Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie’s Disease

No AccessJournal of UrologyAdult Urology1 Jun 2020Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's DiseaseThis article is commented on by the following:Editorial Comment Irwin Goldstein, Larry I. Lipshultz, Michael McLane, Yiqun Hu, Qinfang Xiang, Genzhou Liu, Saji Vijayan, and Martin K. Gelbard Irwin GoldsteinIrwin Goldstein *Correspondence: Alvarado Hospital, 5555 Reservoir Drive, Suite 300, San Diego, California 92120 telephone: 619-265-8865; FAX: 619-265-7696; E-mail Address: [email protected] Alvarado Hospital, San Diego, California , Larry I. LipshultzLarry I. Lipshultz Baylor College of Medicine, Houston, Texas , Michael McLaneMichael McLane Endo Pharmaceuticals Inc., Malvern, Pennsylvania , Yiqun HuYiqun Hu Endo Pharmaceuticals Inc., Malvern, Pennsylvania , Qinfang XiangQinfang Xiang Endo Pharmaceuticals Inc., Malvern, Pennsylvania , Genzhou LiuGenzhou Liu Endo Pharmaceuticals Inc., Malvern, Pennsylvania , Saji VijayanSaji Vijayan Endo Pharmaceuticals Inc., Malvern, Pennsylvania , and Martin K. GelbardMartin K. Gelbard Urology Associates Medical Group, Burbank, California View All Author Informationhttps://doi.org/10.1097/JU.0000000000000743AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We assessed the long-term safety and immunogenicity profile of collagenase clostridium histolyticum and characterized penile curvature deformity over time in patients previously treated for Peyronie's disease. Materials and Methods: This phase 4 study included men who received collagenase clostridium histolyticum in either 12-month, double-blind, placebo controlled clinical trials (IMPRESS I/II), or one of two 9-month open label studies. Eligible patients received no additional collagenase clostridium histolyticum treatment and were followed once yearly for up to 5 years to assess Peyronie's disease clinical symptoms, patient reported outcomes and safety. Results: Of 280 patients enrolled 204 (73%) completed the study. At baseline 247 patients had already experienced a mean±SD penile curvature decrease from 51.8±15.0 to 31.0±16.1 degrees (improvement of 20.9±16.2 degrees or 39.5%). At year 5 in 180 patients, despite no additional treatment, there was an additional 9.1% improvement in mean penile curvature compared with reference data (4.3±13.4 degrees, 95% CI 2.3-6.2, p <0.02). At baseline 183 patients experienced mean Peyronie's Disease Questionnaire bother domain score improvement from 6.5±3.5 to 3.4±3.3. At year 5 there was additional score improvement to 2.4±2.9 (p=0.0003). Adverse events were reported in 17.5% (49) of patients but no adverse events were considered treatment related. No long-term safety issues were identified up to 5 years after treatment. Long-term immunogenicity profiling showed a decreasing trend in the number of anti-AUX-I and anti-AUX-II seropositive cases at years 4 and 5 after collagenase clostridium histolyticum treatment. Conclusions: Most patients treated with collagenase clostridium histolyticum continued to have penile curvature and Peyronie's Disease Questionnaire domain score improvements through year 5 without additional collagenase clostridium histolyticum treatment, and no additional safety signals were identified. References 1. : Understanding the cellular basis and pathophysiology of Peyronie's disease to optimize treatment for erectile dysfunction. Transl Androl Urol 2017; 6: 46. Google Scholar 2. : A review of the epidemiology and treatment of Peyronie's disease. Res Rep Urol 2016; 8: 61. Google Scholar 3. Xiaflex® (collagenase clostridium histolyticum) for injection, for intralesional use prescribing information. Malvern, PA: Endo Pharmaceuticals Inc 2018. Google Scholar 4. : 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; 190: 199. Link, Google Scholar 5. : Changes in the effects of Peyronie's disease after treatment with collagenase clostridium histolyticum: male patients and their female partners. Sex Med 2017; 5: e124. Google Scholar 6. : 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. Google Scholar 7. : Analysis of the clinical safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for adults with Peyronie's disease (PD). BJU Int 2015; 116: 815. Google Scholar 8. : Bother and distress associated with Peyronie's disease: validation of the Peyronie's Disease Questionnaire. J Urol 2013; 190: 627. Link, Google Scholar 9. : The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997; 49: 