Safety and tolerability of collagenase Clostridium histolyticum and fasciectomy for Dupuytren's contracture

摘要

Safety was evaluated for collagenase Clostridium histolyticum (CCH) based on 11 clinical trials (N = 1082) and compared with fasciectomy data in a structured literature review of 48 European studies (N = 7727) for treatment of Dupuytren's contracture. Incidence of adverse events was numerically lower with CCH vs. equivalent complications from fasciectomy (median range incidence), including nerve injury (0 vs. 3.8 0-50+), neurapraxia (4.4 vs. 9.4 0-51.3), complex regional pain syndrome (0.1 vs. 4.5 1.3-18.5) and arterial injury (0 vs. 5.5 0.8-16.5). Tendon injury (0.3 vs. 0.1 0-0.2), skin injury (16.2 vs. 2.8 0-25.9) and haematoma (77.7 vs. 2.0 0-25) occurred at a numerically higher incidence with CCH than surgery. Adverse events in CCH trials not reported after fasciectomy included peripheral oedema; extremity pain; injection site pain, haemorrhage and swelling; tenderness; pruritus and lymphadenopathy. CCH-related adverse events were reported as predominantly injection-related and transient. These results may support clinical decision-making for treatment of Dupuytren's contracture.