Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


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

Becker1,  M. A., Schumacher Jr.2,  H. R., Chohan1,  S., MacDonald3,  P., Hunt3,  B., Jackson3,  R. L.

University of Chicago, Chicago, IL,
U Penn & VA Med Ctr, Philadelphia, PA,
Takeda Global Research & Development Center, Inc., Deerfield, IL

Purpose:

Compare efficacy, gout flare rates, and safety of 6-month treatment with febuxostat (FEB) or allopurinol (ALLO) between subjects whose gout and hyperuricemia had been successfully treated in prior clinical trials with either FEB or ALLO for 3–5 yrs vs subjects not previously so treated.

Methods:

In the 6-month CONFIRMS trial, 2269 subjects with gout and hyperuricemia were randomized to receive daily FEB 40 or 80 mg or ALLO (300 or 200 mg based on creatinine clearance). A subset of 276 subjects had previously participated in the FOCUS (5 yrs) or EXCEL (3 yrs) trials, maintaining sUA <6 mg/dL for up to 5 yrs while receiving FEB 40, 80, or 120 mg, or ALLO 300 mg. Randomization was stratified by renal function and by participation or lack thereof in the prior long-term urate lowering therapy (ULT) studies. All subjects who had previous ULT washed out for 30 days and had baseline serum urate level (sUA) >=8 mg/dL before participating in CONFIRMS. Subjects received gout flare prophylaxis with colchicine or naproxen throughout the study. Subjects received gout flare prophylaxis with colchicine or naproxen throughout the study.

Results:

The demographic and co-morbid features of subjects in the prior treatment subset did not differ from those of the entire group. The proportion of subjects with prior participation who achieved sUA <6 mg/dL at the final visit in the FEB 40 mg, FEB 80 mg, and ALLO groups was 57%, 77%, and 52%, respectively vs 43%, 66%, and 41%, respectively, among subjects without prior participation (p<=0.05 for comparison of subjects with and without prior participation for each treatment group). The figure shows the proportion of subjects in each treatment group requiring gout flare treatment. Overall, subjects with prior participation in each treatment group had lower rates of flares (p<=0.001) vs those without prior participation. Rates of AEs were similar among subjects with and without prior participation, with the most frequent being URIs, abnormal LFTs, musculoskeletal pain, and diarrhea.

Conclusion:

The subset of subjects who had previously received 3–5 yrs of ULT achieved sUA <6 mg/dL more often and had substantially fewer reported gout flares vs subjects who had not. This demonstrates the clinical benefit of maintaining sUA <6 mg/dL over time in reducing the incidence of subsequent gout flares and supports the likelihood of long-term urate pool depletion during successful ULT.

To cite this abstract, please use the following information:
Becker, M. A., Schumacher Jr., H. R., Chohan, S., MacDonald, P., Hunt, B., Jackson, R. L.; Documentation of Fewer Gout Flares After Long-Term Urate-Lowering Treatment [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1501
DOI: 10.1002/art.26575

Abstract Supplement

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