A study has examined the safety of intralesional injection of Collagenase Clostridium histolyticum ( CCH; Xiapex ) for the treatment of Peyronie's disease, using a pooled safety analysis of subjects who received at least 1 dose of Collagenase Clostridium histolyticum in any of 6 clinical studies.
Subjects from 6 clinical studies, including 3 randomized, double-blind, placebo-controlled studies and 3 open-label safety and efficacy studies, were included if they had received at least 1 dose of 0.58 mg Collagenase Clostridium histolyticum.
Adverse effects, including treatment-related adverse effects and severe adverse effects, were characterized. Potential immunogenicity-related adverse effects were evaluated through examination of increased anti-AUX-I and anti-AUX-II antibody levels, adverse effects, and reported terms possibly associated with immunological or hypersensitivity events.
Overall, 85.8% of 1044 pooled subjects reported at least 1 treatment-related adverse effects.
The most frequently reported ( greater than or equal to 25.0% of subjects ) treatment-related adverse effects included penile hematoma ( 82.7% had the verbatim penile bruising ), penile pain, and penile swelling.
Most subjects ( 75.2% ) had mild- or moderate-severity treatment-related adverse effects, and 14.2% had no treatment-related adverse effects.
Nine subjects ( 0.9% ) had treatment-related severe adverse effects: 5 with penile hematoma and 4 with corporal rupture.
No association was found between adverse effects and anti-AUX-I or anti-AUX-II antibody levels across treatment cycles, and no systemic hypersensitivity reactions occurred.
In conclusion, this pooled safety analysis has demonstrated that although non-serious and serious treatment-related adverse effects can occur following Collagenase Clostridium histolyticum treatment for Peyronie's disease, most were non-serious and the severe adverse effects were manageable.
Providers should be prepared to manage possible severe adverse effects. ( Xagena )
Carson CC et al, BJU Int 2015; Epub ahead of print