Efficacy and safety of febuxostat in Japanese paediatric patients with hyperuricaemia including gout: Phase 2, single arm, open‒label, multicentre studies

Urate-lowering efficacy and safety of febuxostat was evaluated in paediatric patients with hyperuricaemia including gout. A Phase 2 study of febuxostat in paediatric patients aged 6-18 years with hyperuricaemia including gout was conducted. We evaluated the proportion of patients achieving serum uri...

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Veröffentlicht in:	Modern rheumatology 2024-12, Vol.35 (1), p.194-202
Hauptverfasser:	Ito, Shuichi, Morita, Yo, Nitami, Makoto, Iwama, Ryutaro, Nakajima, Akihiro, Yamanaka, Hisashi, Honda, Masataka
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Child East Asian People Febuxostat - adverse effects Febuxostat - therapeutic use Female Gout - blood Gout - drug therapy Gout Suppressants - adverse effects Gout Suppressants - therapeutic use Humans Hyperuricemia - blood Hyperuricemia - drug therapy Japan Male Treatment Outcome Uric Acid - blood
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container_title	Modern rheumatology
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creator	Ito, Shuichi Morita, Yo Nitami, Makoto Iwama, Ryutaro Nakajima, Akihiro Yamanaka, Hisashi Honda, Masataka
description	Urate-lowering efficacy and safety of febuxostat was evaluated in paediatric patients with hyperuricaemia including gout. A Phase 2 study of febuxostat in paediatric patients aged 6-18 years with hyperuricaemia including gout was conducted. We evaluated the proportion of patients achieving serum uric acid (sUA) level ≤6.0 mg/dl at Week 26, and long-term safety and efficacy at Week 52. We also considered efficacy stratified by renal function. Thirty patients (10 at
doi_str_mv	10.1093/mr/roae056
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A Phase 2 study of febuxostat in paediatric patients aged 6-18 years with hyperuricaemia including gout was conducted. We evaluated the proportion of patients achieving serum uric acid (sUA) level ≤6.0 mg/dl at Week 26, and long-term safety and efficacy at Week 52. We also considered efficacy stratified by renal function. Thirty patients (10 at <40 kg and 20 at ≥40 kg) were enrolled. Twenty-four were males, 29 had asymptomatic hyperuricaemia, and 1 had gout. Age was 8 to 18 years. Of these, 63.3% (95% confidence interval 43.9-80.1%) achieved a sUA level of ≤6.0 mg/dl at Week 26. sUA level (mean ± standard deviation) was 5.55 ± 0.87 mg/dl, reduced from 9.01 ± 1.23 mg/dl at baseline. Febuxostat efficacy appeared similar for mild to moderate renal dysfunction and with normal renal function. There were no major safety issues. In paediatric patients with hyperuricaemia including gout, febuxostat showed long-term, well-controlled urate-lowering efficacy with no major safety issues. 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A Phase 2 study of febuxostat in paediatric patients aged 6-18 years with hyperuricaemia including gout was conducted. We evaluated the proportion of patients achieving serum uric acid (sUA) level ≤6.0 mg/dl at Week 26, and long-term safety and efficacy at Week 52. We also considered efficacy stratified by renal function. Thirty patients (10 at <40 kg and 20 at ≥40 kg) were enrolled. Twenty-four were males, 29 had asymptomatic hyperuricaemia, and 1 had gout. Age was 8 to 18 years. Of these, 63.3% (95% confidence interval 43.9-80.1%) achieved a sUA level of ≤6.0 mg/dl at Week 26. sUA level (mean ± standard deviation) was 5.55 ± 0.87 mg/dl, reduced from 9.01 ± 1.23 mg/dl at baseline. Febuxostat efficacy appeared similar for mild to moderate renal dysfunction and with normal renal function. There were no major safety issues. 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.