title: Dupuytren contracture recurrence following treatment with collagenase clostridium histolyticum (CORDLESS study): 3-year data.
abstract: OBJECTIVE
  To evaluate long-term efficacy and safety of collagenase clostridium histolyticum (CCH) after the third year of a 5-year nontreatment follow-up study, Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study.
  
  
  METHODS
  This study enrolled Dupuytren contracture patients from 5 previous clinical studies. Beginning 2 years after their first CCH injection, we re-evaluated patients annually for joint contracture and safety. Recurrence in a previously successfully treated joint (success = 0° to 5° contracture after CCH administration) was defined as 20° or greater worsening in contracture in the presence of a palpable cord or medical/surgical intervention to correct new or worsening contracture. We assessed partially corrected joints (joints reduced 20° or more from baseline contracture but not to 0° to 5°) for nondurable response, also defined as 20° or greater worsening of contracture or medical/surgical intervention.
  
  
  RESULTS
  Of 1,080 CCH-treated joints (648 metacarpophalangeal [MCP]; 432 proximal interphalangeal [PIP]; n = 643 patients), 623 (451 MCP, 172 PIP) had achieved 0° to 5° contracture in the original study. Of these joints, 35% (217 of 623) recurred (MCP 27%; PIP 56%). Of these recurrences, an intervention was performed in 7%. Of the 1,080 CCH-treated joints, 301 were partially corrected in the original study. Of these, 50% (150 of 301; MCP: 38% [57 of 152]; PIP: 62% [93 of 149]) had nondurable response. We identified no new long-term or serious adverse events attributed to CCH during follow-up. Anti-clostridial type I collagenase and/or anti-clostridial type II collagenase antibodies were reported for 96% or more of patients who received 2 or more CCH injections and 82% who received 1 injection.
  
  
  CONCLUSIONS
  The recurrence rate, which is comparable to other standard treatments, and the absence of long-term adverse events 3 years after initial treatment indicate that CCH is an effective and safe treatment for Dupuytren contracture. Most successfully treated joints had a contracture well below the threshold for surgical intervention 3 years after treatment. Recurrence rates among successfully treated joints were lower than nondurable response rates among partially corrected joints.
  
  
  METHODS
  Therapeutic IV.
authors.affiliation: College of Human Medicine, Michigan State University, Marquette General Healthcare, Marquette, MI 49855, USA. clayton.peimer@mghs.org
authors.forename: Clayton A
authors.initials: CA
authors.lastname: Peimer
authors.forename: Philip
authors.initials: P
authors.lastname: Blazar
authors.forename: Stephen
authors.initials: S
authors.lastname: Coleman
authors.forename: F Thomas D
authors.initials: FT
authors.lastname: Kaplan
authors.forename: Ted
authors.initials: T
authors.lastname: Smith
authors.forename: James P
authors.initials: JP
authors.lastname: Tursi
authors.forename: Brian
authors.initials: B
authors.lastname: Cohen
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Kaufman
authors.forename: Tommy
authors.initials: T
authors.lastname: Lindau
mesh_terms: D000368:Aged; D047009:Hathewaya histolytica / Q000201:enzymology*; D004387:Dupuytren Contracture / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D003012:Microbial Collagenase / Q000008:administration & dosage*; D008875:Middle Aged; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D003012:Microbial Collagenase