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.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1097/JU.0000000000000743 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Formulation development of highly stable collagenase-containing hydrogels for wound healing.
J Pharm Sci
January 2025
Third World Center for Science and Technology, H.E.J. Research Institute of Chemistry, International Center for Chemical and Biological Sciences, University of Karachi, Karachi 75270, Pakistan. Electronic address:
Collagenases are enzymes that break down collagen and are used in wound healing and treating various disorders. Currently, collagenase is commercially available in only ointment and injectable forms and is sensitive to various environmental factors. In the present study, different hydrogel formulations of collagenase have been prepared at pH 6.
View Article and Find Full Text PDFThe case of a woman with bilateral Dupuytren's contractures who developed CRPS-1 after fasciectomy with no relapse on subsequent collagenase clostridium histolyticum injection and manipulation of the other hand: Considerations for implementing a Budapest criteria checklist and assessing vasomotor instability by measuring differences in skin temperature.
J Hand Ther
January 2025
Saint Joseph, MI, USA. Electronic address:
Background: For patients who experience atypical neurogenic pain thought to be complex regional pain syndrome (CRPS) after Dupuytren's fasciectomy early recognition has been reported to improve outcomes. Furthermore, given the progressive nature of Dupuytren's, individuals with a history of CRPS have been "at risk" for further surgical intervention.
Purpose: To familiarize therapists with a Budapest criteria (BC) checklist for early diagnosis of CRPS, describe how tracking sudomotor/vasomotor signs alongside differences in skin temperature were used to monitor vasomotor instability and intervention effectiveness for a patient with atypical pain after fasciectomy and to detail management of the same patient with a CRPS history who had collagenase clostridium histolyticum (CCH) injection of her other hand without exacerbating CRPS.
Purpose Of Review: Peyronie's disease characterizes a condition in which there is angular curvature of the penis. We know that the most patients with Peyronie's disease will not have spontaneous resolution of their penile curvature. As such, patients who desire treatment can elect for either surgical or nonsurgical therapy.
View Article and Find Full Text PDFModeling, synthesis and in vitro testing of peptides based on unusual amino acids as potential antibacterial agents.
Biomed Khim
December 2024
Scientific and Production Center "Armbiotechnology" NAS RA, Yerevan, Armenia; Yerevan State University, Yerevan, Armenia.
Currently non-protein amino acids and synthetic peptides are widely used as blocks in drug design. Many proteases are of great interest for pharmacology due to their key role in various pathologies. Bacterial collagenase (EC 3.
View Article and Find Full Text PDFAn illustrated description of a modified collagenase Clostridium histolyticum protocol for Peyronie's disease.
J Sex Med
December 2024
Department of Life Sciences, Brigham Young University, Provo, UT, 84602, United States.
Background: Our team recently published outcomes of a novel technique for the administration of Collagenase Clostridium histolyticum (CCH), which resulted in improved curvature outcomes and reduced number of CCH injections required.
Aim: To provide a detailed and illustrated description of our CCH-administration technique.
Methods: A descriptive summary is provided of the technique, including drug administration, protocol modifications, and post-treatment protocols.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!