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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

patients who reported two or more flares by 66% (p<0.0001).

Detailed data from both the PRE-SURGE 2 and RE-SURGE studies will be presented at future scientific conferences.  The safety and efficacy of ARCALYST in the gout setting have not been evaluated by the U.S. Food and Drug Administration.  ARCALYST is not approved for use in gout.

About the PRE-SURGE 2 StudyThe Global PRE-SURGE 2 (PREventative Study against URate-lowering drug-induced Gout Exacerbations) study was a double-blind, placebo-controlled study which evaluated the number of gout flares per patient over the first 16 weeks following initiation of allopurinol therapy.  The trial was conducted in South Africa, Germany, and parts of Asia. In the trial, a gout flare was defined as patient-reported acute articular pain typical of a gout attack that was deemed (by the patient and/or the investigator) to require treatment with an anti-inflammatory therapeutic and involved at least three of four signs/symptoms (joint swelling, redness, tenderness, and pain) and one or more of the following: rapid onset of pain, decreased range of motion, joint warmth, or other symptoms similar to a prior gout flare.  A total of 248 patients were randomized on a 1:1:1 basis to receive one of the following treatment regimens:

  • ARCALYST 160 mg as an initial subcutaneous loading dose, followed by weekly 80 mg subcutaneous injections for a total of 16 weeks
  • ARCALYST 320 mg as an initial subcutaneous loading dose, followed by weekly 160 mg subcutaneous injections for a total of 16 weeks
  • Subcutaneous weekly placebo injections for 16 weeks

  • Primary and key secondary endpoint results were as follows:PlaceboARCALYST® (rilonacept) 80 mgARCALYST® (rilonacept) 160 mg n82

    82

    84*Primary endpointMean # of flares per patient (% reduction compared to placebo)1.23

    0.35

    (72% reduction)


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    SOURCE Regeneron Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
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