A state-of-art review on collagenase Clostridium Histolyticum and Peyronie’s disease: drug profile, clinical evidence and safety outcomes

ABSTRACT

Introduction: Collagenase clostridium histolyticum (CCH) is the first and only licensed medical treatment for men with Peyronie’s disease (PD). Published literature shows intralesional CCH injection as an effective and safe minimally invasive treatment in a specific subgroup of PD patients.

Areas covered: The authors discuss pharmacodynamics and pharmacokinetics as well as clinical outcomes and safety profile from major CCH studies in PD. All relevant CCH studies published in PubMed and EMBASE databases up to June 2019 were included.

Expert opinion: Given the variability in treatment schedule and drug access coupled with the potential need for further treatment, strict patient selection and the use of adjunctive strategies are key determinants to maximize clinical efficacy of intralesional CCH. Furthermore, longer-term follow-up data on the clinical outcomes, safety and durability of CCH in larger multi-center studies and post-marketing surveillance data are necessary to provide a comparison to other standard PD treatment options.

KEYWORDS:

• Clostridium histolyticum
• Peyronie’s disease
• intralesional therapy
• clinical outcomes
• safety

Article Highlights

• Collagenase Clostridium Histolyticum (CCH) has emerged as an effective, well-tolerated and safe therapeutic option to treat men with Peyronie’s disease (PD).

• The strict inclusion and exclusion criteria currently in place for CCH use based on IMPRESS I and II studies potentially limit its clinical utility and general application in men with ventral curvature, lateral indentation, hourglass deformity or calcified penile plaque.

• The positive change in penile curvature and plaque size with CCH therapy is augmented with manual penile modelling performed following each treatment cycles.

• Reported adverse events are typically mild to moderate, usually self-limiting and should resolve spontaneously with conservative management.

• CCH use is currently only available in North America after it was withdrawn from Europe and Australasia markets, not because of safety or efficacy concern, rather due to commercial reasons.

• Adequate patient counselling regarding CCH treatment expectation remains pivotal to ensure high patient satisfaction and treatment continuation.

This box summarizes key points contained in the article.

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper is not funded.