Marie A Badalamente1, Lawrence C Hurst. 1. Department of Orthopedics, State University of New York at Stony Brook, Health Science Center, Stony Brook, NY 11794-8181, USA. mbadalamente@notes.cc.sunysb.edu
Abstract
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 degrees 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 degrees of normal (normal, 0 degrees ). Additional efficacy variables included the time and number of injections required to achieve success in the primary joint. Recurrence of contracture to 20 degrees 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.
RCT Entities:
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 degrees 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 degrees of normal (normal, 0 degrees ). Additional efficacy variables included the time and number of injections required to achieve success in the primary joint. Recurrence of contracture to 20 degrees 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.
Authors: Jörg Witthaut; Andrew G Bushmakin; Robert A Gerber; Joseph C Cappelleri; Marie-Pierre Hellio Le Graverand-Gastineau Journal: Clin Drug Investig Date: 2011-11-01 Impact factor: 2.859