Baseline Characteristics from an Ongoing Phase 3 Study of Collagenase Clostridium Histolyticum in Patients with Peyronie's Disease

Abstract

Introduction Peyronie's disease (PD) is a localized penile collagen disorder of the tunica albuginea associated with significant physical deformity and psychological impairment. Current understanding of pretreatment characteristics in patients with chronic PD is limited by small samples, varied quality of assessments, and the lack of a PD-specific, validated measure of the psychosexual impact of PD. Aims Reporting baseline demographic and disease characteristics of the large multinational cohort of subjects with chronic PD who participated in the collagenase clostridium histolyticum (CCH, an investigational intralesional injection and minimally invasive intervention) phase 3 clinical study program. Findings from well-defined assessments, including the Peyronie's Disease Questionnaire (PDQ), the first validated PD-specific patient-reported measure of psychosexual impact, are reported. Methods Subjects included men ≥18 years old with PD symptoms ≥12 months and penile deformity between 30° and 90°. Analysis data included demographics, disease history, and psychosexual impact. Main Outcome Measures Penile deformity, disease symptoms, the International Index of Erectile Function, and the PDQ were assessed. Results Eight hundred thirty-two subjects were enrolled from 64 sites across the United States and Australia. The mean age was 57.7 years; mean PD duration was 4.1 years. The majority of subjects had penile deformity ≤60° (77.3%); mean penile deformity was 50.5°. Subjects reported having intercourse a mean of 10.2 times in the previous 3 months, 70.8% reported difficulty in performing vaginal intercourse, and 80.4% reported less frequent vaginal intercourse. Approximately 71.5% of subjects with severe (>60°) and 58.1% of subjects with mild/moderate (≤60°) penile deformity were “very bothered” or “extremely bothered” upon last look at their erect penis (P = 0.0041), as measured by the PDQ. Conclusions These data add to the body of knowledge regarding the clinical impact of chronic phase PD, including the PD-specific patient-reported psychosexual symptoms, using a large multinational chronic PD cohort in the CCH phase 3 clinical program. Gelbard M, Hellstrom WJG, McMahon CG, Levine LA, Smith T, Tursi J, Kaufman G, and Goldstein I. Baseline characteristics from an ongoing phase 3 study of collagenase clostridium histolyticum in patients with Peyronie's disease. J Sex Med 2013;10:2822–2831.

Collagenase Clostridium Histolyticum: A Review in Peyronie’s Disease

“…Men aged C18 years who had PD for C12 months, with a penile curvature of C30°in the dorsal, lateral or dorsal/lateral plane during stable disease were eligible for the studies; patients with a penile curvature of \30°or [90°, or with ventral curvature from any cause were excluded [21]. At baseline, across both studies, the mean age of the patients was 57.7 years, the mean duration of disease was 4.1 years, 49.6 % of patients had a history of erectile dysfunction, and 77.3 % of patients had a penile deformity of B60° [22].…”

“…In terms of PD symptom bother scores, significant (p \ 0.05) reductions with CCH at week 52 were seen in patients with penile curvature deformity of 30°-60°, disease duration of[4 years, no calcification, and no sexual activity or high erectile function [27]. BL baseline, CCH Collagenase Clostridium Histolyticum, mITT modified intent-to-treat (pts with a penile curvature abnormality measurement and a PDQ response at BL and C1 subsequent time point), PD Peyronie's disease, PDQ PD questionnaire, PL placebo * p \ 0.05, ** p \ 0.01, *** p \ 0.0001 vs. PL a Defined as the distance from the corona to the maximum point of curvature after injecting prostaglandin E1 or trimix into a corpus cavernosum to induce erection b PD symptom bother domain consisted of four scored items (erection pain, erection appearance, and the impact of PD on intercourse and on the frequency of intercourse; score range 0-16) and two yes/no questions that were not scored or counted as distinct items [22,25] c Coprimary endpoints Another post hoc analysis showed that in CCH-treated subjects whose final penile curvature deformity was less than or equal to that of the lowest 50 % of penile curvature deformity at baseline (i.e. a penile curvature deformity of B45°at the end of the study; n = 314), CCH treatment was associated with clinically meaningful improvements in curvature deformity (i.e.…”

Collagenase <em>Clostridium histolyticum</em> in the treatment of Peyronie&rsquo;s disease: patient selection and perspectives

“…Statistical significance is indicated by bold P -values. Data from several studies 8,11,22,25,30–32,34,35,38–44

Abbreviations: CCH, collagenase Clostridium histolyticum ; PD, Peyronie’s disease; IMPRESS, Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies; AE, adverse effect; PDQ, Peyronie’s Disease Questionnaire; IIEF, International Index of Erectile Function; ILI, intralesional injection; FSP, female sexual partner; n/a, not available.

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“…Statistical significance is indicated by bold P -values. Data from several studies 8,11,22,25,30–32,34,35,38–44…”

Nonsurgical treatment options in Peyronie’s Disease: 2016 update

“…Since serious adverse events did occur in six patients including three cases of corporeal ruptures requiring surgical repair and three penile hematomas, it has been recommended that patients should avoid intercourse for at least 2 weeks after intralesional CCh injection. [36,37] Since the IMPRESS trials, the safety and efficacy of CCh has been supported by a phase-3 open-label trial and it is currently approved by FDA for the intralesional use for the treatment of PD.…”