title: Dupuytren Contracture Recurrence Following Treatment With Collagenase Clostridium histolyticum (CORDLESS [Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study]): 5-Year Data.
abstract: OBJECTIVE
  Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study was a 5-year noninterventional follow-up study to determine long-term efficacy and safety of collagenase clostridium histolyticum (CCH) treatment for Dupuytren contracture.
  
  
  METHODS
  Patients from previous CCH clinical studies were eligible. Enrolled patients were evaluated annually for contracture and safety at 2, 3, 4, and 5 years after their first injection (0.58 mg) of CCH. In successfully treated joints (≤ 5° contracture following CCH treatment), recurrence was defined as 20° or greater worsening (relative to day 30 after the last injection) with a palpable cord or any medical/surgical intervention to correct new/worsening contracture. A post hoc analysis was also conducted using a less stringent threshold (≥ 30° worsening) for comparison with criteria historically used to assess surgical treatment.
  
  
  RESULTS
  Of 950 eligible patients, 644 enrolled (1,081 treated joints). At year 5, 47% (291 of 623) of successfully treated joints had recurrence (≥ 20° worsening)-39% (178 of 451) of metacarpophalangeal and 66% (113 of 172) of proximal interphalangeal joints. At year 5, 32% (198 of 623) of successfully treated joints had 30° or greater worsening (metacarpophalangeal 26% [119 of 451] and proximal interphalangeal 46% [79 of 172] joints). Of 105 secondary interventions performed in the successfully treated joints, 47% (49 of 105) received fasciectomy, 30% (32 of 105) received additional CCH, and 23% (24 of 105) received other interventions. One mild adverse event was attributed to CCH treatment (skin atrophy [decreased ring finger circumference from thinning of Dupuytren tissue]). Antibodies to clostridial type I and/or II collagenase were found in 93% of patients, but over the 5 years of follow-up, this did not correspond to any reported clinical adverse events.
  
  
  CONCLUSIONS
  Five years after successful CCH treatment, the overall recurrence rate of 47% was comparable with published recurrence rates after surgical treatments, with one reported long-term treatment-related adverse event. Collagenase clostridium histolyticum injection proved to be an effective and safe treatment for Dupuytren contracture. For those receiving treatment during follow-up, both CCH and fasciectomy were elected options.
  
  
  METHODS
  Therapeutic II.
authors.affiliation: College of Human Medicine, Michigan State University, East Lansing, MI; UP Health System-Marquette/Duke-LifePoint, Marquette, MI. Electronic address: peimer@msu.edu.
authors.forename: Clayton A
authors.initials: CA
authors.lastname: Peimer
authors.affiliation: Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA.
authors.forename: Philip
authors.initials: P
authors.lastname: Blazar
authors.affiliation: Hand and Upper Limb Clinic, Brisbane, Queensland, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Coleman
authors.affiliation: Indiana Hand to Shoulder Center, Indianapolis, IN.
authors.forename: F Thomas D
authors.initials: FT
authors.lastname: Kaplan
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
authors.forename: Ted
authors.initials: T
authors.lastname: Smith
authors.affiliation: Pulvertaft Hand Centre, Royal Derby Hospital, Derby, UK.
authors.forename: Tommy
authors.initials: T
authors.lastname: Lindau
mesh_terms: D000368:Aged; D047009:Hathewaya histolytica; D004387:Dupuytren Contracture / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D003012:Microbial Collagenase / Q000627:therapeutic use*; D008875:Middle Aged; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003012:Microbial Collagenase
keywords: Collagenase clostridium histolyticum; Dupuytren contracture; recurrence; safety