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Analysis of the clinical safety of intralesional injection of collagenase Clostridium histolyticum ( CCH ) for adults with Peyronie's disease ( PD )
Author(s) -
Carson Culley C.,
SadeghiNejad Hossein,
Tursi James P.,
Smith Ted M.,
Kaufman Gregory J.,
Gilbert Kimberly,
Honig Stanton C.
Publication year - 2015
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.13120
Subject(s) - peyronie's disease , medicine , adverse effect , placebo , disease , surgery , gastroenterology , pathology , alternative medicine
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. Patients and 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 ( AE s), including treatment‐emergent AE s, treatment‐related AE s, and serious AE s ( SAE s), were characterised. Potential immunogenicity‐related AE s were evaluated through examination of increased anti‐ AUX ‐I and anti‐ AUX ‐ II antibody levels, AE s, 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 AE s 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 AE s, and 14.2% had no treatment‐related AE s. Nine patients (0.9%) had treatment‐related SAE s: five with penile haematoma and four with corporal rupture. There was no association between AE s 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 AE s can occur after CCH treatment for PD , most were non‐serious and the SAE s were manageable. Providers should be prepared to manage possible SAE s.