PMID- 25388099 OWN - NLM STAT- MEDLINE DCOM- 20150713 LR - 20220310 IS - 1743-6109 (Electronic) IS - 1743-6095 (Linking) VI - 12 IP - 1 DP - 2015 Jan TI - Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. PG - 248-58 LID - 10.1111/jsm.12731 [doi] AB - 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-naive, 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 /=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 degrees 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. CI - (c) 2014 International Society for Sexual Medicine. FAU - Levine, Laurence A AU - Levine LA AD - Department of Urology, Rush University Medical Center, Chicago, IL, USA. FAU - Cuzin, Beatrice AU - Cuzin B FAU - Mark, Stephen AU - Mark S FAU - Gelbard, Martin K AU - Gelbard MK FAU - Jones, Nigel A AU - Jones NA FAU - Liu, Genzhou AU - Liu G FAU - Kaufman, Gregory J AU - Kaufman GJ FAU - Tursi, James P AU - Tursi JP FAU - Ralph, David J AU - Ralph DJ LA - eng SI - ClinicalTrials.gov/NCT01243411 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20141112 PL - Netherlands TA - J Sex Med JT - The journal of sexual medicine JID - 101230693 RN - EC 3.4.24.3 (Microbial Collagenase) SB - IM MH - Adult MH - Clostridium histolyticum/enzymology MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Follow-Up Studies MH - Hematoma/chemically induced MH - Humans MH - Injections, Intralesional/adverse effects MH - Male MH - Microbial Collagenase/*administration & dosage/*adverse effects/pharmacokinetics MH - Middle Aged MH - Patient Satisfaction MH - Penile Induration/*drug therapy/physiopathology/psychology MH - Penis/*drug effects/injuries/*pathology MH - Rupture/etiology MH - Surveys and Questionnaires MH - Treatment Outcome OTO - NOTNLM OT - Collagenase Clostridium Histolyticum OT - Efficacy OT - Open-Label OT - Penile Curvature Deformity OT - Peyronie's Disease OT - Peyronie's Disease Symptom Bother EDAT- 2014/11/13 06:00 MHDA- 2015/07/15 06:00 CRDT- 2014/11/13 06:00 PHST- 2014/11/13 06:00 [entrez] PHST- 2014/11/13 06:00 [pubmed] PHST- 2015/07/15 06:00 [medline] AID - S1743-6095(15)30881-X [pii] AID - 10.1111/jsm.12731 [doi] PST - ppublish SO - J Sex Med. 2015 Jan;12(1):248-58. doi: 10.1111/jsm.12731. Epub 2014 Nov 12.