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Multiple Collagenase Clostridium Histolyticum Injections into Dupuytren's Cords in a Single Hand Simultaneously
Stephen Coleman, MBBS1; David Gilpin1, MBBS James Tursi, MD2; Greg Kaufman, MD2; Nigel Jones3; Brian Cohen, PhD2; Marguerite Copley, BOccThy4; Nash Naam, MD5
1Hand & Upper Limb Clinic, Brisbane, Australia, 2Auxilium Pharmaceuticals, Inc, Malvern, PA, 3Auxilium Pharmaceuticals, Inc, Windsor, United Kingdom, 4Extend Rehabilitation, Brisbane, Australia, 5Southern Illinois Hand Center and Southern Illinois University, Effingham, IL

Objective: This open-label study was designed to examine the safety, efficacy, and multiple-dose pharmacokinetics (PK) of treating two cords on the same hand simultaneously with collagenase clostridium histolyticum (CCH) in patients with multiple Dupuytren’s contractures (DC).

Methods: A total of 12 subjects with DC, each with at least three contractures caused by palpable cords, were enrolled. Efficacy assessments were taken 30 days after treatment and AEs were recorded throughout. In the first treatment cycle, all subjects were given one dose of CCH (0.58 mg) injected into a single cord. The same subjects entered a second treatment cycle 30 days later, where two different affected joints were treated simultaneously; i.e., patients received two doses of CCH (0.58 mg) in the same hand on the same day. A finger extension procedure, without local anesthetic, was performed 24 hours after each administration of CCH.

Results: Among the 12 subjects, 22 metacarpophalangeal (MP) joints and 14 proximal interphalangeal (PIP) joints were treated. Efficacy results following single and multiple injections are presented below.

*One MP joint with a baseline contracture of 0° was excluded from the analysis

All patients (100%) were either “quite satisfied” or “very satisfied” following both cycles. The most common treatment-related AEs were local edema, contusions, and pain in extremities; in general the AEs had a slightly greater degree of severity after the second treatment cycle. Most AEs resolved within 30 days and no treatment-related serious AEs were reported. No systemic complications were observed and systemic PK samples were below levels of CCH quantification.  

Conclusion: CCH is currently approved in adults with DC for the nonsurgical treatment of a single palpable cord during any 30-day treatment cycle. These results demonstrate that two cords can be treated simultaneously with similar efficacy and safety as when treated individually. The ability to give multiple injections would allow for a more rapid and effective treatment of multiple affected joints, without the need to wait 30 days between treatments, and would constitute a significant advantage for both patient and physician.

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