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

Gelbard, Martin K.; Goldstein, Irwin; Hellstrom, Wayne J.G.; McMahon, Chris G.; Smith, Ted; Tursi, James P.; Jones, Nigel; Kaufman, Gregory J.; Carson, Culley C.

doi:10.1016/j.juro.2013.01.087

Cited by 376 publications

(421 citation statements)

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“…Most patients in Study 3 received three injections of CCH. This is consistent with studies of CCH for Dupuytren's contracture [1,5,10] and in clinical trials of CCH for Peyronie's disease using multiple injections [3]. Compared with other clinical studies of conservative treatment of adhesive capsulitis [2,6,8,9,11], CCH injections in Study 3 allowed patients to achieve improved ROM, functional status, and pain relief in a shorter time.…”

Section: Discussionsupporting

confidence: 83%

CORR® ORS Richard A. Brand Award: Clinical Trials of a New Treatment Method for Adhesive Capsulitis

Badalamente

Wang

2016

Clinical Orthopaedics &Amp; Related Research

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Background Conservative and even surgical management of adhesive capsulitis often is prolonged and painful. Management of adhesive capsulitis is lacking evidencebased controlled clinical trials. Questions/Purposes We asked: (1) Does a collagenase clostridium histolyticum (CCH) injection lyse shoulder capsule collagen in adhesive capsulitis and at what dose? (2) Can a shoulder capsule injection be administered extraarticularly? (3) Do CCH injections result in better scores for pain and function than can be achieved with physical therapy among patients with adhesive capsulitis?Methods First, 60 patients with adhesive capsulitis were evaluated by clinical examination. To make the diagnosis of adhesive capsulitis, a patient had to have restricted active ROM of at least 60°in total active ROM in the affected shoulder compared with the unaffected contralateral shoulder; with the scapula stabilized, external rotation with the elbow at the side was a very important determinant. Patients were randomized to receive a single injection of 0.5 mL placebo or 0.145, 0.29, or 0.58 mg CCH. All 60 patients were followed up at 30 days. After that, if patients did not attain treatment thresholds they were eligible for up to five open-label 0.58-mg collagenase injections. For the longer-term followup in the open-label phase, 53 patients (83%) were followed to 12 months, 46 (77%) for 24 months, 36 (60%) for 36 months, 37 (62%) for 48 months, and 25 (42%) for 60 months. The extraarticular injection was directed at the anterior shoulder capsule with the patient in the supine position. To prove that these injections could be delivered reliably to the anterior shoulder capsule extraarticularly, the next study involved volunteers without adhesive capsulitis, in which 10 volunteers received a 10-mL injection of normal saline under ultrasound guidance. Finally, to determine the efficacy and dosing of CCH, four cohorts of 10 patients received up to three ultrasoundguided injections separated by 21 days. These injections were administered at one of four dose-volume levels. A fifth cohort of 10 patients was used as a control group and performed standardized home shoulder exercises only. All patients performed standardized home shoulder exercises three times daily. For Study 3, followup was at 22, 43, 64, and 92 days. No patients were lost to followup. Results In the first study, a single CCH injection did not provide clinically important improvements from baseline in active ROM, passive ROM, and function and pain scores compared with patients who received placebo. UltrasoundThe Stony Brook University Research Foundation and MAB and EDW received funding from Auxilium Pharmaceutical, Inc.

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Section: Discussionsupporting

confidence: 83%

CORR® ORS Richard A. Brand Award: Clinical Trials of a New Treatment Method for Adhesive Capsulitis

Badalamente

Wang

2016

Clinical Orthopaedics &Amp; Related Research

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“…It works by breaking down the extra collagen in the penis that causes this disease [115]. A multicenter, double-blind, phase 3 randomized and placebo-controlled trial supports the efficacy and safety of intralesional CCH in the treatment of the subjective and objective aspects of significant Peyronie's disease in patients with curvature between 30° and 90° [116,117]. Recent studies demonstrated that CCH treatment administered in multiple cycles led to significant benefit in both the psychological and physical aspects of Peyronie's disease.…”

Section: Collagenase As Debriding Agent In Wound Healingmentioning

confidence: 83%

An overview on therapeutic potential and various applications of microbial collagenases

