CCH treatment found safe, efficacious for acute-phase Peyronie disease

Collagenase clostridium histolyticum (CCH; Xiaflex) is not indicated to treat acute-phase Peyronie disease (PD), but it should be, according to a study published in Urology.¹

Researchers have reported that CCH reduces penile curvature by an average of 35% in men with stable-phase PD. However, two large, randomized, phase 3 studies did not include patients in the acute phase of the disease, often defined as patients who have had PD for fewer than 12 months.

Urologists typically do not treat PD aggressively, including surgically, for 1 year, according to the study’s senior author, Wayne J.G. Hellstrom, MD, professor of urology and chief of andrology at Tulane University School of Medicine in New Orleans, Louisiana.

“The original Xiaflex collagenase studies evaluated patients after 12 months and found there was a substantial improvement in these patients. What was different about this study is we studied patients with these intralesional injections before the 12-month period of time and what we found was there were similar improvements in penile curvature. There was no increase in side effects from treating patients earlier,” Hellstrom said. “It makes sense to offer Xiaflex to patients in the early stages of PD because afflicted men are really psychologically affected and can benefit.”

In fact, in “Peyronie’s Disease: American Urological Association Guideline,” researchers reported that many men with penile curvature experience emotional distress, depressive symptoms, and relationship difficulties.² More than half of men report that the stress of PD negatively impacts their relationships. Many have said their concerns about how their penis looks harms their self-image and sexual satisfaction. Many also suffer in isolation, finding it difficult to talk with their doctors and partners about the condition.

Hellstrom and colleagues at 5 US institutions retrospectively collected data from 918 consecutive PD patients treated with CCH between April 2014 and March 2018. Of those patients, 134 (14.6%) had acute-phase disease with PD duration of up to 6 months, and 784 (85.4%) had longer-term stable disease.

The investigators found that treating PD in the early acute-phase with CCH is as safe and effective as treating it in the stable, chronic phase. Final change in curvature in the acute group was 13.5 degrees versus 15.6 degrees in the stable group. They found a similar frequency between groups of patients with at least 20% curvature improvement and low proportions of men needing eventual surgical correction for residual curvature.

Overall, 10.1% of the men studied had moderate-to-severe complications, including penile hematomas, corporal rupture, and severe penile swelling. Of patients in the acute and stable groups, respectively, 16 (11.9%) and 77 (9.8%) experienced treatment-related adverse events. The difference was not statistically significant, according to the authors.

Men with any kind of curvature greater than 30 degrees are candidates for early intralesional CCH therapy.

However, “if patients have calcification of the plaque that prevents insertion of a needle, or if they’re on anticoagulants where they would be more likely to bleed, they probably would not be the best candidates for this therapy,” Hellstrom said. “The main point is that while we generally don’t perform surgery for PD in the first year, it makes sense to treat these patients earlier with intralesional collagenase clostridium histolyticum.”

Among the study’s limitations is the authors’ definition of acute-phase PD as duration of 6 months or less; that is not the only widely used definition for the condition. The American Urological Association defines it as PD characterized by dynamic and changing symptoms.

More studies are needed to confirm these results, the authors wrote.

Disclosure: Dr Hellstrom is a speaker and consultant for Endo.

References

1. Nguyen HMT, Yousif A, Chung A, et al. Safety and efficacy of collagenase clostridium histolyticum in the treatment of acute phase Peyronie’s disease: a multi-institutional analysis. Urology. Published online August 7, 2020. doi:10.1016/j.urology.2020.07.048

2. Nehra A, Alterowitz R, Culkin DJ, et al; American Urological Association Education and Research, Inc. Peyronie’s disease: AUA guideline. J Urol. 2015;194(3):745-753. doi:10.1016/j.juro.2015.05.098