Clinical ef

cacy of collagenase

Clostridium

histolyticum

in the treatment of Peyronie

’

s disease

by subgroup: results from two large, double-blind,

randomized, placebo-controlled, phase III studies

Larry I. Lipshultz, Irwin Goldstein*, Allen D. Seftel

†

, Gregory J. Kaufman

‡

, Ted M. Smith

‡

James P. Tursi

‡

and Arthur L. Burnett

Scott Department of Urology, Baylor College of Medicine, Houston, TX, *San Diego Sexual Medicine, Alvarado Hospital,

San Diego, CA,

†

Cooper University Hospital, Camden, NJ,

‡

Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, and

Johns Hopkins Medicine, Baltimore, MD, USA

Objectives

To examine the ef

cacy of intralesional collagenase

Clostridium histolyticum

(CCH) in de

ned subgroups of

patients with Peyronie

’

s disease (PD).

Patients and Methods

The ef

cacy of CCH compared with placebo, assessed from

baseline to week 52, was examined in subgroups of

participants from the Investigation for Maximal Peyronie

’

Reduction Ef

cacy and Safety Studies (IMPRESS) I and II.

The subgroups were de

ned according to: severity of penile

curvature deformity at baseline (30

–

[

492] and 61

–

[

120]); PD duration (1 to

≤

201],

2to

≤

[

212] and

4yea

rs[

199]); degree of plaque calci

cation

(no calci

cation [

447], non-contiguous stippling

[

103] and contiguous calci

cation that did not interfere

with injection of CCH [

62]); and baseline erectile function

(International Index of Erectile Function [IIEF] scores 1

–

[

22], 6

–

16 [

106] and

≥

17 [

480]).

Results

Reductions in penile curvature deformity and PD symptom

bother were observed in all subgroups. Penile curvature

deformity reductions were signi

cantly greater with CCH

than with placebo for the following subgroups: baseline penile

curvature 30

–

and 61

–

; disease duration

2to

≤

4 years

and

4 years; no calci

cation; and IIEF score

≥

17 (high IIEF-

erectile function score;

0.05 for all). PD symptom bother

reductions were signi

cantly greater in the CCH group for:

penile curvature 30

–

; disease duration

4 years; no

calci

cation; and IIEF score 1

–

5 (no sexual activity) and

≥

(

0.05 for all).

Conclusions

In this analysis, clinical ef

cacy of CCH treatment for

reducing penile curvature deformity and PD symptom bother

was found across subgroups. In the IMPRESS I and II overall,

adverse events (AEs) were typically mild or moderate,

although treatment-related serious AEs, including corporal

rupture or penile haematoma, occurred. Future studies could

be considered to directly assess the ef

cacy and safety of

CCH treatment in de

ned subgroups of PD patients, with the

goal of identifying predictors of optimum treatment success.

Keywords

collagenase, ef

cacy, plaque, Peyronie

’

s disease, subgroups

Introduction

Peyronie

’

s disease (PD) is a disorder characterized by a

disorganized, excessive deposition of collagen that forms a

plaque within the tunica albuginea surrounding the corpus

cavernosum [1

–

3]. The plaque restricts tunical lengthening

on the affected side during erection, which can lead to penile

curvature deformity, discomfort and erectile dysfunction [2,4].

PD can also be associated with psychosocial effects such as

bother, depression and relationship dif

culties [5

–

8].

Surgical treatment of PD is typically offered in several

circumstances, including cases of disease stabilization, erectile

dysfunction that does not respond to medication, curvature

deformity severe enough to impair sexual intercourse, or where

a patient wants treatment with rapid results [9,10]; however,

there are risks associated with surgery, such as penile shortening,

altered penile sensation, residual penile curvature deformity, and

persistent or new-onset erectile dysfunction [10

–

13].

Minimally invasive therapeutic options for PD may provide

disease stabilization, reduction of deformity, and improved

BJU Int

2015;

116:

650

–

656

wileyonlinelibrary.com

Published by John Wiley & Sons Ltd. www.bjui.org

Sexual Medicine