Adding lesinurad to allopurinol provided extra benefit vs. allopurinol alone in lowering serum urate (sUA) levels and is an option for patients requiring additional urate-lowering, a study published in Arthritis & Rheumatology reported.

Lesinurad, a selective uric acid reabsorption inhibitor, is given in combination with xanthine oxidase inhibitors. CLEAR 1 (Combining Lesinurad with Allopurinol Standard of Care in Inadequate Responders) was a Phase 3, 12-month, randomized trial (n=603) evaluating lesinurad 200mg or 400mg daily added to allopurinol in patients with sUA above the <6.0mg/dL target. Participants were taking allopurinol ≥300mg with sUA ≥6.5mg/dL at screening and had ≥2 gout flares in the past year.  

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The study’s primary endpoint was proportion of patients achieving sUA <6.0mg/dL at Month 6. Study authors found that lesinurad 200m and 400mg doses added to allopurinol significantly increased proportions of subjects meeting the sUA target vs. allopurinol alone by Month 6 (54.2% and 59.2% vs. 27.9%, respectively; P<0.0001). Regarding secondary endpoints, lesinurad was not significantly superior in rates of gout flares and complete tophus resolution. 

Lesinurad was well-tolerated with the safety profile of the 200mg daily dose similar to allopurinol alone except for higher incidences of predominantly-reversible serum creatinine elevation. 

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