Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie’s Disease

Abstract

Purpose: To assess the long-term safety and immunogenicity profile of collagenase clostridium histolyticum (CCH) and characterize penile curvature deformity over time in patients previously treated for Peyronie’s disease (PD). Materials and Methods: This phase 4 study included men who received CCH in either 12-month, double-blind, placebo-controlled clinical trials (IMPRESS I/II), or one of two 9-month open-label studies. Eligible patients received no additional CCH treatment and were followed once yearly for up to 5 years to assess PD clinical symptoms, patient-reported outcomes, and safety. Results: Of 280 patients enrolled, 204 (73%) completed the study. At baseline, patients (n=247) had already experienced mean penile curvature decrease from 51.8±15.0° to 31.0±16.1° (improvement of 20.9±16.2° or 39.5%). At Year 5 (n=180), despite no additional treatment, there was an additional 9.1% improvement in mean penile curvature compared with Reference data (4.3±13.4°; 95% CI, 2.3-6.2°; p<0.02). At baseline, patients (n=183) experienced mean Peyronie’s Disease Questionnaire (PDQ) bother domain score improvement from 6.5±3.5 to 3.4±3.3. At Year 5, there was additional score improvement to 2.4±2.9 (p=0.0003). Adverse events (AEs) were reported in 17.5% (49/280) of patients, but no AEs were considered treatment-related. No long-term safety issues were identified up to 5 years posttreatment. Long-term immunogenicity profiling showed a decreasing trend in the number of anti–AUX-I and anti–AUX-II seropositive patients at Years 4 and 5 after CCH treatment. Conclusions: Most CCH-treated patients continued to have penile curvature and PDQ domain score improvements through Year 5 without additional CCH treatment, and no additional safety signals were identified.