Auxilium Pharmaceuticals has announced three-year recurrence data from the Collagenase Optimal Reduction of Dupuytren's—Long-term Evaluation of Success Study (CORDLESS) for XIAFLEXR (collagenase clostridium histolyticum) in the treatment of adult Dupuytren's contracture patients with a palpable cord.
This five-year observational study was designed to assess the durability of response following treatment with XIAFLEX, as well as long-term safety and progression of disease in patients from earlier Auxilium studies.
At three years, 34.8% of joints that had achieved clinical success had experienced recurrence. Of those patients with affected MP joints, 26.6% of joints that had achieved clinical success had recurrence through three years, while 56.4% of PIP joints that had achieved clinical success had recurrence through three years.
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 two subsequently received a third intervention), and six received XIAFLEX. XIAFLEX has been commercially available in the U.S. only since March 2010.
XIAFLEX recurrence was defined in the AUX-CC-860 clinical study as a 20-degree change in the presence of a palpable cord. 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 increases by at least 30 degrees compared with the reference value with a palpable cord present or, (b) a joint which underwent correction to treat contracture in that joint. Only 22% of patients who had achieved clinical success had experienced recurrence at three years. The recurrence rate for MP joints was 16% and for PIP joints was 39%.