Collagenase clostridium histolyticum (CCH), marketed as Xiaflex, has demonstrated promising safety and efficacy in treating Peyronie's disease patients who present with ventral curvature. These findings come from early data of a phase 4 retrospective study, presented by Matthew J. Ziegelmann, MD, at the 2024 Sexual Medicine Society of North America Fall Scientific Meeting (SMSNA) in Scottsdale, Arizona.
Ziegelmann, a urologist at Mayo Clinic in Rochester, Minnesota, explained that while CCH is approved for Peyronie's disease with a palpable plaque and at least 30 degrees of penile deformity, the original IMPRESS trials excluded men with ventral curvature due to concerns about urethral proximity. This study aimed to evaluate CCH's effectiveness and safety specifically in patients with ventral curvature, building upon previous single-institution publications.
Study Design and Endpoints
The ongoing multicenter real-world retrospective collaborative research study seeks to include data from 10 to 15 sites. Eligible patients are those at least 18 years old, diagnosed with Peyronie's disease with ventral curvature and a palpable plaque, and treated with CCH from 2014 through the study start date. The primary endpoint is the percent change from baseline in the degree of ventral curvature at the last visit within 6 months post-treatment. Secondary endpoints include the mean change from baseline in ventral curvature and the proportion of patients with ≥30% improvement from baseline in ventral curvature at the last visit within 6 months of final CCH treatment. Adverse event data were also collected.
Interim Results
Interim data from 32 patients were presented at the SMSNA meeting. The median age of participants was 58.0 years (range, 25-75 years). The average baseline curvature in this cohort was 59.6 degrees. Following CCH treatment, the average reduction was 45.4%, bringing the curvature down to 32.3 degrees at the last visit. Furthermore, 68.8% of patients experienced at least a 30% improvement in ventral curvature from baseline.
Safety Profile
Regarding safety, Ziegelmann noted that treatment-related adverse events were consistent with those typically observed when administering collagenase for any curvature directionality. Importantly, no serious adverse events, such as urethral injury or corporal rupture, were reported in this cohort.
Clinical Implications
"Our conclusions are that we have another example of real-world data supporting efficacy and safety of using collagenase for ventral penile curvatures," Ziegelmann stated. "In this cohort, we did not see any adverse events that would preclude us from offering this therapy to the appropriately selected patient, and certainly we're looking forward to continuing to aggregate our data."
