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Results of Study of Febuxostat on the Frequency of Acute Gout Flares in Early Gout

November 14, 2016

First Clinical Trial Investigating the Effect of Urate-Lowering Therapy on Gout Flares in Early Gout

DEERFIELD, Ill., November 14, 2016 – Today Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”), announced Phase 2 study data evaluating febuxostat use in patients with early gout at the American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals (ARHP) Annual Meeting taking place from November 11-16, 2016, in Washington, DC.

The findings were presented as a late-breaking poster entitled “Overall Reduction in Acute Flares During Treatment with Febuxostat Compared with Placebo Over 2 Years in Patients with Early Gout.” The study is the first clinical trial investigating the frequency of acute flares in early gout.

The study examined the frequency of acute flares in 314 patients with early gout dosed with febuxostat (n=157) versus placebo (n=157) during a two-year period. All patients had early gout, defined as having experienced two or fewer gout flares in total and only one flare during the previous 12 months.

Over the entire study duration, the percentage of patients with at least one flare was significantly lower in the febuxostat group than in the placebo group (29.3% vs 41.4%, respectively; p<0.05). During the first six months, the febuxostat group showed a slightly higher percentage of patients with at least one flare, which was not statistically significant (17.2% vs 13.4%, respectively; patients also received gout flare prophylaxis during this time). The percentage of patients with at least one flare in the placebo vs. febuxostat groups was 27.9% vs. 13.5% (p<0.01) at months 6-12, 21.7% vs. 10.3% (p<0.05) at months 12-18, and 16.5% vs. 5.9% (p<0.05) at months 18-24.

Takeda’s ULORIC® (febuxostat) was approved by the U.S. Food and Drug Administration (FDA) in 2009 and is used to lower blood uric acid levels in adults with gout.

Important Safety Information for ULORIC

Do not take ULORIC if you are taking Azathioprine or Mercaptopurine.

Your gout may flare up when you start taking ULORIC; do not stop taking your ULORIC even if you have a flare. Your healthcare provider may give you other medicines to help prevent your gout flares.

A small number of heart attacks, strokes, and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these events.

Tell your healthcare professional about liver or kidney problems or a history of heart disease or stroke.

Your healthcare professional may do blood tests to check your liver function while you are taking ULORIC.

The most common side effects of ULORIC are liver problems, nausea, gout flares, joint pain, and rash. Tell your healthcare professional if you develop a rash, have any side effect that bothers you, or that does not go away.


ULORIC is a prescription medicine used to lower blood uric acid levels in adults with gout. ULORIC is not for the treatment of high uric acid without a history of gout.

Individual results may vary.
Please see the complete Prescribing Information and talk to your healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Gouty Arthritis
Gout is caused by a buildup of uric acid in the body. Uric acid forms crystals in the joints, which can lead to the inflammation and pain of a gout attack. As the uric acid level rises, so does the chance for gout and gout attacks. Over time, these attacks, or flares, can involve more joints, last longer, and happen more often.

An estimated 8.3 million Americans have gout, which may be increasing. Half of gout patients have three or more attacks per year; a typical gout attack can last at least 4 days. 

About Takeda Pharmaceutical Company 
Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the U.S. marketing and sales organization of Takeda Pharmaceutical Company Limited.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.


Linda Calandra
Takeda Pharmaceuticals U.S.A., Inc.
[email protected]