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.

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 (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: Culley C Carson 3rd, Hossein Sadeghi-Nejad, James P Tursi, Ted M Smith, Gregory J Kaufman, Kimberly Gilbert, Stanton C Honig
• Journal: BJU international (BJU Int) Vol. 116 Issue 5 Pg. 815-22 (Nov 2015) ISSN: 1464-410X [Electronic] England
• PMID: 25818264 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

Chemical References

• Microbial Collagenase

Topics

• Adult
• Aged
• Aged, 80 and over
• Clinical Trials as Topic
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Follow-Up Studies
• Humans
• Injections, Intralesional
• Male
• Microbial Collagenase (administration & dosage)
• Middle Aged
• Penile Induration (drug therapy, physiopathology)
• Penis (drug effects, pathology)
• Randomized Controlled Trials as Topic
• Treatment Outcome