Auxilium Pharmaceuticals Announces Results from Three Year CORDLESS Extension Study in Dupuytren's Contracture - Nominal Recurrence Rate of 34.8% at Three Years for Joints Previously Treated Successfully with XIAFLEX® -93% of joints that were successfully treated with XIAFLEX did not receive any medical or surgical intervention through three years of follow-up.
Press Release Source: Auxilium Pharmaceuticals, Inc. On Thursday June 30, 2011, 7:00 am EDT
MALVERN, Pa., June 30, 2011 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL - News), a specialty biopharmaceutical company, today announced three year recurrence data from the Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study (CORDLESS) for XIAFLEX® (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, the nominal recurrence rate for the 623 joints previously treated successfully with XIAFLEX was 34.8%.
"In my opinion, the recurrence rate seen with XIAFLEX is comparable with or better than other minimally-invasive treatment options. More importantly, the fingers I have treated with XIAFLEX do not appear to develop scar tissue, as opposed to surgically treated fingers. Scar slows recovery and complicates further treatment," said Dr. Tom Kaplan, of the Indiana Hand to Shoulder Center. "As a result, first-line use of XIAFLEX preserves all of my treatment options for those patients who do recur."
Data from the XIAFLEX Three Year Follow-up
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.
Recurrence per protocol definition of >20 degrees or medical intervention
All Joints
MP Joints
PIP Joints
Patients from all phase III studies (n=950)
1,568
920
648
Patients enrolled in extension studies (n=643)
1,080
648
432
Patients successfully treated and enrolled in extension study (n=478)
623
451
172
Joints 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 retreated 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 literature
Although 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 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. By this definition of recurrence, 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%.
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