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Auxilium Pharmaceuticals Announces Results from Three Year CORDLESS Extension Study in Dupuytren's Contracture
Date:6/30/2011

0

648Patients enrolled in extension studies (n=643)

1,080

648

432Patients successfully treated and enrolled in extension study (n=478)

623

451

172Joints with recurrence at 1 year (n/%)

19/623 (3.0%)

8/451 (1.8%)

11/172 (6.4%)Joints with recurrence at 2 years (n/%)

122/623(19.6%)

64/451(14.2%)

58/172(33.7%)Joints with recurrence at 3 years (n/%)

217/623 (34.8%)

120/451 (26.6%)

97/172 (56.4%)The study also tracks whether a joint successfully treated with XIAFLEX received any further medical intervention.  Through year three of follow-up 93.1% of joints that were successfully treated with XIAFLEX did not receive any medical or surgical intervention. Of the 43 (6.9 %) successfully treated joints that received medical or surgical intervention through three years, 30 had surgery, seven received needle aponeurotomy (of which 2 subsequently received a third intervention), and six received XIAFLEX.  XIAFLEX has been commercially available in the U.S. only since March 2010.

Other Top-Line Findings through Three Years:

  • High severity PIP joints (those with baseline contractures > 40 degrees) had a statistically significant higher recurrence rate than low severity PIP joints (71% versus 50%, respectively).  Combined with data from the CORD I study this suggests that treatment of PIP joints, before they reach high severity, may be beneficial(1).
  • Recurrence rates in successfully treated MP joints with low severity (those with baseline contractures less than or equal to 50 degrees) and high severity were not statistically different.
  • Sixteen patients in this study have been retreated with XIAFLEX (6 in a previously successfully treated joint and the remainder in previously untreated joints) through three years follow-up, with a local adverse event profile similar to previous first-line clinical studies.  One ret
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  • SOURCE Auxilium Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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    2. Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytrens Contracture
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