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Editorial Comment on ‘Limited success with Clostridium Collagenase Histolyticum following FDA approval for the treatment of Peyronie’s disease’

International Journal of Impotence Research volume 31, pages 54–55 (2019)Cite this article

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In December 2013, Collagenase Clostridium Histolyticum (CCH) was approved by the FDA for the treatment of penile curvature associated with Peyronie’s disease (PD). This approval was mainly based on 2 large double-blind, randomized, placebo-controlled phase 3 studies, the IMPRESS I and II studies, which included 401 treated patients and showed a statistically significant reduction in penile curvature following CCH treatment [1]. At that time, further available evidence to support CCH use was limited to only 4 phase 1 and 2 studies, conducted over 27 years (1985–2012) which altogether included only 225 subjects [2]. After CCH FDA approval, the only large-scale study supporting the use of CCH was published by Levine et al. in 2015, a phase 3 study which included 347 subjects (306 subjects completed the study and 238 were available for curvature improvement analysis) [3]. This study closely reproduced the results of the IMPRESS I and II studies—statistically significant reduction in penile curvature. At first glance, this body of evidence should be sufficient for the practicing urologist to recommend and administer CCH treatment to patients with characteristics that are similar to those of the studied patients’ populations in the above-mentioned phase 3 studies. Apparently, it may seem that there is no need for an additional small retrospective, uncontrolled study, such as the present study by Tsambarlis et al. [4].

However, the present study sheds new light on treating penile curvature with CCH. This real-life study retrospectively reviews the clinical experience of one large highly-specialized referral center. In this large center, only 45 patients were treated with CCH over a 3.5 years period and included in the study, although it is claimed that CCH treatment has been widely adopted since its FDA approval in 2013 [5]. The findings of the present study are quite surprising: overall a minimal and statistically insignificant curvature reduction, and ultimately high rate of dissatisfaction. Only 20 subjects complied with the treatment and completed full 4 cycles of the CCH treatment protocol. Only this group that fully completed the protocol had statistically significant curvature improvement, the mean of which was only about 10°. Interestingly, Abdel Raheem et al. [6] suggested a shortened treatment protocol, aimed at easing the burden on both doctors and patients and improve compliance, with favorable results. The authors of the present study also mention the relatively high rate of tunical rupture, a serious well-described adverse event related to CCH, in their series. A much higher rate of tunical rupture compared with the rate reported in the large phase 3 studies has also been suggested by Yafi et al. [7].

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References

  1. Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, et al. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013. https://doi.org/10.1016/j.juro.2013.01.087

  2. Gabrielson AT, Spitz JT, Hellstrom WJG. Collagenase Clostridium Histolyticum in the treatment of urologic disease: current and future impact. Sex Med Rev. 2018;6:143–56.

    Article  Google Scholar 

  3. Levine LA, Cuzin B, Mark S. et al. Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie’s disease: a phase 3 open-label study. J Sex Med. 2015;12:248–58.

    Article  Google Scholar 

  4. Tsambarlis PN, Yong R, Levine LA. Limited success with clostridium collagenase histolyticum following FDA approval for the treatment of Peyronie's disease. Int J Impot Res. 2018 Aug 17. doi: 10.1038/s41443-018-0063-1. [Epub ahead of print] PubMed PMID: 30120383.

  5. Capoccia E, Levine LA. Contemporary review of Peyronie’s disease treatment. Curr Urol Rep. 2018;19:51

    Article  Google Scholar 

  6. Abdel Raheem A, Capece M, Kalejaiye O. et al. Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie’s disease using a new modified shortened protocol. BJU Int. 2017;120:717–23.

    Article  CAS  Google Scholar 

  7. Yafi FA, Anaissie J, Zurawin J, Sikka SC, Hellstrom WJG. Results of SMSNA Survey regarding complications following intralesional injection therapy with collagenase clostridium histolyticum for Peyronie’s disease. J Sex Med. 2016;13:684–9.

    Article  Google Scholar 

  8. Cordon BH, Hofer MD, Hutchinson RC, Broderick GA, Lotan Y, Morey AF. Superior Cost Effectiveness of Penile Plication vs Intralesional Collagenase Injection for Treatment of Peyronie's Disease Deformities. Urology Practice. 2017 Mar 1;4(2):118-125. Available from, https://doi.org/10.1016/j.urpr.2016.04.005

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  1. Rambam Health Care Campus, Nuero-Urology Unit, Haifa, Israel

    Raanan Tal

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  1. Raanan Tal
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Correspondence to Raanan Tal.

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Tal, R. Editorial Comment on ‘Limited success with Clostridium Collagenase Histolyticum following FDA approval for the treatment of Peyronie’s disease’. Int J Impot Res 31, 54–55 (2019). https://doi.org/10.1038/s41443-018-0086-7

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