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ARCALYST® (rilonacept) Meets Primary and All Secondary Endpoints in Second Phase 3 Trial for Prevention of Gout Flares in Patients Initiating Uric Acid-Lowering Therapy
Date:2/28/2011

r of gout flares and patients receiving the 80 mg dose had a 73% decrease compared to the placebo group (p<0.0001).  

ARCALYST also met all secondary endpoints of the study.  Compared to placebo, treatment with ARCALYST reduced the proportion of patients who experienced at least one gout flare during the study period by 65% for ARCALYST 160 mg (p<0.0001) and by 60% for ARCALYST 80 mg (p=0.0002).  Compared to placebo, treatment with ARCALYST reduced the proportion of patients who experienced two or more flares by 88% for ARCALYST 160 mg (p<0.0001) and by 84% for ARCALYST 80 mg (p<0.0001).

Primary and key secondary endpoint results were as follows:PlaceboARCALYST® (rilonacept) 80 mgARCALYST® (rilonacept) 160 mg n79

80

81Primary endpointMean # of flares per patient (% reduction compared to placebo)1.06

0.29

(73% reduction)

(p<0.0001)

0.21

(80% reduction)
(p<0.0001)Key secondary endpointsProportion of patients with greater than or equal to( 1 flare (% reduction compared to placebo) 46.8%

18.8%

(60% reduction)

(p=0.0002)

16.3%

(65% reduction)

(p<0.0001)Proportion of patients with greater than or equal to( 2 flares (% reduction compared to placebo)31.6%

5.0%

(84% reduction)

(p<0.0001)

3.7%

(88% reduction)

(p<0.0001) One patient did not report flare data and was excluded from efficacy analysesOverall, the cumulative rate of infections was 17.3% in patients treated with ARCALYST 160 mg, 18.8% in patients treated with ARCALYST 80 mg, and 22.8% in placebo patients.  No deaths were reported in this study.

Specific adverse events that occurred at a frequency of at least 5% in any study group were: injection site reaction (19.8% with ARCALYST 160 mg, 8.8% with ARCALYST 80 mg, and 1.3% with placebo), upper respiratory tract infection (9.9% with ARCALYST 16
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SOURCE Regeneron Pharmaceuticals, Inc.
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