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Safety and Efficacy of Concurrent Collagenase Clostridium Histolyticum Injections to Treat Multiple Dupuytren's Cords
F. Thomas Kaplan, MD1; Stephen Coleman, MBBS2; David Gilpin, MBBS2; Anthony Houston, MBBS3; Gregory J. Kaufman, MD4; Brian M. Cohen, PhD4; Nigel Jones, BSc4;
1Indiana Hand Center, 2Brisbane Hand & Upper Limb Center, 3Redcliffe Hospital, 4Auxilium Pharmaceuticals, Inc

Introduction: Collagenase clostridium histolyticum (CCH) is currently approved in the US for the treatment of adult patients with Dupuytren's contracture with a palpable cord. Injections may be administered at ~4-week intervals. Concurrent administration of 2 injections of CCH into cords in the same hand to treat multiple Dupuytren's fixed flexion contractures (FFC) is investigated for safety and efficacy.

Materials & Methods: Patients with ≥2 contractures in the same hand with palpable cords participated in a multicenter, open-label Phase 3b study and received two 0.58-mg CCH doses injected into cords of two affected joints in the same hand during the same visit. Finger extension procedure was performed 24 hours after CCH administration. Efficacy assessments occurred 30 days following injection, and adverse events (AEs) were recorded throughout. Descriptive statistics were used to report mean percent decrease in FFC, mean increase in range of motion (ROM), and AE rate.

Results: In 60 US and Australian patients (51 male, 9 female) two concurrent injections were most commonly administered in cords affecting metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints on the same finger (47%) or 2 MCP joints on different fingers of same hand (37%). Total (sum of 2 affected and treated joints) FFC at 30 days decreased 75.5%, from 87 to 24. Total ROM increased from 100 to 161. Clinical success following single injection (FFC ≤5) was reached among 76% of MCP joints and 33% of PIP joints. FFC decreased 86% for MCP joints and 66% for PIP joints (Table 1). Most common treatment-related AEs (>75% of patients) were contusion, pain in extremity, and edema peripheral (Table 2). Most AEs were mild/moderate in severity. There were two treatment-related serious AEs: one A2-A4 pulley rupture in patient treated for 2 MCP joints in same hand and one incidence of pain resulting in overnight hospitalization. There were no other systemic complications.

Conclusion: The treatment-related AE profile of CCH in the current study appears comparable to the Phase 1-3 clinical trials of CCH for the treatment of DC with a palpable cord. These study results suggest that 2 cords can be effectively and safely treated simultaneously.

Table 1.tif

Table 2.tiff


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