madman
Super Moderator
Characteristics predictive of response to collagenase clostridium histolyticum for Peyronie’s disease: a review of the literature
Abstract
PurposeTo evaluate characteristics predictive of successful treatment outcomes of Peyronie’s disease (PD) with collagenase clostridium histolyticum (CCH)
Methods CCH is the only FDA-approved medication for treating PD. We reviewed the literature that addresses pre-treatment clinical characteristics that may predict a favorable response to CCH therapy.
Results Despite significant heterogeneity in reporting treatment success, we identified four well-studied characteristics that may be predictive of a favorable response to CCH therapy: baseline penile curvature, baseline IIEF, duration of PD, and presence of calcification. CCH demonstrated a favorable response in those with pre-treatment curvature 30°–60°, longer duration of disease, mild to moderate baseline sexual function, and low calcification within plaques. Of all factors, calcification is emerging as the most significant factor likely because CCH is unable to degrade the calcified plaques. There is difficulty interpreting results because of differences in reporting outcomes. Some studies compared treatment groups to placebo, others reported changes in curvature, while others reported>20% curvature correction as treatment success. Additionally, not all studies reported outcomes after completion of four cycles of CCH, and recent studies utilized a shortened, high dose, modified protocol.
Conclusions The ideal candidate for CCH therapy remains elusive. Based on the available literature, the man with PD who will have the greatest chance of curvature improvement will have curvature between 30° and 60°, longer duration of disease, and IIEF>17, no calcification, and set to receive all four cycles. For a greater understanding of CCH treatment success in PD, prospectively collected registry reporting standardized outcomes are needed.
Introduction
Peyronie’s disease (PD) is an inflammatory condition of the corpus cavernosum leading to penile angulation, painful erections, and impaired sexual function [1]. PD is characterized by an inelastic fibrous plaque in the tunica albuginea, the connective tissue that surrounds the corpus cavernosa [2]. Treatments are either surgical or medical. Surgical treatments for PD are tunical plication, plaque excision, and grafting, or placement of a penile prosthesis (for those with erectile dysfunction) [1]. However, surgery carries a risk of penile shortening, altered penile sensation, and new-onset erectile dysfunction. Only collagenase clostridium histolyticum (CCH) is food and drug administration (FDA) approved for the treatment of PD and is recommended by both the AUA and EAU guidelines in appropriacy selected patients [1]. AUA guidelines also recommend other medical treatments such as oral NSAIDs to treat pain symptoms and label intralesional injections of interferon α-2b and verapamil [1].
Collagenase clostridium histolyticum (CCH) was FDA approved for the treatment of PD in December 2013 after the publication of two large randomized placebo-controlled studies titled Investigation for Maximal Peyronie’s reduction efficacy and safety studies (IMPRESS) [3]. Currently, CCH remains the only FDA-approved medication for the treatment of PD. CCH treatment is time and labor-intensive consisting of multiple injections spaced out over 24 weeks. Unfortunately, meaningful improvements in penile curvature and sexual function are not guaranteed. IMPRESS trial analysis showed a significant mean curvature improvement of − 17.0° and 34%, and a 2.8-point improvement in Peyronie’s disease questionnaire (PDQ) [3].
After the publication of IMPRESS, additional studies confirmed the safety and efficacy of CCH [4]. The IMPRESS trials reported improvements in degrees of curvature, PDQ scores, and percentage curvature change from baseline to assess treatment success [3]. More recently, the authors reported the number or percentage of patients who improve by>20% from baseline as a successful outcome [4–6]. This heterogeneity in outcome reporting creates difficulty in data interpretation and study comparison. However, studies consistently report that not all men who receive CCH improve. Additionally, improvements considered significant do not always result in a return to penetrative sexual activity. Therefore, identifying pre-treatment characteristics predictive of a favorable response to CCH is imperative. In this literature review, we will evaluate pre-treatment patient characteristics that multiple studies found predictive of favorable response to CCH therapy for PD.
*Baseline curvature
*Duration of disease
*Baseline sexual function
*Plaque calcification
*Other factors
Conclusions
The ideal candidate for CCH therapy remains elusive. The majority of studies evaluated are retrospective and were not powered to detect significance in subgroup analysis. Additionally, the definition of successful treatment varies with almost no studies evaluating a return to sexual function as an outcome. Based on the available literature, the man with the greatest chance of curvature improvement has curvature between 30° and 60°, a longer duration of disease, an IIEF>17, and no calcification, and receives all four cycles (Table 2). Nonetheless, curvature and PDQ improvements occurred in men with vastly different characteristics. For a greater understanding, prospectively collected registry studies are needed.
