{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T08:27:30Z","timestamp":1777624050787,"version":"3.51.4"},"reference-count":34,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T00:00:00Z","timestamp":1697587200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Presenting the racial\/ethnic representation in clinical trials leading to new approvals of inflammatory arthritis (IA) by the US Food and Drug Administration (FDA) to determine the extent of racial\/ethnic disparities.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Pivotal trials supporting the approval of new indications from July 2012 to June 2022 were collected from Drugs@FDA, the FDA\u2010approved drugs database. More details were then identified by searching Pubmed and the National Institutes of Health trials registry. General characteristics of the approved drugs and demographic data for each pivotal trial, especially the race\/ethnicity data, were collected. The enrollment profiles of each race\/ethnicity were analyzed and then compared with the 2020 US census data.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>From 2012 to 2022, 34 new approvals were identified based on 59 clinical trials. The Black was consistently underrepresented in all subtypes of IA and drugs, while the White was overrepresented compared to the 2020 US census data.<\/jats:p><jats:p>For Asian and Hispanic participants, these pivotal trials presented relatively heterogeneities in enrollments. As for the trends over time, increased involvements of White were still observed in rheumatoid arthritis (RA), psoriatic arthritis, and spondyloarthritis, while increased involvements of Black and decreased enrollments of Asian and Hispanic were only observed in RA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Despite many efforts to eliminate racial\/ethnic disparities, the Black was consistently underrepresented in pivotal clinical trials compared to the 2020 US national race\/ethnicity distribution data. The White was consistently overrepresented, and the Hispanic presented heterogeneous results. No evident time trend was observed.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.14944","type":"journal-article","created":{"date-parts":[[2023,10,19]],"date-time":"2023-10-19T05:26:11Z","timestamp":1697693171000},"page":"2489-2497","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Characteristics of race\/ethnicity in trials leading to anti\u2010rheumatic drug approval for inflammatory arthritis by the <scp>US<\/scp> Food and Drug Administration"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8987-4844","authenticated-orcid":false,"given":"Yan","family":"Xie","sequence":"first","affiliation":[{"name":"Department of Rheumatology and Immunology West China Hospital Sichuan University  Chengdu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Liu","sequence":"additional","affiliation":[{"name":"Tsinghua Clinical Research Institute (TCRI) School of Medicine Tsinghua University  Beijing China"},{"name":"Clinical Trial Institute Beijing Tsinghua Changgung Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunhe","family":"Qin","sequence":"additional","affiliation":[{"name":"Pharmcube (Beijing) Co., Ltd.  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoyuan","family":"Chen","sequence":"additional","affiliation":[{"name":"Tsinghua Clinical Research Institute (TCRI) School of Medicine Tsinghua University  Beijing China"},{"name":"Clinical Trial Institute Beijing Tsinghua Changgung Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qibing","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Immunology West China Hospital Sichuan University  Chengdu China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,10,18]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-020-2115-4"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0000000000000782"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40744-021-00370-4"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.121147"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2020.07.008"},{"issue":"8","key":"e_1_2_12_7_1","first-page":"666","article-title":"Unequal treatment: confronting racial and ethnic disparities in health care","volume":"94","author":"Nelson A","year":"2002","journal-title":"J Natl Med Assoc"},{"issue":"12","key":"e_1_2_12_8_1","first-page":"2400","article-title":"Initiation of disease\u2010modifying antirheumatic drug therapy in minority and disadvantaged patients with rheumatoid arthritis","volume":"34","author":"Suarez\u2010Almazor ME","year":"2007","journal-title":"J Rheumatol"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2021.08.038"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2019.14745"},{"key":"e_1_2_12_11_1","unstructured":"BureauUC.The chance that two people chosen at random are of different race or ethnicity groups has increased since 2010. 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