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Auxilium Pharmaceuticals Announces Additional Data from Three-Year XIAFLEX® Recurrence Study in Dupuytren's Contracture in E-poster at ASSH Meeting
Date:9/8/2011

nal recurrence rate for the 623 joints previously treated successfully with XIAFLEX was 34.8%. 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 with some interventions occurring in advance of its availability.

Through three years of follow-up, the adverse event profile of XIAFLEX treated joints demonstrated a local adverse event profile similar to previous first-line clinical studies and revealed no new long-term adverse events. One retreated patient reported a serious adverse event of a motor vehicle accident, which was considered unrelated to drug. 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.

Recurrence with XIAFLEX as defined by greater than or equal to 30 degrees standard used in surgical literature

Although there is no standard methodology to measure recurrence, some literature (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
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SOURCE Auxilium Pharmaceuticals, Inc.
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