Efficacy and Safety of Injectable Mixed Collagenase Subtypes in the Treatment of Dupuytren's Contracture

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.