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

reated patient had a serious adverse event of a motor vehicle accident, which was considered unrelated to drug.
  • The adverse event profile of XIAFLEX treated joints through three years follow-up revealed no new long-term adverse events.
  • Of the 74 serious adverse events reported through three years of follow-up, none were considered related to XIAFLEX and none occurred in the treated finger.

  • "While I am very impressed with the three year recurrence rate of 35% using a 20 degree change to define recurrence, the surgical literature has often defined recurrence as a 30 degree change.  Using this definition, XIAFLEX demonstrates an even lower 22% recurrence rate at three years,” said Dr. Vincent Hentz, Professor Emeritus, Surgery - Plastic/Recon Surgery, Stanford Medical School.  “With this longer term data, I believe that treatment with XIAFLEX of Dupuytren’s patients’ palpable cords can provide durable outcomes with a very acceptable rate of recurrence in the majority of patients.”

    Recurrence with XIAFLEX as defined by greater than or equal to 30 degrees standard used in surgical literatureAlthough there is no standard methodology to measure recurrence, the literature(2,3,4), on surgical treatment does reference a definition of recurrence as a 30 degree worsening of contracture following an intervention.  XIAFLEX recurrence was defined in the AUX-CC-860 clinical study as a 20 degree change in the presence of a palpable cord.  In order to evaluate within the context of the existing surgical literature, the three year XIAFLEX data was examined using a criterion referenced in the literature.  Specifically, for this post hoc analysis, the definition of recurrence was (a) a joint contracture that was successfully treated (had previously achieved a reduction in contracture to five degrees or less at the Day 30 evaluation after the last injection of XIAFLEX) that subsequently increases
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    SOURCE Auxilium Pharmaceuticals, Inc.
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