Safety and tolerability of collagenase Clostridium histolyticum and fasciectomy for Dupuytren's contracture.
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.
College of Human Medicine, Michigan State University, Marquette, MI, USA clayton.peimer@mghs.org.
C A
CA
Peimer
Department of Hand Surgery, University Hospital, Uppsala, Sweden.
S
S
Wilbrand
Pfizer Inc., Groton, CT, USA.
R A
RA
Gerber
Pfizer Inc., New York, NY, USA.
D
D
Chapman
Pfizer Ltd, Surrey, UK.
P P
PP
Szczypa
D004387:Dupuytren Contracture / Q000188:drug therapy* / Q000601:surgery*; D000071938:Fasciotomy; D006801:Humans; D015552:Injections, Intralesional; D003012:Microbial Collagenase / Q000008:administration & dosage*; D016896:Treatment Outcome
D003012:Microbial Collagenase
Collagenase Clostridium histolyticum; Dupuytren’s contracture; fasciectomy; safety