Supplementary Material for: Racial, Ethnic, and Sex Disparities in Nail Psoriasis Clinical Trials: A Systematic Review

Introduction: Nail psoriasis (NP) disproportionally affects quality of life in females versus males. Demographics of NP research cohorts are not well characterized. In this systematic review, we characterize the representation of racial/ethnic groups and women in NP randomized clinical trials (RCTs). Methods: A systematic search of MEDLINE was performed; RCTs of NP pharmacologic treatments or cutaneous psoriasis/psoriatic arthritis with the number of NP patients described were included. Results: Overall, 45 RCTs were analyzed, with 91.1% reporting sex, and 67.9% of participants were men. 7/41 (17%) studies reporting sex included ≥45% female participants. Of 45 RCTs, 35.6% reported race and/or ethnicity. Of the 22 studies with ≥1 US-based site, 13 (59%) reported race/ethnicity; 3 out of 23 (13%) studies with <1 US-based site reported these data. Enrollment of nonwhite participants was significantly lower than representation within the US census (13.4% vs. 39.9%; p < 0.001). Treatment type, route of administration, location with ≥1 US-based site, funding, and journal type were significantly associated with race/ethnicity reporting (p < 0.05 all comparisons). Discussion/Conclusion: Reporting of racial/ethnic demographics is lacking in NP RCTs. Women and racial/ethnic minorities remain underrepresented in NP research. There is a need for increased reporting and diversification of NP clinical trial participants.

引言：指甲银屑病（Nail psoriasis, NP）对女性生活质量的不成比例影响显著高于男性。目前指甲银屑病研究队列的人口统计学特征尚未得到充分表征。本系统综述旨在刻画指甲银屑病随机对照试验（randomized clinical trials, RCTs）中种族/族裔群体与女性的入组代表性情况。
方法：本研究对MEDLINE数据库进行系统性检索；纳入两类随机对照试验：其一为针对指甲银屑病的药物治疗随机对照试验；其二为涉及皮肤银屑病或银屑病关节炎且明确报道了指甲银屑病患者数量的研究。
结果：最终共分析45项随机对照试验，其中91.1%的研究报道了受试者性别信息，受试人群中男性占比67.9%。在41项报道了性别数据的研究中，仅7项（17%）的女性受试者占比≥45%。45项研究中，仅35.6%报道了种族/族裔相关信息。在22家设有至少1个美国本土研究站点的研究中，有13项（59%）报道了种族/族裔数据；而23家未设有美国本土研究站点的研究中，仅3项（13%）报道了此类数据。非白人受试者的入组比例显著低于美国人口普查中的人口占比（13.4% vs. 39.9%；p < 0.001）。治疗类型、给药途径、是否设有美国本土研究站点、资助来源及期刊类型均与种族/族裔数据的报道情况存在显著关联（所有比较均p < 0.05）。
讨论与结论：指甲银屑病随机对照试验中种族/族裔人口统计学特征的报道存在显著缺失。女性与种族/族裔少数群体在指甲银屑病研究中的入组比例仍偏低。未来需加强相关数据的报道，并推动指甲银屑病临床试验受试者群体的多样化。