Choufani Mathieu, Ghusn Wissam, Dubreuil Maureen, Ermann Joerg
M. Choufani, MD, Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, Massachusetts, USA.
W. Ghusn, MD, Department of Internal Medicine, Boston Medical Center, Boston, Massachusetts, USA.
J Rheumatol. 2025 Mar 15. doi: 10.3899/jrheum.2024-1013.
To examine demographic and geographic diversity in axial spondyloarthritis (axSpA) drug trials.
We performed a descriptive epidemiological study using ClinicalTrials.gov data. We included completed phase II-IV drug trials in adults with axSpA, conducted between 2000 and 2023, with results posted on ClinicalTrials.gov. We extracted and analyzed data on sex, race, ethnicity, trial characteristics and trial locations.
59 trials with 16,162 participants were analyzed. Females constituted 30% of participants overall: 25% in AS/r-axSpA trials, 34% in axSpA trials, and 48% in nr-axSpA trials. 31 trials (53%) reported race, and 12 (20%) reported both race and ethnicity. Race reporting increased from 9% of trials (2000-2010) to 53% (2011-2015) and 100% (2016-2020). Among 10,037 participants with race data, 82% were White, 15% Asian, 2% American Indian/Alaska Native, 1% Black, and 0.02% Native Hawaiian/Pacific Islander. Asian representation increased from 4% (2011-2015) to 19% (2016-2020), American Indian/Alaska Native from 1% to 3%, while Black representation remained consistently low at 1%. Among 3,577 patients with ethnicity data, 14% of participants were Hispanic/Latino, increasing from 1% (2011-2015) to 14% (2016-2020). 51 trials with location data enrolled participants from 53 countries. Sub-Saharan Africa (0%) and South/Central Asia (2%) had the lowest geographic representation of enrollment sites.
The enrollment of women in axSpA drug trials largely reflects disease demographics. Race and ethnicity reporting has improved over time. While participation of Asian, American Indian/Alaska Native and Hispanic/Latino patients has increased, Black and Native Hawaiian/Pacific Islander representation has remained low. Future efforts should prioritize inclusivity and participation in underrepresented regions globally.
研究轴性脊柱关节炎（axSpA）药物试验中的人口统计学和地理多样性。
我们使用ClinicalTrials.gov数据进行了一项描述性流行病学研究。我们纳入了2000年至2023年间在成年axSpA患者中完成的II-IV期药物试验，试验结果已发布在ClinicalTrials.gov上。我们提取并分析了关于性别、种族、民族、试验特征和试验地点的数据。
分析了59项试验，共16162名参与者。女性占总体参与者的30%：在强直性脊柱炎/放射学阴性中轴性脊柱关节炎（AS/r-axSpA）试验中占25%，在axSpA试验中占34%，在非放射学中轴性脊柱关节炎（nr-axSpA）试验中占48%。31项试验（53%）报告了种族，12项试验（20%）报告了种族和民族。报告种族的试验比例从2000 - 2010年的9%增至2011 - 2015年的53%以及2016 - 2020年的100%。在有种族数据的10037名参与者中，82%为白人，15%为亚洲人，2%为美洲印第安人/阿拉斯加原住民，1%为黑人，0.02%为夏威夷原住民/太平洋岛民。亚洲人的占比从2011 - 2015年的4%增至2016 - 2020年的19%，美洲印第安人/阿拉斯加原住民从1%增至3%，而黑人的占比一直较低，为1%。在有民族数据的3577名患者中，14%的参与者为西班牙裔/拉丁裔，从2011 - 2015年的1%增至2016 - 2020年的14%。51项有地点数据的试验招募了来自53个国家的参与者。撒哈拉以南非洲（0%）和南亚/中亚（2%）的试验招募地点在地理上的代表性最低。
axSpA药物试验中女性的纳入情况在很大程度上反映了疾病的人口统计学特征。随着时间推移，种族和民族报告情况有所改善。虽然亚洲、美洲印第安人/阿拉斯加原住民以及西班牙裔/拉丁裔患者的参与度有所增加，但黑人及夏威夷原住民/太平洋岛民的代表性仍然较低。未来的工作应优先考虑全球范围内代表性不足地区的包容性和参与度。
