title: Analysis of the clinical safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for adults with Peyronie's disease (PD).
abstract: OBJECTIVE
  To examine the safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for the treatment of Peyronie's disease (PD), using a pooled safety analysis of patients who received at least one dose of CCH in any of six clinical studies.
  
  
  METHODS
  Patients from six clinical studies, including three randomised, double-blind, placebo-controlled studies and three open-label safety and efficacy studies, were included if they had received at least one dose of 0.58 mg CCH. Adverse events (AEs), including treatment-emergent AEs, treatment-related AEs, and serious AEs (SAEs), were characterised. Potential immunogenicity-related AEs were evaluated through examination of increased anti-AUX-I and anti-AUX-II antibody levels, AEs, and reported terms possibly associated with immunological or hypersensitivity events.
  
  
  RESULTS
  Overall, 85.8% of 1 044 pooled patients reported at least one treatment-related AE. The most frequently reported (≥25.0% of patients) treatment-related AEs included penile haematoma (82.7% had the verbatim 'penile bruising'), penile pain, and penile swelling. Most patients (75.2%) had mild- or moderate-severity treatment-related AEs, and 14.2% had no treatment-related AEs. Nine patients (0.9%) had treatment-related SAEs: five with penile haematoma and four with corporal rupture. There was no association between AEs and anti-AUX-I or anti-AUX-II antibody levels across treatment cycles, and no systemic hypersensitivity reactions occurred.
  
  
  CONCLUSIONS
  This pooled safety analysis shows that although non-serious and serious treatment-related AEs can occur after CCH treatment for PD, most were non-serious and the SAEs were manageable. Providers should be prepared to manage possible SAEs.
authors.affiliation: Department of Surgery, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Culley C
authors.initials: CC
authors.lastname: Carson
authors.affiliation: Rutgers New Jersey Medical School and Hackensack University Medical Center, Hackensack, NJ, USA.
authors.forename: Hossein
authors.initials: H
authors.lastname: Sadeghi-Nejad
authors.affiliation: Auxilium Pharmaceuticals, Chesterbrook, PA, USA.
authors.forename: James P
authors.initials: JP
authors.lastname: Tursi
authors.affiliation: Auxilium Pharmaceuticals, Chesterbrook, PA, USA.
authors.forename: Ted M
authors.initials: TM
authors.lastname: Smith
authors.affiliation: Auxilium Pharmaceuticals, Chesterbrook, PA, USA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Kaufman
authors.affiliation: Auxilium Pharmaceuticals, Chesterbrook, PA, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Gilbert
authors.affiliation: Department of Urology, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Stanton C
authors.initials: SC
authors.lastname: Honig
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D003012:Microbial Collagenase / Q000008:administration & dosage*; D008875:Middle Aged; D010411:Penile Induration / Q000188:drug therapy* / Q000503:physiopathology; D010413:Penis / Q000187:drug effects / Q000473:pathology*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D003012:Microbial Collagenase
keywords: Peyronie's disease; microbial collagenase; penile induration; safety