Photo Credit: Staras

A combination therapy of febuxostat and ruzinurad has been helpful for some patients with gout and hyperuricemia to reach their serum uric acid level goals.

Adding the uricosuric ruzinurad to febuxostat led to a significant proportion of patients reaching their serum uric acid (sUA) goal of ≤360 µmol/L. On the higher dose, 56.9% of patients successfully achieved this sUA level, and 43.1% hit the threshold of ≤300 µmol/L.

Dr. Huihua Ding, MD, from Shanghai Jiao Tong University, in China, presented a 12-week phase 2 study (NCT05513976) that investigated ruzinurad as an add-on medication for patients with primary gout and hyperuricemia, who failed to meet their target sUA level on febuxostat alone. In three study groups, patients received febuxostat plus placebo or ruzinurad that was up titrated to five mg or 10 mg daily.

The mean age of the 151 randomly assigned participants varied between 34.6 and 38.5, and over 95% were men. The mean sUA ranged from 504.8 to 514.1 µmol/L. More than 96% of participants were on a 40 mg dose of febuxostat and two-thirds had an eGFR under or equal to 90 ml/min.

At week 12, 56.9% in the 10 mg (OR 8.7; 95% CI 3.3–23.3) and 53.1% in the 5 mg group (OR 7.1; 95% CI 2.7–18.9) attained the primary endpoint of a sUA (≤360 µmol/L) in contrast to 13.7% on placebo (P<0.001 for both comparisons). This translated into sUA differences of -37.7% (10 mg), -30.1% (5 mg) and -8.7% (placebo). Proportions of 43.1% (P<0.001) and 38.8% (P<0.001) versus 9.8% achieved an sUA (≤300 µmol/L). As most AEs were mild-to-moderate, Dr. Ding deemed ruzinurad generally well-tolerated with a manageable safety profile.

“The present study meets its primary objectives, i.e. superiority of ruzinurad plus febuxostat over placebo plus febuxostat in the achievement rate of sUA (≤360 µmol/L) in patients with primary gout and hyperuricemia uncontrolled on febuxostat alone,” Dr Ding summarized.