title: Collagenase clostridium histolyticum for dupuytren contracture: patterns of use and effectiveness in clinical practice.
abstract: OBJECTIVE
  To collect data on the real-world effectiveness of collagenase clostridium histolyticum (CCH) during its first year of use following U.S. Food and Drug Administration approval and compare those results with clinical trial efficacy data.
  
  
  METHODS
  This retrospective chart review was conducted at 10 U.S. community and academic practice sites with major experience using CCH. Charts of patients treated with CCH between February and December 2010 were abstracted, and anonymized data were analyzed. Clinical use, including number of injections per cord and effectiveness outcomes (joint contracture and range of motion) were compared with results from 2 registration trials.
  
  
  RESULTS
  Data were collected from 501 patients (74% male; 48% employed; mean [SD] age, 65 [10] y); 463 patients had sufficient data for analysis. We found that 1.08 CCH injections were used per treated joint, compared with a mean of 1.7 injections in registration trials. Ninety-three percent of joints received only 1 injection. The mean (SD) number of visits per injection was 2.92 (1.0). Mean (SD) contracture was reduced by 75% from 49° (21) at baseline to 12° (17), similar to the 71% to 79% reduction in clinical trials. Mean (SD) range of motion was improved by 37° from 44° (20) at baseline to 81° (14), similar to the increase of 35° and 37° in the 2 clinical trials; and 67% of first injections resulted in full correction to 0° to 5°, compared with the clinical trial rate of 39%.
  
  
  CONCLUSIONS
  Despite a lower injection rate, correction of joint contracture and range of motion was similar to findings from clinical trials. Effectiveness reports using this kind of surveillance design could provide patients, physicians, and payers with the information needed to make better treatment and reimbursement decisions.
  
  
  METHODS
  Therapeutic III.
authors.affiliation: Department of Surgery, College of Human Medicine, Michigan State University, Lansing; Marquette General Healthcare, Marquette, MI; Health Economics & Outcomes Research, Auxilium Pharmaceuticals, Inc., Malvern, PA; and Center for Outcomes Research, Nashville, TN. Electronic address: clayton.peimer@mghs.org.
authors.forename: Clayton A
authors.initials: CA
authors.lastname: Peimer
authors.forename: Paul
authors.initials: P
authors.lastname: Skodny
authors.forename: John I
authors.initials: JI
authors.lastname: Mackowiak
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D004387:Dupuytren Contracture / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D003012:Microbial Collagenase / Q000627:therapeutic use*; D008875:Middle Aged; D016059:Range of Motion, Articular / Q000187:drug effects / Q000502:physiology*; D020127:Recovery of Function; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D003012:Microbial Collagenase
keywords: Collagenase clostridium histolyticum; Dupuytren contracture; effectiveness; outcomes