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, TheUniversity of Chicago School of Medicine, gout associated with hyperuricemia is a chronic conditionthat 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-loweringtherapy (43 percent, 66 percent and 41 percent, respectively) and had lower rates of acute gout flares(p0.0001).
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 inlowering sUA levels compared to ULORIC 40 mg and allopurinol 300 mg (67 percent, 45 percent and 42 percent, respectively).