Clinical Efficacy of Collagenase Clostridium Histolyticum in the Treatment of Peyronie’s Disease by Baseline Penile Curvature Severity Stratum: Results from Two Large Double-Blind, Randomized, Placebo-Controlled Phase 3 Studies
Larry Lipshultz; Martin Gelbard; Christopher Love; Ted Smith; James Tursi; Gregory Kaufman; Abraham Morgentaler. Moderated Poster AUA 2013. Abstract #1230

Introduction and Objectives

The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies (IMPRESS) I and II examined the clinical efficacy of collagenase clostridium histolyticum (CCH) in subjects with Peyronie’s disease (PD). These large identical phase 3 randomized, double-blind, placebo-controlled studies examined percent change from baseline in penile curvature deformity determined using angular measurement of pharmacologic erection and PD symptom bother score from the PD questionnaire (PDQ) as co-primary endpoints. We examine whether CCH treatment outcomes from baseline to 52 weeks differed by baseline penile curvature severity stratum, 30°â€“60° versus 61°â€“90°.

Methods

The identical IMPRESS I (N=303) and II (N=309) phase 3 studies examined CCH treatment through a maximum of 4 treatment cycles, each separated by a 6-week period. Subjects received up to 8 injections of 0.58 mg CCH, two injections per cycle separated by approximately 24–72 hours, with the second injection in each followed 24–72 h later by plaque modeling. Subjects were stratified by degree of penile curvature deformity at baseline (30°â€“60° versus 61°â€“90°) and randomized to CCH or placebo (2:1 in favor of CCH).

Results

In both studies, CCH-treated subjects with baseline curvature deformity 30°â€“60° and 61°â€“90° showed improvement from baseline in percent change curvature deformity (IMPRESS I: -39.1 and -30.9; IMPRESS II: -28.1 and -38.3; Table 1) and PD symptom bother (IMPRESS I: -3.6 and -1.9; IMPRESS II: -2.2 and -3.0; Table 2).

Conclusions

Men with penile curvature deformity 30°â€“60° responded as well to CCH treatment as did men with curvature deformity 61°â€“90°. The IMPRESS I and II studies support the clinical efficacy of CCH treatment compared with placebo for both the physical and psychological aspects of PD regardless of the baseline severity of the penile curvature deformity.

Sources of Funding: Auxilium Pharmaceuticals, Inc.