</description><subject>Adolescent</subject><subject>Child</subject><subject>East Asian People</subject><subject>Febuxostat - adverse effects</subject><subject>Febuxostat - therapeutic use</subject><subject>Female</subject><subject>Gout - blood</subject><subject>Gout - drug therapy</subject><subject>Gout Suppressants - adverse effects</subject><subject>Gout Suppressants - therapeutic use</subject><subject>Humans</subject><subject>Hyperuricemia - blood</subject><subject>Hyperuricemia - drug therapy</subject><subject>Japan</subject><subject>Male</subject><subject>Treatment Outcome</subject><subject>Uric Acid - blood</subject><issn>1439-7595</issn><issn>1439-7609</issn><issn>1439-7609</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kU1OwzAQhS0EoqWw4QDIS4Raasc4idkhxK8qwYJ9NHHG1Ch_2I6gO87AmtNxEoxoWc3T0_eeNDOEHHJ2ypkS88bNXQfIZLpFxvxMqFmWMrW90VLJEdnz_oUxIVWudslIqERILrIx-boyxmrQKwptRT0YDCvaGWqwHN47HyBQ29J76KFFj7QHrCwEZ3WUwWIbPH2zYUmXqx7dEH3AxkLM6HqobPtMn7shnNPHJcR0MqU-ejVScM2Udj223x-fNZRYT2kz1MHq2OiQ-hDD6PfJjoHa48F6TsjT9dXT5e1s8XBzd3mxmGmepWEGCWghRKrSrNRJbsoskZkRSuVnUKks11qyrNKiZLI0rFImKbmWWLE0lbniYkKO_2p7170O6EPRWK-xruPO3eALwRlTPJcyjejJH6pd571DU_TONuBWBWfF7zOKxhXrZ0T4aN07lA1W_-jm-uIHgtyKLg</recordid><startdate>20241225</startdate><enddate>20241225</enddate><creator>Ito, Shuichi</creator><creator>Morita, Yo</creator><creator>Nitami, Makoto</creator><creator>Iwama, Ryutaro</creator><creator>Nakajima, Akihiro</creator><creator>Yamanaka, Hisashi</creator><creator>Honda, Masataka</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-5242-8987</orcidid></search><sort><creationdate>20241225</creationdate><title>Efficacy and safety of febuxostat in Japanese paediatric patients with hyperuricaemia including gout: Phase 2, single arm, open‒label, multicentre studies</title><author>Ito, Shuichi ; Morita, Yo ; Nitami, Makoto ; Iwama, Ryutaro ; Nakajima, Akihiro ; Yamanaka, Hisashi ; Honda, Masataka</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c176t-a2ac3336967bc28fb7257f39984ad978cc507dc3b05bf0d9f2b1c5ed06658913</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adolescent</topic><topic>Child</topic><topic>East Asian People</topic><topic>Febuxostat - adverse effects</topic><topic>Febuxostat - therapeutic use</topic><topic>Female</topic><topic>Gout - blood</topic><topic>Gout - drug therapy</topic><topic>Gout Suppressants - adverse effects</topic><topic>Gout Suppressants - therapeutic use</topic><topic>Humans</topic><topic>Hyperuricemia - blood</topic><topic>Hyperuricemia - drug therapy</topic><topic>Japan</topic><topic>Male</topic><topic>Treatment Outcome</topic><topic>Uric Acid - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ito, Shuichi</creatorcontrib><creatorcontrib>Morita, Yo</creatorcontrib><creatorcontrib>Nitami, Makoto</creatorcontrib><creatorcontrib>Iwama, Ryutaro</creatorcontrib><creatorcontrib>Nakajima, Akihiro</creatorcontrib><creatorcontrib>Yamanaka, Hisashi</creatorcontrib><creatorcontrib>Honda, Masataka</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Modern rheumatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ito, Shuichi</au><au>Morita, Yo</au><au>Nitami, Makoto</au><au>Iwama, Ryutaro</au><au>Nakajima, Akihiro</au><au>Yamanaka, Hisashi</au><au>Honda, Masataka</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of febuxostat in Japanese paediatric patients with hyperuricaemia including gout: Phase 2, single arm, open‒label, multicentre studies</atitle><jtitle>Modern rheumatology</jtitle><addtitle>Mod Rheumatol</addtitle><date>2024-12-25</date><risdate>2024</risdate><volume>35</volume><issue>1</issue><spage>194</spage><epage>202</epage><pages>194-202</pages><issn>1439-7595</issn><issn>1439-7609</issn><eissn>1439-7609</eissn><abstract>Urate-lowering efficacy and safety of febuxostat was evaluated in paediatric patients with hyperuricaemia including gout. 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source	MEDLINE; Oxford University Press Journals All Titles (1996-Current)
subjects	Adolescent Child East Asian People Febuxostat - adverse effects Febuxostat - therapeutic use Female Gout - blood Gout - drug therapy Gout Suppressants - adverse effects Gout Suppressants - therapeutic use Humans Hyperuricemia - blood Hyperuricemia - drug therapy Japan Male Treatment Outcome Uric Acid - blood
title	Efficacy and safety of febuxostat in Japanese paediatric patients with hyperuricaemia including gout: Phase 2, single arm, open‒label, multicentre studies
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