Azmi

Chauhan

Gautam

2017

J Microbiol Biotech Res

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“…This post hoc analysis included data from 2 published clinical trials 27 that evaluated the safety and efficacy of CCH injection in patients with PD (ClinicalTrials.gov identifiers: IMPRESS-I, NCT01221597; IMPRESS-II, NCT01221623). Data were included from patients in a predefined modified intention-to-treat (mITT) population of IMPRESS-I and IMPRESS-II (ie, mITT defined as patients with both a curvature deformity measurement and a PD symptom bother score at screening who received ≥1 injection of study drug and ≥1 postinjection measurement).…”

Section: Methodsmentioning

confidence: 99%

“…27 Briefly, both were double-blind, placebocontrolled, multicenter, 52-week, phase 3 trials that recruited patients from Australia and the United States starting in September 2010 for both studies and ending in March 2012 (IMPRESS II) and April 2012 (IMPRESS I). Eligible patients were men ≥18 years of age with stable PD (diagnosis of PD for ≥12 months) and a penile curvature of 30-90 degrees who were in a heterosexual relationship and participated in vaginal intercourse.…”

Section: Methodsmentioning

confidence: 99%

Factors Associated With Erectile Dysfunction and the Peyronie's Disease Questionnaire in Patients With Peyronie Disease

Şerefoğlu

Smith²,

Kaufman³

et al. 2017

Urology

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OBJECTIVETo elucidate patient characteristics that impact symptom-related bother and erectile function in patients with Peyronie disease (PD). METHODSA post hoc analysis used data from patients with PD (ie, had PD symptoms ≥12 months and penile curvature deformity of 30-90 degrees) who received ≥1 injection of study medication in 2 phase 3 trials of collagenase clostridium histolyticum ( RESULTSPain during intercourse (P = .02) and PD bother (P <.0001) had a significant impact on International Index of Erectile Function, erectile function scores. The Peyronie's Disease Questionnaire bother domain score was significantly affected by penile curvature deformity, penile shortening, pain during intercourse, and the presence of plaques (P ≤.0005 for all), with pain during intercourse having the greatest impact (maximum likelihood estimation ± standard error = .496 ± .030; P <.0001). Erectile function did not appear to be directly influenced by the presence of plaques, penile curvature deformity, or penile shortening but was associated with PD bother and penile pain. CONCLUSIONThis post hoc analysis provides a conceptual framework through which disease characteristics may impact PD-related bother and erectile function in patients with PD. UROLOGY 107: 155-160, 2017. © 2017 The Author(s). Published by Elsevier Inc. P eyronie disease (PD) is a penile condition that is characterized by focal fibrosis of the tunica albuginea that results in the formation of plaque(s), curvature or deformation of the penis, and, in some cases, pain. 1 The prevalence of PD ranges from 3.2% to 11.8% of men, depending on the definition of PD used and the population studied. [2][3][4] The underlying cause of PD is unknown but likely involves abnormal wound healing. 5 This abnormal response facilitates collagen deposition, changes in collagen fiber content, and plaque formation. [5][6][7] Most patients with PD present between the ages of 52 and 57 years. 2,8 Although pain typically resolves over time, 1 penile curvature or deformity persists and may impact patients' psychological health, relationships with their sexual partners, and emotional well-being. 9,10 For example, a singlecenter, cross-sectional study demonstrated that more than half of patients with PD experienced relationship problems because of the condition, and 81% reported emotional problems. 9 Furthermore, an observational study of 92 men with PD demonstrated that almost half (48%) indicated that they were depressed and that the depression had not resolved over time. 11 Interestingly, in that study, depression was significantly associated with patients' perception of penile shortening, 11 suggesting that depression may

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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

Abstract: IMPRESS I and II support the clinical efficacy and safety of collagenase C. histolyticum for the physical and psychological aspects of Peyronie disease.

Cited by 376 publications

References 20 publications

CORR® ORS Richard A. Brand Award: Clinical Trials of a New Treatment Method for Adhesive Capsulitis

CORR® ORS Richard A. Brand Award: Clinical Trials of a New Treatment Method for Adhesive Capsulitis

An overview on therapeutic potential and various applications of microbial collagenases

Factors Associated With Erectile Dysfunction and the Peyronie's Disease Questionnaire in Patients With Peyronie Disease

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