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| |  Rilonacept Reduces Gout Flares During Initiation of Urate-Lowering Therapy: Presented at ACR/ARHP By Betty S. Riggs ATLANTA -- November 9, 2010 – Rilonacept significantly reduced the incidence of acute gout flares, which are a significant problem during the early months of urate-lowering therapy, according to researchers presenting here at the 2010 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP). Interleukin-1 blockade with rilonacept also demonstrated an acceptable safety and tolerability profile, noted Robert Terkeltaub, MD, Veterans Affairs Medical Center, San Diego, California, reporting these findings here on November 8. The Preventative Study Against Urate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 1) was a phase 3, double-blind trial that included adults with gout (with at least 6/13 American Rheumatism Association criteria for acute arthritis of primary gout), urate levels of 7.5 mg/dL or higher, and a self-reported history of 2 or more gout flares in the previous year. On day 1 of the PRE-SURGE 1 trial, eligible subjects began receiving allopurinol 300 mg daily (or a lower dose in those with renal dysfunction, with subsequent titration to achieve urate levels under 6 mg/dL), which was continued through the safety follow-up period, ending at 20 weeks. Subjects were randomised to receive 16 weeks of blinded treatment with either weekly subcutaneous injections of placebo (n = 80), rilonacept 80 mg (n = 80), or rilonacept 160 mg (n = 81), receiving a loading dose on day 1. Gout flares were patient-reported, through the use of interactive voice-response diaries. Anti-inflammatory drugs (eg, colchicine and nonsteroidal anti-inflammatories [NSAIDs]), were not allowed for the prevention of flares; however, NSAIDs or oral glucocorticoids could be prescribed for 5 to 10 days at the investigators’ discretion for gout flares while the study drug was continued. Fewer patients on placebo completed the 16-week treatment period (72.5%) compared with those receiving active treatment (80.0% 80-mg group; 86.4% 160-mg group). The primary efficacy endpoint was the mean number of gout flares per patient through week 16. Observed serum urate levels decreased similarly in all 3 groups, with means ranging from 5.4 to 5.7 mg/dL at week 16. At week 16, the mean number of gout flares per patient was significantly lower in both rilonacept groups relative to placebo: 1.06 (84 flares) for placebo; 0.29 (23 flares) for the rilonacept 80-mg group (P <.005 vs placebo); and 0.21 (17 flares) for the rilonacept 160-mg group (P <.0005 vs placebo). Secondary endpoints were the proportion of patients with 1 or more flares, the number of flare days, and the number of days/patient with a pain score greater than 5 (on a scale of 0 = no pain to 10 = severe pain). One or more flares were reported by 46.8% placebo, 18.8% rilonacept 80 mg, and 16.3% of rilonacept 160 mg (P <.0005 for rilonacept 80 mg and rilonacept 160 mg vs placebo). There was a 57% decrease in the mean number of gout-flare days per patient in the rilonacept 80-mg group compared with placebo, and an 82% decrease in the rilonacept 160-mg group. The mean number of gout-flare days per patient was 5.52 for the placebo group, 2.36 for the rilonacept 80-mg group (P <.0001), and 0.98 for the rilonacept 160-mg group (P <.0001). Rilonacept 80 mg resulted in a 60% reduction in the mean number of days per patient with a pain severity score over 5/10 -- from 2.13 days to 0.85 days (P <.0001), and rilonacept 160 mg resulted in an 84% reduction to 0.36 days (P <.0001). The overall incidence of adverse events was similar between placebo (60.8%) and rilonacept 80 mg (61.3%), with a slightly higher incidence in rilonacept 160 mg (65.4%). Injection-site reactions were the most frequent adverse event for the rilonacept 80-mg group (8.8%) and the rilonacept 160-mg group (19.8%) compared with placebo (1.3%). Three patients in each group experienced serious adverse events. Baseline characteristics were similar among treatment groups. More than 90% of the patients in this study were male, and the mean number of flares reported in the prior year was 4.6. Funding for this study was provided by Regeneron Pharmaceuticals, Inc. [Presentation title: Evaluation of Rilonacept for Prevention of Gout Flares During
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