title: The efficacy and safety of collagenase clostridium histolyticum in the treatment of patients with moderate Dupuytren's contracture.
abstract: OBJECTIVE
  The efficacy and safety of collagenase clostridium histolyticum (CCH) in patients with Dupuytren's contracture (DC) was demonstrated in a program including two pivotal phase 3 clinical trials (CORD I and II) which included patients with a broad range of disease severity. This analysis assessed the efficacy and safety of CCH in the subpopulation of DC patients with up to two joints affected and moderate disease according to British Society of Surgery of the Hand classification. This was in support of a resubmission to the Scottish Medicines Consortium.
  
  
  METHODS
  A post-hoc analysis that included data from patients with up to two joints affected and moderate disease treated with CCH during the randomized and open-label phases of CORD I and II.
  
  
  RESULTS
  Of 362 patients who received CCH during the two trials, 58 had one or two joints affected and moderate disease. Sixty-seven joints were treated; 49 patients received treatment for one joint, and 9 patients received treatment for two joints. Each patient received an average of 1.62 injections of CCH per joint. Of 65 evaluable joints, 82% met the primary endpoint of clinical success (reduction in contracture to ≤5° of full extension 30 days after the last injection). This was similar if only primary joints were considered (81% achieved clinical success). Recurrence at 12 months (increase in joint contracture to ≥20° in the presence of a palpable cord in joints that had attained clinical success) was observed in 3.8% of joints. Reported adverse events were mild to moderate in intensity; none resulted in discontinuation.
  
  
  CONCLUSIONS
  CORD I and II show that CCH is well tolerated and effective in the treatment of DC in a broad population. The present analysis suggests that CCH has particular value in patients with moderate severity disease and up to two joints affected.
  
  
  CONCLUSIONS
  This analysis used data from both the randomized and open-label phases of CORD I and II; therefore, it is not possible to present comparative data for this subpopulation. As this was a post-hoc analysis in a relatively small patient subpopulation, statistical comparisons with the full population were not considered appropriate. Furthermore, the small sample size means that additional subgroup analyses, for example of patients by previous treatment or number of injections administered, are not appropriate. Nevertheless, the data presented demonstrate that CCH is both well tolerated and effective in this population when managed by appropriately trained individuals.
authors.affiliation: University Hospital of South Manchester , Manchester , UK.
authors.forename: Duncan A
authors.initials: DA
authors.lastname: McGrouther
authors.forename: Aaron
authors.initials: A
authors.lastname: Jenkins
authors.forename: Stephanie
authors.initials: S
authors.lastname: Brown
authors.forename: Robert A
authors.initials: RA
authors.lastname: Gerber
authors.forename: Piotr
authors.initials: P
authors.lastname: Szczypa
authors.forename: Brian
authors.initials: B
authors.lastname: Cohen
mesh_terms: D000368:Aged; D047009:Hathewaya histolytica / Q000201:enzymology*; D004311:Double-Blind Method; D004387:Dupuytren Contracture / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D003012:Microbial Collagenase / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D003012:Microbial Collagenase