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Abstract Number: 209

Clinical Response of Tophus and Flares to Extended Use of Lesinurad in Combination with a Xanthine Oxidase Inhibitor in Patients with Gout

Thomas Bardin1, Nicola Dalbeth2, Robert Terkeltaub3, Chris Storgard4, Maple Fung4, Jia Hu4 and Fernando Perez-Ruiz5, 1Hôpital Lariboisière, Paris, France, 2University of Auckland, Auckland, New Zealand, 3Medicine-Rheumatology, VA Medical Ctr/University of California San Diego, San Diego, CA, 4Ardea Biosciences, Inc., San Diego, CA, 5Hospital de Cruces and Biocruces Health Research Institute, Vizcaya, Spain

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Allopurinol, Febuxostat, gout, hyperuricemia and tophaceous gout

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Session Information

Date: Sunday, November 13, 2016

Session Title: Metabolic and Crystal Arthropathies - Poster I: Clinical Practice

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Three randomized, double-blind, Phase III trials reported that greater proportions of patients treated with lesinurad 200 mg (LESU200) or 400 mg (LESU400), combined with the xanthine oxidase inhibitor (XOI) allopurinol (ALLO; CLEAR 1 and 2) or febuxostat (FBX; CRYSTAL), achieved serum uric acid (sUA) targets at 6 months versus xanthine oxidase inhibitor (XOI) alone. This analysis evaluated the impact of long-term treatment with lesinurad + XOI on tophus and flares for at least 1 year and up to 2 years.

Methods: Patients completing 12 months in the core CLEAR and CRYSTAL studies could enroll in respective uncontrolled extension studies (NCT01808131; NCT01808144). Patients randomized to LESU200 + XOI or LESU400 + XOI in the core studies who continued on combination therapy in the extension studies were analyzed. Efficacy endpoints included: (1) proportion of patients with complete resolution (CR) of ≥1 target tophus (ie, measurable tophus on hands/wrists and/or feet/ankles 5–20 mm in longest diameter), (2) percent reductions in the total area of all target tophi, and (3) proportion of patients experiencing a gout flare requiring treatment (GFRT).

Results: A total of 239 (LESU200+ALLO) and 232 (LESU400+ALLO) patients continued in the CLEAR extension (n=32 and 33, respectively, with target tophi at baseline); 64 (LESU200+FBX) and 65 (LESU400+FBX) patients continued in the CRYSTAL extension. Proportion of patients with CR of ≥1 target tophus increased from end of core study (1 year) to 2 years: from 25.0% to 43.8% in LESU200+ALLO and 30.3% to 36.4% in LESU400+ALLO, and from 26.6% to 53.1% in LESU200+FBX and 35.4% to 58.5% in LESU400+FBX (LOCF). Percent reduction in the total area of all target tophi versus baseline changed from end of core study to 2 years: from 11.6% to 41.8% in LESU200+ALLO and 42.7% to 49.3% in LESU400+ALLO, and from 54.8% to 68.3% in LESU200+FBX and 58.6% to 72.4% in LESU400+FBX (LOCF). Proportion of patients with a GFRT per month decreased during continued combination treatment in both extension studies (Figure). The proportion of patients with a GFRT during Months 1, 12, and 24 were, respectively, 16.3%, 7.9%, and 5.6% in LESU200+ALLO; 18.1%, 6.9%, and 3.0% in LESU400+ALLO; 26.6%, 10.9%, and 6.3% in LESU200+FBX; and 36.9%, 4.6%, and 1.9% in LESU400+FBX. Extended treatment with LESU + XOI did not result in increased exposure-adjusted incidence rates of adverse events (AEs), AEs leading to discontinuation of lesinurad, serious AEs, or clinical laboratory abnormalities.  

Conclusion: The CLEAR and CRYSTAL extension studies showed that patients treated with lesinurad + XOI for up to 2 years exhibited continued increases in the rate of complete resolution of tophi and reduction in tophus area, as well as decreased rates of gout flares.


Disclosure: T. Bardin, Ipsen, 2,Menarini, 2,AstraZeneca, 5,Ipsen, 5,Menarini, 5,Novartis Pharmaceutical Corporation, 5,Savient, 5,Sobi, 5,Takeda, 5,Cymabay, 5; N. Dalbeth, AstraZeneca, 2,Fonterra, 2,Novartis Pharmaceutical Corporation, 2,AstraZeneca, 8,Teijin, 8,AstraZeneca, 9,Fonterra, 9,Pfizer Inc, 9,Takeda, 9,Crealta, 9,Cymabay, 9; R. Terkeltaub, Ardea Biosciences, Inc., 5,AstraZeneca, 5,Takeda, 5,Relburn, 5,REVIVE, 5; C. Storgard, Ardea Biosciences, Inc., a member of the AstraZeneca Group, 3; M. Fung, Ardea Biosciences, Inc., a member of the AstraZeneca Group, 3; J. Hu, Ardea Biosciences, Inc., a member of the AstraZeneca Group, 3; F. Perez-Ruiz, AstraZeneca, 5,Menarini, 5,Pfizer Inc, 5.

To cite this abstract in AMA style:

Bardin T, Dalbeth N, Terkeltaub R, Storgard C, Fung M, Hu J, Perez-Ruiz F. Clinical Response of Tophus and Flares to Extended Use of Lesinurad in Combination with a Xanthine Oxidase Inhibitor in Patients with Gout [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/clinical-response-of-tophus-and-flares-to-extended-use-of-lesinurad-in-combination-with-a-xanthine-oxidase-inhibitor-in-patients-with-gout/. Accessed February 4, 2023.
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