Purpose
To further evaluate the efficacy and safety of an injectable mixed subtype collagenase
for the treatment of Dupuytren’s contracture (DC).
Methods
Patients with flexion deformities of the metacarpophalangeal (MCP) and/or the proximal
interphalangeal (PIP) joints of 20° or greater were randomized in a double-blind,
placebo-controlled trial. Patients completing this phase could enter an open-label
extension phase. The primary efficacy variable was clinical success: contracture correction
to within 5° of normal (normal, 0°). Additional efficacy variables included the time
and number of injections required to achieve success in the primary joint. Recurrence
of contracture to 20° or greater in successfully treated joints and adverse events
(AEs) were recorded.
Results
Thirty-three of 35 patients (mean ± SD, 61 ± 9 y) entering the double-blind phase
completed the study; 19 of them entered the open-label extension. In the double-blind
phase, clinical success of the primary joint was achieved in 16 of 23 patients receiving
1 injection and in 21 of 23 patients receiving 3 injections. No placebo-treated patients
achieved joint correction. In the open-label extension, 17 of 19 patients achieved
clinical success in at least 1 joint. The mean number of injections for clinical success
in the double-blind and extension phases was 1.5 and 1.4, respectively; the time to
clinical success ranged between 1 and 29 days. Overall, of 62 joints (31 MCP, 31 PIP)
treated in 35 patients, 54 joints achieved clinical success. Over the 24-month follow-up
period after the last injection, 5 joints had a recurrence. The most frequent treatment-related
AEs were local reactions to injections. AEs were mild and resolved over several weeks.
There were no serious treatment-related AEs.
Conclusions
The collagenase injections safely and effectively corrected MCP and PIP contractures
in patients with 1 or more DC-affected joints. Recurrence rates after treatment appear
to be low. Data suggest that this collagenase appears to be a viable nonsurgical treatment
option for DC.
Type of study/level of evidence
Therapeutic I.
Key words
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Article info
Publication history
Accepted:
April 4,
2007
Received:
January 3,
2007
Footnotes
Supported by BioSpecifics Technologies Corp. Additional support was provided by grants from the US Food and Drug Administration (FDR001437) and the National Institutes of Health (GCRC, M01RR1071002). Editorial support was provided by Auxilium Pharmaceuticals, Inc.
No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.
Identification
Copyright
© 2007 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.
