别只有9项试验（11.4%）、22项试验（28%）和9项试验（11.4%）报告了按性别划分的基线特征、疗效终点和安全性终点。在基线时，女性年龄显著更大且疼痛评分更高，而男性C反应蛋白水平更高。总体而言，对于所有先进疗法，男性患者比女性患者更有可能实现ASAS40反应（优势比[OR] 1.88，95%置信区间[CI] 1.44 - 2.46），对于白细胞介素-17A（IL-17A）抑制剂（IL-17Ai）（OR 1.82）和肿瘤坏死因子抑制剂（TNFi）（OR 2.42）也是如此，并且男性患者的IL-17A/Fi数值更高。在所有先进疗法以及单独使用IL-17Ai（OR 2.08）和TNFi（OR 2.42）时，男性患者也更有可能实现ASDAS-LDA/ID（OR 2.19，95% CI 1.47 - 3.26）。
与男性患者相比，axSpA女性患者接受先进疗法时不太可能获得疗效结果，不同药物类别之间存在类似差异。未来的研究应探究这些差异背后的生物学（与性别相关）和社会文化（与性别相关）机制。
