title: The Efficacy and Safety of Concurrent Collagenase Clostridium Histolyticum Injections for 2 Dupuytren Contractures in the Same Hand: A Prospective, Multicenter Study.
abstract: OBJECTIVE
  To evaluate efficacy and safety of concurrent administration of 2 collagenase clostridium histolyticum (CCH) injections to treat 2 joints in the same hand with Dupuytren fixed flexion contractures (FFCs).
  
  
  METHODS
  Patients with 2 or more contractures in the same hand caused by palpable cords participated in a 60-day, multicenter, open-label, phase 3b study. Two 0.58 mg CCH doses were injected into 1 or 2 cords in the same hand (1 injection per affected joint) during the same visit. Finger extension was performed approximately 24, 48, or 72 or more hours later. Changes in FFC and range of motion, incidence of clinical success (FFC ≤ 5°), and adverse events (AEs) were summarized.
  
  
  RESULTS
  The study enrolled 715 patients (725 treated joint pairs), and 714 patients (724 joint pairs) were analyzed for efficacy. At day 31, mean total FFC (sum of 2 treated joints) decreased 74%, from 98° to 27°. Mean total range of motion increased from 90° to 156°. The incidence of clinical success was 65% in metacarpophalangeal joints and 29% in proximal interphalangeal joints. Most treatment-related AEs were mild to moderate, resolving without intervention; the most common were swelling of treated extremity, contusion, and pain in extremity. The incidence of skin lacerations was 22% (160 of 715). Efficacy and safety were similar regardless of time to finger extension.
  
  
  CONCLUSIONS
  Collagenase clostridium histolyticum can be used to effectively treat 2 affected joints concurrently without a greater risk of AEs than treatment of a single joint, with the exception of skin laceration. The incidence of clinical success in this study after 1 injection per joint was comparable to phase 3 study results after 3 or more injections per joint. Two concurrent CCH injections may allow more rapid overall treatment of multiple affected joints, and the ability to vary the time between CCH injection and finger extension may allow physicians and patients greater flexibility with scheduling treatment.
authors.affiliation: OrthoCarolina, Inc., Charlotte, NC. Electronic address: glenn.gaston@orthocarolina.com.
authors.forename: R Glenn
authors.initials: RG
authors.lastname: Gaston
authors.affiliation: Unit for Hand Surgery, Department of Orthopaedics, Odense University Hospital, Odense, Denmark.
authors.forename: Søren Erik
authors.initials: SE
authors.lastname: Larsen
authors.affiliation: Central Jersey Hand Surgery, Eatontown, NJ.
authors.forename: Gary M
authors.initials: GM
authors.lastname: Pess
authors.affiliation: Brisbane Hand and Upper Limb Clinic, Brisbane, Queensland, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Coleman
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
authors.forename: Brian
authors.initials: B
authors.lastname: Dean
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
authors.forename: Brian M
authors.initials: BM
authors.lastname: Cohen
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Kaufman
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
authors.forename: James P
authors.initials: JP
authors.lastname: Tursi
authors.affiliation: Stony Brook University Medical Center, Stony Brook, NY.
authors.forename: Lawrence C
authors.initials: LC
authors.lastname: Hurst
mesh_terms: D000368:Aged; D047009:Hathewaya histolytica / Q000201:enzymology*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004387:Dupuytren Contracture / Q000000981:diagnostic imaging / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D018737:Hand Strength / Q000502:physiology; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D003012:Microbial Collagenase / Q000008:administration & dosage*; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D016059:Range of Motion, Articular / Q000187:drug effects*; D020127:Recovery of Function; D019233:Retreatment; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D003012:Microbial Collagenase
keywords: Collagenase clostridium histolyticum; Dupuytren disease; concurrent injections; fixed flexion contracture; range of motion