Data from 2 phase 3 studies of lesinurad in combination with allopurinol in gout patients was presented at the American College of Rheumatology (ACR) 2014 annual meeting in Boston.
Two replicate phase 3 studies, CLEAR1 and CLEAR2, sponsored by AstraZeneca, investigated the potential of lesinurad (200 mg or 400 mg oral), a selective uric acid re-absorption inhibitor (SURI), when used in combination with xanthine oxidase (XO) inhibitor allopurinol in symptomatic gout patients not achieving target serum uric acid (sUA) levels on their current allopurinol dose.
The results show that approximately twice as many patients met the primary end point with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0 mg/dL at month 6, compared to those treated with allopurinol alone.
“These phase 3 trials are the first of its kind that demonstrate the potential of combination therapy to provide a future treatment option for gout patients where additional therapy is needed,” according to Patricia Harwood, senior director, US medical affairs, RIA, AstraZeneca.
Gout is a disease state that has had little development in treatment options for patients in the last 30 years, according to Harwood.
“For those where current standard of care is not controlling their serum uric acid levels, lesinurad as a combination therapy with allopurinol represents an opportunity to engage physicians and patients in dialogue around additional treatment options for gout, ultimately helping patients manage their disease,” Harwood.
“Additionally, there has been little development over the last 30 years in treatment options for the millions of gout patients who fail to reach target serum uric acid levels on current standard of care therapy such as allopurinol,” she said.
Research has shown that between 40% to 70% of treated patients do not achieve target sUA levels with current standard of care XO inhibitors as prescribed today and need additional efficacy.
“This reveals a significant unmet medical need in the current gout treatment landscape,” Harwood said.