Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: Findings of a Phase III Clinical Trial.

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dc.contributor.author Dalbeth, Nicola en
dc.contributor.author Jones, Graeme en
dc.contributor.author Terkeltaub, Robert en
dc.contributor.author Khanna, Dinesh en
dc.contributor.author Kopicko, Jeff en
dc.contributor.author Bhakta, Nihar en
dc.contributor.author Adler, Scott en
dc.contributor.author Fung, Maple en
dc.contributor.author Storgard, Chris en
dc.contributor.author Baumgartner, Scott en
dc.contributor.author Perez-Ruiz, Fernando en
dc.date.accessioned 2018-11-05T00:37:02Z en
dc.date.issued 2017-09 en
dc.identifier.citation Arthritis & Rheumatology 69(9):1903-1913 Sep 2017 en
dc.identifier.issn 2326-5191 en
dc.identifier.uri http://hdl.handle.net/2292/43867 en
dc.description.abstract To investigate the efficacy and safety of lesinurad in combination with febuxostat in a 12-month phase III trial in patients with tophaceous gout.Patients with serum urate (UA) ≥8.0 mg/dl (≥6.0 mg/dl with urate-lowering therapy) and ≥1 measurable target tophus were given febuxostat 80 mg/day for 3 weeks before randomization to receive lesinurad (200 or 400 mg daily) or placebo in addition to the febuxostat. The primary end point was the proportion of patients achieving a serum UA level of <5.0 mg/dl (month 6). The key secondary end point was the proportion of patients with complete resolution of ≥1 target tophus (month 12). Other end points included the percentage change in total target tophi area. Safety assessments included adverse events and laboratory data.Patients (n = 324) were predominantly male, with a mean age of 54.1 years. Significantly more patients achieved the serum UA target by month 6 with the addition of lesinurad 400 mg (76.1%; P < 0.0001), but not 200 mg (56.6%; P = 0.13), to the febuxostat therapy as compared with febuxostat alone (46.8%). At all other time points, significantly more patients in the lesinurad 200 mg group achieved the serum UA target. The number of patients with complete tophus resolution was not different between groups. Treatment with lesinurad (200 mg and 400 mg) plus febuxostat reduced the total target tophi area as compared with febuxostat alone (50.1% and 52.9% versus 28.3%, respectively; P < 0.05). Safety was generally comparable with that of febuxostat alone, except for higher rates of predominantly reversible elevations in the serum creatinine level, particularly with lesinurad 400 mg.Treatment with lesinurad in combination with febuxostat demonstrated superior lowering of serum UA levels as compared with febuxostat alone, with clinically relevant added effects on tophi and an acceptable safety profile with lesinurad 200 mg in patients with tophaceous gout warranting additional therapy. en
dc.format.medium Print-Electronic en
dc.language eng en
dc.relation.ispartofseries Arthritis & rheumatology (Hoboken, N.J.) en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/ en
dc.subject Humans en
dc.subject Gout en
dc.subject Thioglycolates en
dc.subject Triazoles en
dc.subject Creatinine en
dc.subject Uric Acid en
dc.subject Gout Suppressants en
dc.subject Treatment Outcome en
dc.subject Drug Therapy, Combination en
dc.subject Double-Blind Method en
dc.subject Middle Aged en
dc.subject Female en
dc.subject Male en
dc.subject Febuxostat en
dc.title Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: Findings of a Phase III Clinical Trial. en
dc.type Journal Article en
dc.identifier.doi 10.1002/art.40159 en
pubs.issue 9 en
pubs.begin-page 1903 en
pubs.volume 69 en
dc.rights.holder Copyright: The authors en
dc.identifier.pmid 28597604 en
pubs.end-page 1913 en
pubs.publication-status Published en
dc.rights.accessrights http://purl.org/eprint/accessRights/OpenAccess en
pubs.subtype Clinical Trial, Phase III en
pubs.subtype Research Support, Non-U.S. Gov't en
pubs.subtype research-article en
pubs.subtype Multicenter Study en
pubs.subtype Randomized Controlled Trial en
pubs.subtype Journal Article en
pubs.elements-id 632424 en
pubs.org-id Medical and Health Sciences en
pubs.org-id School of Medicine en
pubs.org-id Medicine Department en
dc.identifier.eissn 2326-5205 en
pubs.record-created-at-source-date 2017-06-10 en
pubs.dimensions-id 28597604 en

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