{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,25]],"date-time":"2026-10-25T05:19:51Z","timestamp":1792905591996,"version":"4.5.0"},"reference-count":34,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T00:00:00Z","timestamp":1757289600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Dotinurad is a selective urate reabsorption inhibitor that reduces serum urate levels. We compared the efficacy and safety of dotinurad with febuxostat in Chinese patients with gout.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This phase 3, multicenter, randomized, double\u2010blind, parallel\u2010group study randomly allocated (1:1) eligible patients with gout to receive oral dotinurad or febuxostat. The primary end point was the responder rate (proportion of patients achieving serum urate levels \u22646.0 mg\/dL) at week 24 in the full analysis set (FAS) to demonstrate superiority of dotinurad 4 mg\/day to febuxostat 40 mg\/day. The secondary end points included the responder rate at week 12 to show the noninferiority of dotinurad 2 mg\/day to febuxostat 40 mg\/day. Treatment\u2010emergent adverse events (TEAEs) were also recorded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 451 patients were randomized, and 441 were included in the FAS. Baseline characteristics were well balanced between treatment groups. The responder rate at week 24 was significantly higher for dotinurad 4 mg\/day versus febuxostat 40 mg\/day (73.6% vs 38.1%; adjusted difference 35.9% [95% confidence interval (CI) 27.4%\u201344.4%];\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.0001), and at week 12, dotinurad 2 mg\/day was noninferior to febuxostat 40 mg\/day (55.5% vs 50.5%; adjusted difference 5.2% [95% CI \u22123.7% to 14.2%]). Incidences of TEAEs in the dotinurad and febuxostat groups were similar.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Dotinurad 4 mg\/day was superior to febuxostat 40 mg\/day in achieving serum urate levels \u22646.0 mg\/dL at week 24 and was well tolerated in Chinese patients with gout.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.43261","type":"journal-article","created":{"date-parts":[[2025,5,26]],"date-time":"2025-05-26T06:54:52Z","timestamp":1748242492000},"page":"1757-1766","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Efficacy and Safety of Dotinurad Versus Febuxostat for the Treatment of Gout: A Randomized, Multicenter, Double\u2010Blind, Phase 3 Trial in China"],"prefix":"10.1002","volume":"77","author":[{"given":"Jia","family":"Sun","sequence":"first","affiliation":[{"name":"Department of Endocrinology Zhujiang Hospital of Southern Medical University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology Peking University First Hospital  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongjing","family":"Cheng","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Beijing Hospital National Centre of Gerontology  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongmei","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Foshan First People's Hospital  Foshan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiankang","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Jiangxi Pingxiang People's Hospital  Pingxiang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongzhou","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Shenzhen People's Hospital  Shenzhen Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhengnan","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)  Dalian China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4622-3731","authenticated-orcid":false,"given":"Changgui","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Metabolic Diseases The Affiliated Hospital of Qingdao University  Qingdao China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yibing","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Endocrinology The Second Affiliated Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaodan","family":"Kong","sequence":"additional","affiliation":[{"name":"Department of Rheumatology The Second Affiliated Hospital of Dalian Medical University  Dalian China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Immunology, Tong Ren Hospital Shanghai Jiaotong University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenyu","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Rheumatology The First Hospital of Jilin University  Changchun China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Yi","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Rheumatology The Third Xiangya Hospital of Central South University  Changsha China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongfeng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Immunology The First Affiliated Hospital of Dalian Medical University  Dalian China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baijie","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Jieyang People's Hospital  Jieyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shihao","family":"Yu","sequence":"additional","affiliation":[{"name":"Eisai China Inc.  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