Auxilium reports positive data from XIAFLEX retrospective commercial patient chart review

Sep 8 2011

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that positive data from a retrospective commercial patient chart review of XIAFLEX® (collagenase clostridium histolyticum) used for the treatment of adult Dupuytren's contracture patients with a palpable cord are available via e-posters at the American Society for Surgery of the Hand meeting in Las Vegas.   In the chart review, 292 patients who received commercial XIAFLEX were followed to determine if real-world use of XIAFLEX resulted in improved outcomes versus results that were reported in the U.S. pivotal phase III double-blind placebo controlled trial of XIAFLEX (CORD I).   Although there are limitations in comparing separate studies head to head, results from the retrospective patient chart review indicated that fewer injections resulted in improved outcomes with XIAFLEX versus reported outcomes from CORD I.  

"These results indicate that trained physicians who are using XIAFLEX in real-world conditions should be able to achieve better outcomes than the clinical trials with less XIAFLEX," said Dr. Gary Pess of Central Jersey Hand Surgery.  "I believe that first-line non-surgical treatment of Dupuytren's patients' palpable cords with XIAFLEX may allow treatment before a patient would be eligible for surgery and can provide durable outcomes with a low rate of recurrence in the majority of patients."  

In abstract 21, the retrospective chart review results indicate that real-world use of XIAFLEX resulted in a higher percentage of patients who achieved release after the first injection than was reported in CORD I, potentially due to use of anesthesia during cord manipulation.  In CORD I, the protocol did not allow anesthesia during manipulation of cords, while anesthesia was used over 92% of the time during manipulations post-marketing from the patient chart review.  Following the first injection of XIAFLEX in the CORD I study, 96% of first-extension visits resulted in a release, with full cord release 39% of the time and partial cord release 57% of the time.  Following the first injection of XIAFLEX in the retrospective patient chart review, 97% of first-extension visits resulted in a release, with full cord release 63% of the time and partial cord release 34% of the time.   The XIAFLEX safety profile in the retrospective patient chart review was consistent with the clinical study profile.

In abstract 23, the retrospective patient chart review results indicate that real-world use of XIAFLEX required fewer injections to achieve equivalent reductions in contracture and final range of motion compared to results reported in CORD I.  According to the XIAFLEX package insert, patients were given a mean number of 1.7 +/- 0.8 XIAFLEX injections per joint.  In the retrospective patient chart review, the mean number of XIAFLEX injections given to patients decreased to 1.09 +/- 0.3 per joint.  Even after fewer injections, chart review patients treated with XIAFLEX achieved equivalent results in contracture, percentage reduction in contracture, final contracture, change in range of motion and final range of motion compared to results reported in CORD I.  

These data will be available starting September 8 via respective e-posters from Dr. Keith Denkler et al. entitled "Variation in Strategies to Achieve Successful Cord Release Following CCH Injection for Dupuytren's Contracture" and from Dr. Phil Blazar et al. entitled "Resource Use Associated with CCH for Dupuytren's Contracture in Actual Practice".  E-posters will be available during the entire meeting via the kiosks in the meeting hall or online at http://tinyurl.com/AM11eposters.   Further analysis of data from the full 501 patient chart review is pending and the Company is seeking publication of additional results in appropriate medical journals.