Peyronie’s treatment shows efficacy in phase III studies

April 23, 2014

Intralesional injection of collagenase clostridium histolyticum (CCH [XIAFLEX]) improves the physical and psychological aspects of Peyronie’s disease in men regardless of erectile dysfunction severity and whether they have a history of prior treatment or prostatectomy, according to a recent study.

Stockholm, Sweden-Intralesional injection of collagenase clostridium histolyticum (CCH [XIAFLEX]) improves the physical and psychological aspects of Peyronie’s disease (PD) in men regardless of erectile dysfunction severity and whether they have a history of prior treatment or prostatectomy, according to a recent study.

To gain perspective on whether outcomes of treatment with CCH were affected by certain clinical history factors, a variety of subgroup analyses were undertaken using data from 401 men treated with CCH in two phase III clinical studies. Within the CCH-treated cohort, 227 men had prior PD treatment (56.6%), 11 had a history of prostatectomy (2.7%), and based on their International Index of Erectile Function score, 16 men had no sexual activity (4.0%), 67 men had low sexual activity (16.7%), and 314 were considered to have high erectile function (78.3%).

Dr. Burnett“The findings of these post hoc analyses are not surprising considering treatment with CCH addresses the scarring that is the underlying cause of the curvature in PD,” said Arthur L. Burnett, II, MD, MBA, who was a phase III study investigator and is professor of urology, cellular and molecular medicine at Johns Hopkins Medicine, Baltimore.

“The results make the point that men with PD should not be precluded from being offered this therapy on the basis of preconceptions that they may be less likely to respond because they had received prior treatment for PD, were experiencing severe erectile dysfunction, or were post-prostatectomy,” added Dr. Burnett of the findings, which were presented at the European Association of Urology annual congress in Stockholm, Sweden.

The two phase III clinical studies investigating the efficacy, safety, and tolerability of CCH, known as IMPRESS I and II (Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies), enrolled men aged 18 years and older with penile curvature ≥30° in the dorsal, lateral, or dorsal/lateral plane. They were randomized to double-blind treatment with CCH or saline. Patients received up to four treatment cycles separated by intervals of approximately 6 weeks. In each treatment cycle, patients received two injections, given 24 to 72 hours apart, followed by modeling of the plaque to stretch or elongate it.

Change from baseline to week 52 in percentage of penile curvature deformity and Peyronie’s Disease Questionnaire PD Symptom Bother score were assessed as co-primary endpoints.

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A meta-analysis of pooled data showed that CCH-treated men achieved a mean 34% improvement in penile curvature and a mean 2.8-point improvement in their PD symptom bother score; both results were significantly superior to control.

In the subgroup analyses, penile curvature deformity improved by a mean of 34.8% in men with prior PD treatment and 33.0% in those who were PD treatment-naïve; mean improvement in PD symptom bother score in these two subgroups was 2.6 and 3.1, respectively.

The mean improvement in penile curvature deformity for men with no sexual activity, low erectile function, and high erectile function was 28.0%, 27.6%, and 35.6%, respectively; mean improvement in PD symptom bother score within these three subgroups was 2.9, 3.5, and 2.7, respectively.

Treatment efficacious in post-RP patients

Men with no history of prostatectomy had a mean 34% improvement in penile curvature deformity and a mean improvement of 2.8 in their PD Symptom Bother score. Their counterparts who had undergone prostatectomy had a mean 31.4% improvement in penile curvature deformity and a mean change in PD symptom bother score of 2.5.

“It has been shown that microscopic and even macroscopic scarring of the penile sheath can develop with dormancy of the penis following prostatectomy. Although the number of men in the post-prostatectomy subgroup in these studies was small, the data suggest that men who have undergone prostatectomy should still be considered eligible to try CCH therapy,” said Dr. Burnett.

He added that while some men may cringe at the idea of receiving a needle injection into the penis, based on his first-hand experience as a clinical trial investigator, the procedure was well tolerated and was not associated with significant major complications.

Nevertheless, CCH for treatment of PD is available only through a restricted program under a Risk Evaluation and Mitigation Strategy that requires health care professionals and their facilities to be certified and that the professionals complete training in CCH administration.

Auxilium Pharmaceuticals and Swedish Orphan Biovitrum AB provided support for the study.UT

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