822. Crossref, Medline, Google Scholar 10. : Recommendations for the primary analysis of continuous endpoints in longitudinal clinical trials. Drug Inform J 2008; 42: 303. Google Scholar 11. : Immunogenicity assessment during the development of protein therapeutics. J Pharm Pharmacol 2018; 70: 584. Google Scholar 12. : The management of Peyronie's disease: evidence-based 2010 guidelines. J Sex Med 2010; 7: 2359. Google Scholar 13. : 2018 Canadian Urological Association guideline for Peyronie's disease and congenital penile curvature. Can Urol Assoc J 2018; 12: E197. Google Scholar 14. : Risk factors for emotional and relationship problems in Peyronie's disease. J Sex Med 2008; 5: 2179. Google Scholar 15. : The chronology of depression and distress in men with Peyronie's disease. J Sex Med 2008; 5: 1985. Google Scholar 16. : Impact of Peyronie's disease on sexual and psychosocial functioning: qualitative findings in patients and controls. J Sex Med 2008; 5: 1977. Google Scholar Supported by Endo Pharmaceuticals Inc., Malvern, Pennsylvania. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Editor's Note: This article is the fifth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 1222 and 1223. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited bySeftel A (2020) Re: The Use of Penile Computed Tomography Cavernosogram in the Evaluation of Peyronie's Disease: A Pilot StudyJournal of Urology, VOL. 204, NO. 4, (861-861), Online publication date: 1-Oct-2020.Seftel A (2020) Re: Multicenter Experience Using Collagen Fleece for Plaque Incision with Grafting to Correct Residual Curvature at the Time of Inflatable Penile Prosthesis Placement in Patients with Peyronie's DiseaseJournal of Urology, VOL. 204, NO. 3, (599-599), Online publication date: 1-Sep-2020.Smith J (2020) This Month in Adult UrologyJournal of Urology, VOL. 203, NO. 6, (1033-1034), Online publication date: 1-Jun-2020.Related articlesJournal of Urology10 Mar 2020Editorial Comment Volume 203Issue 6June 2020Page: 1191-1197 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.Keywordssafetymicrobial collagenasepenile indurationtreatment outcomeAcknowledgementsTechnical editorial and medical writing assistance was provided by Mary Beth Moncrief and Julie B. Stimmel, Synchrony Medical Communications, LLC, West Chester, Pennsylvania. Funding for this assistance was provided by Endo Pharmaceuticals Inc.MetricsAuthor Information Irwin Goldstein Alvarado Hospital, San Diego, California *Correspondence: Alvarado Hospital, 5555 Reservoir Drive, Suite 300, San Diego, California 92120 telephone: 619-265-8865; FAX: 619-265-7696; E-mail Address: [email protected] Financial interest and/or other relationship with Coloplast, Emotional Brain, Nuelle, Pfizer, Sprout, Strategic Science & Technologies, TestoRx, Allergan, Amphastar, Dornier MedTech, Endo Pharmaceuticals Inc., Evidera, NERI, Palatin, Plethora, Shionogi and TGI. More articles by this author Larry I. Lipshultz Baylor College of Medicine, Houston, Texas Financial interest and/or other relationship with AbbVie, Aytu BioScience, Endo Pharmaceuticals Inc., Lipocine and American Medical Systems. More articles by this author Michael McLane Endo Pharmaceuticals Inc., Malvern, Pennsylvania Financial interest and/or other relationship with Endo Pharmaceuticals Inc. More articles by this author Yiqun Hu Endo Pharmaceuticals Inc., Malvern, Pennsylvania Financial interest and/or other relationship with Endo Pharmaceuticals Inc. More articles by this author Qinfang Xiang Endo Pharmaceuticals Inc., Malvern, Pennsylvania Financial interest and/or other relationship with Endo Pharmaceuticals Inc. More articles by this author Genzhou Liu Endo Pharmaceuticals Inc., Malvern, Pennsylvania Financial interest and/or other relationship with Endo Pharmaceuticals Inc. More articles by this author Saji Vijayan Endo Pharmaceuticals Inc., Malvern, Pennsylvania Financial interest and/or other relationship with Endo Pharmaceuticals Inc. More articles by this author Martin K. Gelbard Urology Associates Medical Group, Burbank, California Financial interest and/or other relationship with Biospecifics Technologies Corporation and Endo Pharmaceuticals Inc. More articles by this author Expand All Supported by Endo Pharmaceuticals Inc., Malvern, Pennsylvania. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Editor's Note: This article is the fifth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 1222 and 1223. Advertisement PDF downloadLoading ...