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Efficacy and safety of collagenase clostridium histolyticum injection for dupuytren contracture: Short-term results from 2 open-label studies
Citation
Witthaut, J and Jones, G and Skrepnik, N and Kushner, H and Houston, A and Lindau, TR, Efficacy and safety of collagenase clostridium histolyticum injection for dupuytren contracture: Short-term results from 2 open-label studies, Journal of Hand Surgery, 38, (1) pp. 2-11. ISSN 0363-5023 (2013) [Refereed Article]
Copyright Statement
Copyright 2013 ASSH
DOI: doi:10.1016/j.jhsa.2012.10.008
Abstract
Purpose: The JOINT I (United States) and JOINT II (Australia and Europe) studies evaluated the efficacy and safety of collagenase clostridium histolyticum (CCH) injection for the treatment of Dupuytren contracture. Methods: Both studies used identical open-label protocols. Patients with fixed-flexion contractures of metacarpophalangeal (MCP) (20° to 100°) or proximal interphalangeal (PIP) joints (20° to 80°) could receive up to three 0.58-mg CCH injections per cord (up to 5 total injections per patient). We performed standardized finger extension procedures to disrupt injected cords the next day, with follow-up 1, 2, 6, and 9 months thereafter. The primary end point (clinical success) was reduction in contracture to within 0° to 5° of full extension 30 days after the last injection. Clinical improvement was defined as 50% or more reduction from baseline contracture. Results: Dupuytren cords affecting 879 joints (531 MCP and 348 PIP) in 587 patients were administered CCH injections at 14 U.S. and 20 Australian/European sites, with similar outcomes in both studies. Clinical success was achieved in 497 (57%) of treated joints using 1.2 ± 0.5 (mean ± SD) CCH injections per cord. More MCP than PIP joints achieved clinical success (70% and 37%, respectively) or clinical improvement (89% and 58%, respectively). Less severely contracted joints responded better than those more severely contracted. Mean change in contracture was 55° for MCP joints and 25° for PIP joints. With average contracture reductions of 73% and improvements in range of motion by 30°, most patients (92%) were "very satisfied" (71%) or "quite satisfied" (21%) with treatment. Physicians rated change from baseline as "very much improved" (47%) or "much improved" (35%). The CCH injections were well tolerated, causing no tendon ruptures or systemic reactions. Conclusions: Collagenase clostridium histolyticum was an effective, minimally invasive option for the treatment of Dupuytren contracture of a broad range of severities. Most treated joints (625 of 879) required a single injection. Treatment earlier in the course of disease provided improved outcomes. Type of study/level of evidence: Therapeutic IV. © 2013 American Society for Surgery of the Hand. Published by Elsevier, Inc. All rights reserved.
Item Details
Item Type: | Refereed Article |
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Keywords: | Collagenase clostridium histolyticum, Dupuytren contracture, fixed flexion, nonsurgical, open label |
Research Division: | Biomedical and Clinical Sciences |
Research Group: | Clinical sciences |
Research Field: | Rheumatology and arthritis |
Objective Division: | Health |
Objective Group: | Clinical health |
Objective Field: | Clinical health not elsewhere classified |
UTAS Author: | Jones, G (Professor Graeme Jones) |
ID Code: | 84102 |
Year Published: | 2013 |
Web of Science® Times Cited: | 64 |
Deposited By: | Menzies Institute for Medical Research |
Deposited On: | 2013-04-17 |
Last Modified: | 2014-04-16 |
Downloads: | 0 |
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