{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T20:11:13Z","timestamp":1790885473852,"version":"4.1.0"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T00:00:00Z","timestamp":1725494400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,25]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Urate-lowering efficacy and safety of febuxostat was evaluated in paediatric patients with hyperuricaemia including gout.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A Phase 2 study of febuxostat in paediatric patients aged 6\u201318\u2009years with hyperuricaemia including gout was conducted. We evaluated the proportion of patients achieving serum uric acid (sUA) level \u22646.0\u2009mg\/dl at Week 26, and long-term safety and efficacy at Week 52. We also considered efficacy stratified by renal function.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Thirty patients (10 at &amp;lt;40\u2009kg and 20 at \u226540\u2009kg) were enrolled. Twenty-four were males, 29 had asymptomatic hyperuricaemia, and 1 had gout. Age was 8 to 18\u2009years. Of these, 63.3% (95% confidence interval 43.9\u201380.1%) achieved a sUA level of \u22646.0\u2009mg\/dl at Week 26. sUA level (mean\u2009\u00b1\u2009standard deviation) was 5.55\u2009\u00b1\u20090.87\u2009mg\/dl, reduced from 9.01\u2009\u00b1\u20091.23\u2009mg\/dl at baseline. Febuxostat efficacy appeared similar for mild to moderate renal dysfunction and with normal renal function. There were no major safety issues.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In paediatric patients with hyperuricaemia including gout, febuxostat showed long-term, well-controlled urate-lowering efficacy with no major safety issues. Findings suggest that no dose adjustment is required for paediatric patients with mild to moderate renal dysfunction.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/mr\/roae056","type":"journal-article","created":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T18:55:52Z","timestamp":1725562552000},"page":"194-202","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and safety of febuxostat in Japanese paediatric patients with hyperuricaemia including gout: Phase 2, single arm, open\u2012label, multicentre studies"],"prefix":"10.1093","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5242-8987","authenticated-orcid":false,"given":"Shuichi","family":"Ito","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Graduate School of Medicine, Yokohama City University , Kanagawa,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yo","family":"Morita","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Teijin Pharma Limited , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Nitami","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Teijin Pharma Limited , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryutaro","family":"Iwama","sequence":"additional","affiliation":[{"name":"Toxicology & DMPK Research Department, Teijin Institute for Bio-medical Research, Teijin Pharma Limited , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiro","family":"Nakajima","sequence":"additional","affiliation":[{"name":"Clinical Development Control Department, Teijin Pharma Limited , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisashi","family":"Yamanaka","sequence":"additional","affiliation":[{"name":"Rheumatology, Sanno Medical Center , Tokyo,","place":["Japan"]},{"name":"Department of Rheumatology, International University of Health and Welfare , Chiba,","place":["Japan"]},{"name":"Institute of Rheumatology, Tokyo Women\u2019s Medical University , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masataka","family":"Honda","sequence":"additional","affiliation":[{"name":"Clinical Research Support Center, Tokyo Metropolitan Children\u2019s Medical Center , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,9,5]]},"reference":[{"key":"2025020515453573300_R1","doi-asserted-by":"crossref","first-page":"579","DOI":"10.1515\/jpem-2015-0290","article-title":"Urate crystals deposition in the feet of 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