1657 SUBGROUP ANALYSIS OF CURVATURE DEFORMITY SEVERITY AND SYMPTOM BOTHER IMPROVEMENT IN PATIENTS WITH PEYRONIE'S DISEASE BEING TREATED WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM IN CLINICAL STUDIES

Abstract

INTRODUCTION AND OBJECTIVES: The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies (IMPRESS) I and II examined the clinical efficacy of collagenase clostridium histolyticum (CCH) in subjects with Peyronie’s disease (PD). The effect of CCH on penile curvature deformity severity and the PD symptom bother score using the Peyronie’s disease questionnaire (PDQ) was evaluated in different patient populations. METHODS: Subjects 18 years of age with PD symptoms for 12 months and penile curvature deformity of 30° to 90° were enrolled in the identical randomized, double-blind, placebo-controlled, phase 3 IMPRESS studies. Subjects received up to 8 injections of 0.58 mg CCH, two injections per cycle separated by approximately 24 to 72 hours, with the second injection followed 24-72 hours later by plaque modeling. Each cycle was separated by a period of 6 weeks. A subgroup analysis was performed to analyze the effect of age, concomitant diabetes mellitus (DM), and previous penile trauma on outcomes following treatment at Week 52. RESULTS: A total of 401 CCH-treated subjects combined from IMPRESS I and II with at least one penile curvature measurement and PDQ response recorded were included. Outcomes by age are shown in Table 1. Patients with DM treated with CCH experienced a mean improvement in penile curvature of 17.2° (34.4%) versus 17.0° (34.0%) in those without DM. The mean improvement in PD symptom bother for the two groups was 2.7 and 2.9, respectively. Subjects with or without a history of penile trauma treated with CCH experienced a mean improvement in penile curvature of 17.9° (35.1%) vs 16.7° (33.7%), respectively. The improvement in PD symptom bother was 3.0 in subjects with a history of penile trauma and 2.8 in those without. CONCLUSIONS: Improvements in penile curvature and PD symptom bother score were realized regardless of age, concomitant diabetes, or history of penile trauma. Overall, CCH improved the psychosexual and physical symptoms of PD in diverse patient populations.