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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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Dalbeth, N, Jones, G ORCID: 0000-0002-9814-0006, Terkeltaub, R, Khanna, D, Kopicko, J, Bhakta, N, Adler, S, Fung, M, Storgard, C, Baumgartner, S and Perez-Ruiz, F 2017 , 'Lesinurad, a selective uric acid reabsorption inhibitor, in combination with febuxostat in patients with tophaceous gout: Findings of a Phase III Clinical Trial' , Arthritis & Rheumatology, vol. 69, no. 9 , pp. 1903-1913 , doi: 10.1002/art.40159.

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Abstract

Objective: To investigate the efficacy and safety of lesinurad in combination with febuxostat in a 12-month phase III trial in patients with tophaceous gout.Methods: 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 Results: 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 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 Conclusion: 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.

Item Type: Article
Authors/Creators:Dalbeth, N and Jones, G and Terkeltaub, R and Khanna, D and Kopicko, J and Bhakta, N and Adler, S and Fung, M and Storgard, C and Baumgartner, S and Perez-Ruiz, F
Journal or Publication Title: Arthritis & Rheumatology
Publisher: John Wiley & Sons, Inc.
ISSN: 2326-5191
DOI / ID Number: 10.1002/art.40159
Copyright Information:

Copyright 2017 The Authors. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) http://creativecommons.org/licenses/by-nc-nd/4.0/

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