Injectable Collagenase Clostridium Histolyticum: A New Nonsurgical Treatment for Dupuytren's Disease

Purpose The Collagenase Option for the Reduction of Dupuytren's (CORD) II study investigated the efficacy and safety of injectable Xiaflex (collagenase clostridium histolyticum), in patients with Dupuytren's contracture Methods This was a prospective, randomized, placebo-controlled trial with 90-day double-blind and 9-month open-label phases We randomized patients with contractures affecting metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints 2 to 1 to collagenase (0 58 mg) or placebo Cords received a maximum of 3 injections Cord disruption was attempted the day after injection using a standardized finger extension procedure Primary end point was reduction in contracture to 0 degrees to 5 degrees of normal 30 days after the last injection Results We enrolled 66 patients, 45 cords (20 MCP to 25 PIP joints) received collagenase and 21 cords (11 MCP to 10 PIP joints) received placebo in the double-blind phase Statistically significantly more cords injected with collagenase than placebo met the primary end point (44 4% vs 4 8%, p < 001) The mean percentage decrease in degree of joint contracture from baseline to 30 days after last injection was 70 5% +/- 29 2% in the collagenase group and 13 6% +/- 26 1% in the placebo group (p < 001) The mean increase in range of motion was significantly greater in the collagenase (35 4 degrees +/- 17 8 degrees) than m the placebo (7 6 degrees +/- 14 9 degrees, p < 001) group Efficacy after open-label treatment was similar to that after the double-blind phase 50 7% of all joints achieved 0 degrees to 5 degrees of normal More patients were satisfied with collagenase (p < 001) No joint had recurrence of contracture One patient had a flexion pulley rupture and one patient underwent routine fasciectomy to address cord proliferation and sensory abnormality No tendon ruptures or systemic allergic reactions were reported Most adverse events were related to the injection or finger extension procedure Conclusions Collagenase clostridium histolyticum is the first Food and Drug Administration approved, nonsurgical treatment option for adult Dupuytren's contracture patients with a palpable cord that is highly effective and well tolerated (J Hand Surg 2010,35A 2027-2038 (C) 2010 Published by Elsevier Inc on behalf of the American Society for Surgery of the Hand)