Abstract
PurposeTo evaluate characteristics predictive of successful treatment outcomes of Peyronie’s disease (PD) with collagenase clostridium histolyticum (CCH)
Methods CCH is the only FDA-approved medication for treating PD. We reviewed the literature that addresses pre-treatment clinical characteristics that may predict a favorable response to CCH therapy.
Results Despite significant heterogeneity in reporting treatment success, we identified four well-studied characteristics that may be predictive of a favorable response to CCH therapy: baseline penile curvature, baseline IIEF, duration of PD, and presence of calcification. CCH demonstrated a favorable response in those with pre-treatment curvature 30°–60°, longer duration of disease, mild to moderate baseline sexual function, and low calcification within plaques. Of all factors, calcification is emerging as the most significant factor likely because CCH is unable to degrade the calcified plaques. There is difficulty interpreting results because of differences in reporting outcomes. Some studies compared treatment groups to placebo, others reported changes in curvature, while others reported>20% curvature correction as treatment success. Additionally, not all studies reported outcomes after completion of four cycles of CCH, and recent studies utilized a shortened, high dose, modified protocol.
Conclusions The ideal candidate for CCH therapy remains elusive. Based on the available literature, the man with PD who will have the greatest chance of curvature improvement will have curvature between 30° and 60°, longer duration of disease, and IIEF>17, no calcification, and set to receive all four cycles. For a greater understanding of CCH treatment success in PD, prospectively collected registry reporting standardized outcomes are needed.
Introduction
Peyronie’s disease (PD) is an inflammatory condition of the corpus cavernosum leading to penile angulation, painful erections, and impaired sexual function [1]. PD is characterized by an inelastic fibrous plaque in the tunica albuginea, the connective tissue that surrounds the corpus cavernosa [2]. Treatments are either surgical or medical. Surgical treatments for PD are tunical plication, plaque excision, and grafting, or placement of a penile prosthesis (for those with erectile dysfunction) [1]. However, surgery carries a risk of penile shortening, altered penile sensation, and new-onset erectile dysfunction. Only collagenase clostridium histolyticum (CCH) is food and drug administration (FDA) approved for the treatment of PD and is recommended by both the AUA and EAU guidelines in appropriacy selected patients [1]. AUA guidelines also recommend other medical treatments such as oral NSAIDs to treat pain symptoms and label intralesional injections of interferon α-2b and verapamil [1].
Collagenase clostridium histolyticum (CCH) was FDA approved for the treatment of PD in December 2013 after the publication of two large randomized placebo-controlled studies titled Investigation for Maximal Peyronie’s reduction efficacy and safety studies (IMPRESS) [3]. Currently, CCH remains the only FDA-approved medication for the treatment of PD. CCH treatment is time and labor-intensive consisting of multiple injections spaced out over 24 weeks. Unfortunately, meaningful improvements in penile curvature and sexual function are not guaranteed. IMPRESS trial analysis showed a significant mean curvature improvement of − 17.0° and 34%, and a 2.8-point improvement in Peyronie’s disease questionnaire (PDQ) [3].
After the publication of IMPRESS, additional studies confirmed the safety and efficacy of CCH [4]. The IMPRESS trials reported improvements in degrees of curvature, PDQ scores, and percentage curvature change from baseline to assess treatment success [3]. More recently, the authors reported the number or percentage of patients who improve by>20% from baseline as a successful outcome [4–6]. This heterogeneity in outcome reporting creates difficulty in data interpretation and study comparison. However, studies consistently report that not all men who receive CCH improve. Additionally, improvements considered significant do not always result in a return to penetrative sexual activity. Therefore, identifying pre-treatment characteristics predictive of a favorable response to CCH is imperative. In this literature review, we will evaluate pre-treatment patient characteristics that multiple studies found predictive of favorable response to CCH therapy for PD.
*Baseline curvature
*Duration of disease
*Baseline sexual function
*Plaque calcification
*Other factors
Conclusions
The ideal candidate for CCH therapy remains elusive. The majority of studies evaluated are retrospective and were not powered to detect significance in subgroup analysis. Additionally, the definition of successful treatment varies with almost no studies evaluating a return to sexual function as an outcome. Based on the available literature, the man with the greatest chance of curvature improvement has curvature between 30° and 60°, a longer duration of disease, an IIEF>17, and no calcification, and receives all four cycles (Table 2). Nonetheless, curvature and PDQ improvements occurred in men with vastly different characteristics. For a greater understanding, prospectively collected registry studies are needed.
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