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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 Jan; 12(1):248-58.JS

Abstract

INTRODUCTION

Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration-approved, intralesional treatment for Peyronie's disease (PD).

AIM

The aim of this study was to assess the safety and effectiveness of CCH in the treatment of PD.

METHODS

This phase 3, open-label study enrolled subjects who were CCH-naïve, were enrolled in a previous pharmacokinetic study, or had received placebo in an earlier phase 2 CCH study. Each treatment cycle included two intralesional injections of CCH 0.58 mg, approximately 24-72 hours apart, and plaque modeling 24-72 hours after the second injection of each cycle. The treatment cycle was repeated after 6 weeks for ≤4 treatment cycles.

MAIN OUTCOME MEASURES

The co-primary end points were the mean percent change in penile curvature deformity and the mean improvement in PD bother score (range 0-16) from baseline to week 36.

RESULTS

Of the 347 subjects treated with ≥1 injection, 238 had both a penile curvature measurement and a Peyronie's Disease Questionnaire response at baseline and ≥1 subsequent time point. Mean baseline penile curvature deformity was 53.0° and mean PD symptom bother was 7.3. Statistically significant mean improvements from baseline to week 36 were observed in both penile curvature deformity (34.4% [95% confidence interval {CI}, 31.2%, 37.6%]) and PD symptom bother score (3.3 [95% CI, 2.8, 3.7]). Most adverse events (AEs) were mild or moderate in severity and local to the penis. There were three serious treatment-related AEs, two penile hematomas and one corporal rupture; all resolved with treatment.

CONCLUSIONS

Potentially clinically meaningful and statistically significant improvements in penile curvature deformity and PD symptom bother scores were observed with intralesional injection of CCH compared with baseline in men with PD. CCH was generally well tolerated, with AEs primarily transient and local to injection site. In conjunction with previous studies, the results of this open-label study support the use of CCH in the treatment of PD.

Authors+Show Affiliations

Department of Urology, Rush University Medical Center, Chicago, IL, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25388099

Citation

Levine, Laurence A., et al. "Clinical Safety and Effectiveness of Collagenase Clostridium Histolyticum Injection in Patients With Peyronie's Disease: a Phase 3 Open-label Study." The Journal of Sexual Medicine, vol. 12, no. 1, 2015, pp. 248-58.
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(1):248-58.
Levine, L. A., Cuzin, B., Mark, S., Gelbard, M. K., Jones, N. A., Liu, G., Kaufman, G. J., Tursi, J. P., & Ralph, D. J. (2015). Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. The Journal of Sexual Medicine, 12(1), 248-58. https://doi.org/10.1111/jsm.12731
Levine LA, 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(1):248-58. PubMed PMID: 25388099.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. AU - Levine,Laurence A, AU - Cuzin,Beatrice, AU - Mark,Stephen, AU - Gelbard,Martin K, AU - Jones,Nigel A, AU - Liu,Genzhou, AU - Kaufman,Gregory J, AU - Tursi,James P, AU - Ralph,David J, Y1 - 2014/11/12/ PY - 2014/11/13/entrez PY - 2014/11/13/pubmed PY - 2015/7/15/medline KW - Collagenase Clostridium Histolyticum KW - Efficacy KW - Open-Label KW - Penile Curvature Deformity KW - Peyronie's Disease KW - Peyronie's Disease Symptom Bother SP - 248 EP - 58 JF - The journal of sexual medicine JO - J Sex Med VL - 12 IS - 1 N2 - INTRODUCTION: Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration-approved, intralesional treatment for Peyronie's disease (PD). AIM: The aim of this study was to assess the safety and effectiveness of CCH in the treatment of PD. METHODS: This phase 3, open-label study enrolled subjects who were CCH-naïve, were enrolled in a previous pharmacokinetic study, or had received placebo in an earlier phase 2 CCH study. Each treatment cycle included two intralesional injections of CCH 0.58 mg, approximately 24-72 hours apart, and plaque modeling 24-72 hours after the second injection of each cycle. The treatment cycle was repeated after 6 weeks for ≤4 treatment cycles. MAIN OUTCOME MEASURES: The co-primary end points were the mean percent change in penile curvature deformity and the mean improvement in PD bother score (range 0-16) from baseline to week 36. RESULTS: Of the 347 subjects treated with ≥1 injection, 238 had both a penile curvature measurement and a Peyronie's Disease Questionnaire response at baseline and ≥1 subsequent time point. Mean baseline penile curvature deformity was 53.0° and mean PD symptom bother was 7.3. Statistically significant mean improvements from baseline to week 36 were observed in both penile curvature deformity (34.4% [95% confidence interval {CI}, 31.2%, 37.6%]) and PD symptom bother score (3.3 [95% CI, 2.8, 3.7]). Most adverse events (AEs) were mild or moderate in severity and local to the penis. There were three serious treatment-related AEs, two penile hematomas and one corporal rupture; all resolved with treatment. CONCLUSIONS: Potentially clinically meaningful and statistically significant improvements in penile curvature deformity and PD symptom bother scores were observed with intralesional injection of CCH compared with baseline in men with PD. CCH was generally well tolerated, with AEs primarily transient and local to injection site. In conjunction with previous studies, the results of this open-label study support the use of CCH in the treatment of PD. SN - 1743-6109 UR - https://wwww.unboundmedicine.com/medline/citation/25388099/Clinical_safety_and_effectiveness_of_collagenase_clostridium_histolyticum_injection_in_patients_with_Peyronie's_disease:_a_phase_3_open_label_study_ DB - PRIME DP - Unbound Medicine ER -