Peyronie Disease Responds to New Medical Treatment

Joe Barber Jr, PhD

May 30, 2012

May 30, 2012 — Collagenase Clostridium histolyticum (CCh) alleviates many symptoms of Peyronie disease, according to the findings of a phase 2b randomized, double-blind, placebo-controlled trial.

Martin Gelbard, MD, from Urology Associates Medical Group in Burbank, California, and colleagues published their findings in the June 2012 issue of the Journal of Urology.

The authors note that there is a need for additional nonsurgical treatments for Peyronie disease. "Surgery is the standard of care for moderate to severe cases of [Peyronie disease] unresponsive to medical therapy," they write. "However, surgery is only recommended for patients with sexual dysfunction in the stable phase of disease since complications include penile shortening, sensory change, recurrent penile curvature and [erectile dysfunction]."

To assess the efficacy of CCh, the authors recruited 147 patients from 12 American sites. They stratified patients by degree of penile curvature (30 - 60° or >60°) and randomly assigned them for treatment with either CCh or placebo (3:1 randomization), with or without penile plaque modeling (1:1 randomization). CCh treatment improved curvature by 29.7% (mean change, −16.3° ± 14.65°) compared with an improvement of 11% (mean change, −5.4 ± 13.8°) in the placebo group (P = .001).

For each treatment cycle, patients received 2 injections of CCh (0.58 mg or 10,000 U) or placebo, separated by 24 to 72 hours, and treatment was repeated after 6 weeks for a maximum of 6 treatment cycles. The authors measured penile length and curvature using calipers and assessed the effects of Peyronie disease on patient quality of life and penile function, using the Peyronie disease patient-reported outcome (PD-PRO) and International Index of Erectile Function (IIEF) questionnaires, respectively.

Among patients who underwent penile plaque modeling, patients treated with CCh exhibited a 32.4% improvement in penile curvature (mean change, − 17.5° ± 15.3°) compared with a 2.5% worsening (mean change, 0.6° ± 13.2°) in the placebo group (P < .001). Conversely, among nonmodeled patients, no difference was observed in the change in penile curvature between the CCh and placebo groups (27.1% vs 27.9%, respectively).

Among the modeled patients, those treated with CCh had a significantly higher mean improvement in the PD-PRO symptom bother domain score compared with placebo (mean change, −3.6° vs −0.1°, respectively; P = .004), whereas no change was observed among nonmodeled patients (−1.5° vs −1.5°, respectively). Moreover, among the modeled patients, CCh treatment was associated with a significant mean improvement in the IIEF overall sexual satisfaction score compared with placebo (P = .04).

Adverse events were significantly more common among CCh-treated patients, including bruising (P < .001), edema (P < .001), pain (P < .001), contusion (P = .07), penile pain (P = .07), and penile edema (P = .07). However, most adverse events were mild to moderate in severity. The limitations of the study included the use of a fixed prostaglandin E1 dose to induce erection before measurements and the learning curve of the investigators regarding the injection technique.

The authors indicate that additional studies are underway to better clarify the efficacy of this treatment. "[The r]esults suggest that CCh should be considered a viable treatment option" for patients with Peyronie disease, they write. "Placebo controlled, phase 3 studies of [Peyronie disease]...are currently ongoing to provide additional safety and efficacy information."

John P. Mulhall, MD, from the Memorial Sloan-Kettering Cancer Center in New York City, indicated that this agent may soon be available for clinical use. "This early phase study demonstrates promising results for this intralesional agent," Dr. Mulhall told Medscape Medical News by email. "Phase III trials with 600 men enrolled will be completed soon, and it is hoped that the data will be presented to the [US Food and Drug Administration] in 2012 with hopes for an approval in 2013."

Dr. Gelbard has a financial interest and/or other relationship with Auxilium and Biospecifics. One coauthor has a financial interest and/or other relationship with Allergan, Auxilium, American Medical Systems, and Repros Therapeutics. Three coauthors are employed by Auxilium. One coauthor has a financial interest and/or other relationship with Auxilium, Coloplast, Lilly, Astellas, Pfizer, and American Medical Systems. Dr. Mulhall has disclosed no relevant financial relationships.

J Urol. 2012;187:2268-2274. Abstract

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