ULORIC (febuxostat) Demonstrated Efficacy For Management of Hyperuricemia in Patients with Gout


Additional analysis showed that reduction and long-term maintenance of normal serum urate levels also reduced risk of future gout flares.

Philadelphia, October 17, 2009 — Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC® (febuxostat) treatment.

A subset of subjects from the CONFIRMS trial who received prior urate-lowering therapy for up to five years achieved sUA <6.0 mg/dL more often, and had a lower rate of acute gout flares than patients who had not received prior long-term urate-lowering therapy.

According to Michael Becker, M.D., professor emeritus of medicine, rheumatology section, The University of Chicago School of Medicine, gout associated with hyperuricemia is a chronic condition that requires long-term management. “One of the hallmarks of gout is the painful and disabling acute flare of arthritis that patients experience. The results of the CONFIRMS trial suggest that by achieving and maintaining sUA <6.0 mg/dL over time the risk of future gout flares can be diminished.”

Study Design & Results:

Baseline (BL) Characteristics of Gout Subjects Influence Urate-Lowering (UL) Efficacy During Febuxostat and Allopurinol Treatment

The CONFIRMS trial randomized 2,269 patients with gout and sUA =8.0 mg/dL to receive six months of daily treatment with ULORIC 40 mg, 80 mg or allopurinol 300 mg (or 200 mg if baseline estimated creatinine clearance was <60 mL/min). Effects of BL subject characteristics on achievement of sUA <6.0 mg/dL at the final visit were evaluated.

Results from this study showed that 45 percent of the ULORIC 40 mg group and 67 percent of the ULORIC 80 mg group achieved sUA <6.0 mg/dL at their final visit, compared with 42 percent of the allopurinol group.

In subjects with BL moderate renal impairment (estimated creatinine clearance 30 to 59 mL/min), ULORIC 40 mg resulted in a significantly higher response rate than was the case in subjects receiving allopurinol 200 mg (p<0.05).

Documentation of Fewer Gout Flares After Long-Term Urate-Lowering Treatment

Researchers also examined gout flare rates among patients in the CONFIRMS trial and from a subset of 276 patients who had previously participated in the five-year FOCUS or three-year EXCEL trials maintaining sUA <6.0 mg/dL for up to five years while receiving ULORIC 40 mg, 80 mg or 120 mg or allopurinol 300 mg. Patients were randomized by renal function and whether or not patients had already participated in long-term urate-lowering therapy studies. Patients also received gout flare prophylaxis with colchicine or naproxen throughout the six-month study.

Patients who had previously received long-term urate-lowering therapy with ULORIC 40 mg, ULORIC 80 mg or allopurinol achieved goal range sUA (<6.0 mg/dL) more often (57 percent, 77 percent and 52 percent, respectively) than patients who had not received long-term urate-lowering therapy (43 percent, 66 percent and 41 percent, respectively) and had lower rates of acute gout flares (p=0.0001).

Rates of adverse events were similar regardless of prior participation with the most frequent being upper respiratory infection, abnormal liver function tests, musculoskeletal pain and diarrhea.

Overall study results from the CONFIRMS trial demonstrated ULORIC 80 mg was superior in lowering sUA levels compared to ULORIC 40 mg and allopurinol 300 mg (67 percent, 45 percent and 42 percent, respectively).

About Gout and Uric Acid

Gout is the most common inflammatory arthritis in men. According to the National Health and Nutrition Examination Survey III 1988-1994, an estimated 5.1 million Americans suffer from gout. It is a chronic condition associated with hyperuricemia and is characterized by attacks, or “flares,” marked by intense pain, redness, inflammation and warmth in the affected joint. These symptoms are the result of an acute inflammatory response to the presence of urate crystals in the joint(s). As the disease progresses, attacks may become more frequent and patients may develop large urate crystal deposits, known as tophi, in the skin, joints and bones. Tophi can result in joint deformity.

Uric acid is an end-product created when the body breaks down naturally occurring substances called purines. Hyperuricemia occurs when either overproduction or underexcretion of uric acid or a combination of the two leads to elevated urate levels in the body. Hyperuricemia is a precursor of gout, and the risk for developing gout increases with increasing sUA.

ULORIC® is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals America, Inc.


ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

Important Safety Information

· ULORIC is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

· An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including ULORIC. If a gout flare occurs during treatment, ULORIC need not be discontinued.

Prophylactic therapy (i.e. - NSAIDs or colchicine) upon initiation of treatment may be beneficial for up to six months.

·Cardiovascular Events: In randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with ULORIC [0.74 per 100 P-Y (95% CI 0.36-1.37)] than allopurinol [0.60 per 100 P-Y (95% CI 0.16-1.53)]. A causal relationship with ULORIC has not been established. Monitor for signs and symptoms of MI and stroke.

· Liver Enzyme Elevations: In randomized controlled studies, transaminase elevations greater than 3 times the upper limit of normal (ULN) were observed (AST: 2%, 2%, and ALT: 3%, 2% in ULORIC and allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted. Laboratory assessment of liver function is recommended at, for example, 2 and 4 months following initiation of ULORIC and periodically thereafter.

· Adverse reactions occurring in at least 1% of ULORIC-treated patients, and, at least 0.5% greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash.

Please see complete Prescribing Information and visit the ULORIC Web site at www.uloric.com.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc., and Takeda Global Research & Development Center, Inc., are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit www.tpna.com .

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