Efficacy and safety of concurrent collagenase clostridium histolyticum injections for multiple Dupuytren contractures.

J Hand Surg Am

Brisbane Hand and Upper Limb Clinic, Brisbane, Queensland, Australia; the Indiana Hand to Shoulder Center, Indianapolis, IN; the Caboolture Clinical Research Centre, Caboolture, Queensland, Australia; Auxilium Pharmaceuticals, Inc., Chesterbrook, PA; and Auxilium Pharmaceuticals, Inc., Windsor, United Kingdom.

Published: January 2014

Purpose: To assess the safety and efficacy of 2 concurrent injections of collagenase clostridium histolyticum (CCH) in the same hand to treat multiple Dupuytren flexion contractures.

Methods: In a multicenter, open-label phase IIIb study, 60 patients received two 0.58-mg CCH doses injected into cords affecting 2 joints in the same hand during 1 visit, followed by finger extension approximately 24 hours later. Efficacy at postinjection day 30 (change in flexion contracture and active range of motion, patient satisfaction, physician-rated improvement, and rates of clinical success [flexion contracture 5° or less]) and adverse events were summarized.

Results: The 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 the same hand (37%). Mean total (sum of the 2 treated joints) flexion contracture decreased 76%, from 87° to 24° (MCP joints: 86%; PIP joints: 66%). Mean total range of motion increased from 100° to 161°. Clinical success was 76% for MCP joints and 33% for PIP joints. Most patients were very satisfied (60%) or quite satisfied (28%) with treatment. Most investigators rated treated joints as very much improved (55%) or much improved (37%). The most common treatment-related adverse events (> 75% of patients) were contusion, pain in extremity, and edema peripheral (local edema). Most adverse events were mild to moderate in severity. Serious complications included 1 pulley rupture related to study medication and 1 flexor tendon rupture (following conclusion of the study). There were no systemic complications.

Conclusions: Results suggest that 2 affected joints can be effectively and safely treated with concurrent CCH injections. There was an increased incidence of some adverse events with concurrent treatment (pruritus, lymphadenopathy, blood blister, and skin laceration) compared with treatment of a single joint. High degrees of patient satisfaction and physician-rated improvement were reported.

Type Of Study/level Of Evidence: Therapeutic IV.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jhsa.2013.10.002DOI Listing

Publication Analysis

Top Keywords

adverse events
16
pip joints
12
mcp joints
12
joints
10
multiple dupuytren
8
concurrent injections
8
flexion contracture
8
range motion
8
patient satisfaction
8
satisfaction physician-rated
8

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!