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Nonsurgical Treatment of Dupuytren's Contracture: Three-Year Safety Results Using Collagenase Clostridium Histolyticum
Clayton A. Peimer, MD1; Claudia McGoldrick2; Gregory J. Kaufman, MD2
1College of Human Medicine, Michigan State University, Marquette, MI; 2Auxilium Pharmaceuticals, Inc, Chesterbrook, PA

INTRODUCTION: Collagenase clostridium histolyticum (CCH, XIAFLEX®, XIAPEX®) is approved for treatment of adults with Dupuytren's contracture with a palpable cord. This analysis aimed to determine if adverse events (AEs) observed through 3 years after approval are similar to those observed in the first year of postmarketing surveillance.

MATERIALS AND METHODS: The current analysis is based on postmarketing safety data reported to Auxilium between 2/2/2010 and 2/2/2013, including reports of tendon rupture, ligament injury/rupture, and nerve injury.

RESULTS: The AEs reported during the first 3 years of global postmarketing surveillance are similar in type and incidence to those reported in the first year. Approximately 49,078 injections of CCH were administered during this time. An estimated 1,732 AEs were reported in 846 patients and were most commonly localized, nonserious reactions, including skin tears, contusion, peripheral edema, pain in extremity, and injection site reactions (Table 1). There were 19 reports of skin grafts among 228 patients who experienced skin tear post-injection; 11/19 were considered to be associated with the finger manipulation procedure and most commonly occurred in treatment of the fifth finger proximal interphalangeal (PIP) joint. There were 26 reports of tendon rupture at a rate of 0.05% (26/49,078 injections), and 1 report each of A2 pulley injury, stretch neuropraxia (numbness without pain away from injection site following full extension), and ligament injury. Of the 17 tendon ruptures for which joint and finger can be identified, most occurred in the fifth finger (5 metacarpophalangeal [MCP], 8 PIP) (Table 2). There were also 2 reported cases of complex regional pain syndrome (reflex sympathetic dystrophy); one of which resolved within 3 months.

CONCLUSIONS: Three-year postmarketing surveillance shows a safety profile consistent with the published 1-year postmarketing surveillance. The frequency of skin tear is consistent with previously reported literature and majority of skin tears resolved without skin graft. Tendon ruptures occurred rarely and appeared to occur predominantly in the fifth finger. Postmarketing surveillance provides valuable insight into the safety of CCH when used in clinical practice and outside of the context of clinical trial protocols. However, voluntary reporting systems typically underreport AEs.




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