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Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's Disease.
J Urol. 2020 06; 203(6):1191-1197.JU

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.

Authors+Show Affiliations

Alvarado Hospital, San Diego, California.Baylor College of Medicine, Houston, Texas.Endo Pharmaceuticals Inc., Malvern, Pennsylvania.Endo Pharmaceuticals Inc., Malvern, Pennsylvania.Endo Pharmaceuticals Inc., Malvern, Pennsylvania.Endo Pharmaceuticals Inc., Malvern, Pennsylvania.Endo Pharmaceuticals Inc., Malvern, Pennsylvania.Urology Associates Medical Group, Burbank, California.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31922462

Citation

Goldstein, Irwin, et al. "Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated With Collagenase Clostridium Histolyticum for Peyronie's Disease." The Journal of Urology, vol. 203, no. 6, 2020, pp. 1191-1197.
Goldstein I, Lipshultz LI, McLane M, et al. Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's Disease. J Urol. 2020;203(6):1191-1197.
Goldstein, I., Lipshultz, L. I., McLane, M., Hu, Y., Xiang, Q., Liu, G., Vijayan, S., & Gelbard, M. K. (2020). Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's Disease. The Journal of Urology, 203(6), 1191-1197. https://doi.org/10.1097/JU.0000000000000743
Goldstein I, et al. Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated With Collagenase Clostridium Histolyticum for Peyronie's Disease. J Urol. 2020;203(6):1191-1197. PubMed PMID: 31922462.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie's Disease. AU - Goldstein,Irwin, AU - Lipshultz,Larry I, AU - McLane,Michael, AU - Hu,Yiqun, AU - Xiang,Qinfang, AU - Liu,Genzhou, AU - Vijayan,Saji, AU - Gelbard,Martin K, Y1 - 2020/01/10/ PY - 2020/1/11/pubmed PY - 2020/8/25/medline PY - 2020/1/11/entrez KW - microbial collagenase KW - penile induration KW - safety KW - treatment outcome SP - 1191 EP - 1197 JF - The Journal of urology JO - J Urol VL - 203 IS - 6 N2 - 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. SN - 1527-3792 UR - https://wwww.unboundmedicine.com/medline/citation/31922462/Long_Term_Safety_and_Curvature_Deformity_Characterization_in_Patients_Previously_Treated_with_Collagenase_clostridium_Histolyticum_for_Peyronie's_Disease_ DB - PRIME DP - Unbound Medicine ER -