IMPRESS I and II support the clinical efficacy and safety of collagenase C. histolyticum for the physical and psychological aspects of Peyronie disease.

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This study confirms the conceptual framework, factor structure, and convergent and discriminant validity of the PDQ psychological and physical symptoms, penile pain, and symptom bother domains. Used in conjunction with objective penile curvature measurements, the PDQ can serve as a valuable diagnostic tool or outcome measure to assess treatment related improvements in Peyronie's disease symptoms.

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Introduction Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration-approved, intralesional treatment for Peyronie’s disease (PD). Aim The aim of this study was to assess the safety and effectiveness of CCH in the treatment of PD. Methods This phase 3, open-label study enrolled subjects who were CCH-naïve, were enrolled in a previous pharmacokinetic study, or had received placebo in an earlier phase 2 CCH study. Each treatment cycle included two intralesional injections of CCH 0.58 mg, approximately 24–72 hours apart, and plaque modeling 24–72 hours after the second injection of each cycle. The treatment cycle was repeated after 6 weeks for ≤4 treatment cycles. Main Outcome Measures The co-primary end points were the mean percent change in penile curvature deformity and the mean improvement in PD bother score (range 0–16) from baseline to week 36. Results Of the 347 subjects treated with ≥1 injection, 238 had both a penile curvature measurement and a Peyronie’s Disease Questionnaire response at baseline and ≥1 subsequent time point. Mean baseline penile curvature deformity was 53.0° and mean PD symptom bother was 7.3. Statistically significant mean improvements from baseline to week 36 were observed in both penile curvature deformity (34.4% [95% confidence interval {CI}, 31.2%, 37.6%]) and PD symptom bother score (3.3 [95% CI, 2.8, 3.7]). Most adverse events (AEs) were mild or moderate in severity and local to the penis. There were three serious treatment-related AEs, two penile hematomas and one corporal rupture; all resolved with treatment. Conclusions Potentially clinically meaningful and statistically significant improvements in penile curvature deformity and PD symptom bother scores were observed with intralesional injection of CCH compared with baseline in men with PD. CCH was generally well tolerated, with AEs primarily transient and local to injection site. In conjunction with previous studies, the results of this open-label study support the use of CCH in the treatment of PD.

ObjectivesTo examine the efficacy of intralesional collagenase Clostridium histolyticum (CCH) in defined subgroups of patients with Peyronie's disease (PD). Patients and MethodsThe efficacy of CCH compared with placebo, assessed from baseline to week 52, was examined in subgroups of participants from the Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies (IMPRESS) I and II. ResultsReductions in penile curvature deformity and PD symptom bother were observed in all subgroups. Penile curvature deformity reductions were significantly greater with CCH than with placebo for the following subgroups: baseline penile curvature 30-60°and 61-90°; disease duration >2 to ≤4 years and >4 years; no calcification; and IIEF score ≥17 (high IIEFerectile function score; P < 0.05 for all). PD symptom bother reductions were significantly greater in the CCH group for: penile curvature 30-60°; disease duration >4 years; no calcification; and IIEF score 1-5 (no sexual activity) and ≥17 (P < 0.05 for all). ConclusionsIn this analysis, clinical efficacy of CCH treatment for reducing penile curvature deformity and PD symptom bother was found across subgroups. In the IMPRESS I and II overall, adverse events (AEs) were typically mild or moderate, although treatment-related serious AEs, including corporal rupture or penile haematoma, occurred. Future studies could be considered to directly assess the efficacy and safety of CCH treatment in defined subgroups of PD patients, with the goal of identifying predictors of optimum treatment success.

ObjectiveTo 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 MethodsPatients 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. ResultsOverall, 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. ConclusionsThis 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. Keywordspenile induration, Peyronie's disease, microbial collagenase, safety IntroductionPeyronie's disease (PD) is characterised by the formation of a fibrous collagen scar or plaque of the tunica albuginea, resulting in penile curvature deformity during erection (manifested as bending, narrowing, hinging, or shortening) and has been associated with significant concern about erection pain or appearance, with potential impact on sexual intercourse, and emotional and relationship distress [1,2]. Based on safety and efficacy demonstrated in the identical phase III, placebo-controlled Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies (IMPRESS) I and II trials, intralesional injection therapy with collagenase Clostridium histolyticum (CCH) was approved by the USA Food and Drug Administration (FDA) for the treatment of adult men with PD with a palpable plaque and curvature deformity of at least 30°at the start of therapy. CCH studies, including a phase IIb study and IMPRESS I and II, showed significant improvement in both penile curvature deformity and PD-specific psychosexual aspects (i.e., Peyronie's Disease Questionnaire PD Symptom Bother domain score), compared with placebo [3,4].CCH is a purified mixture of two microbial collagenases, AUX-I and AUX-II; studies suggest tha...