Clinical efficacy, safety, and tolerability of collagenase clostridium histolyticum in the treatment of Peyronie's disease from 2 large double-blind, randomized, placebo-controlled phase 3 studies
Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd. J Urol. 2013 Jan 30. pii: S0022-5347(13)00227-9. doi: 10.1016/j.juro.2013.01.087. [Epub ahead of print]

Source

Urology Associates Medical Group, Burbank, CA, USA. Electronic address: mgelbard@ucla.edu.

Abstract

PURPOSE:

The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies (IMPRESS) I and II examined the clinical efficacy and safety of collagenase clostridium histolyticum (CCH) intralesional injections in subjects with Peyronie's disease (PD). Co-primary outcomes in these identical phase 3 randomized, double-blind, placebo-controlled studies included percent change in penile curvature deformity and change in Peyronie's Disease Questionnaire PD symptom bother score from baseline to 52 weeks.

MATERIALS AND METHODS:

The IMPRESS I (N=417) and II (N=415) studies examined CCH intralesional injections through a maximum of 4 treatment cycles, each separated by 6 weeks. Subjects received up to 8 injections of 0.58 mg CCH, 2 injections per cycle separated by approximately 24-72 hours, with the second injection in each followed 24-72 hours later by penile plaque modeling. Subjects were stratified by degree of penile curvature at baseline (30-60° versus 61-90°) and randomized to CCH or placebo (2:1 in favor of CCH).

RESULTS:

From a post-hoc meta-analysis of IMPRESS I and II data, CCH-treated subjects showed a mean 34% improvement in penile curvature deformity, a mean -17.0±14.8° change per subject, compared with a mean 18.2% improvement in placebo-treated subjects, a mean -9.3±13.6° change per subject (p<0.0001). Mean change in PD symptom bother score was significantly improved in CCH-treated (-2.8±3.8) versus placebo (-1.8±3.5, p=0.0037) subjects. Three corporal rupture serious adverse events occurred and were all surgically repaired.

CONCLUSIONS:

The IMPRESS I and II studies support the clinical efficacy and safety of CCH treatment for both the physical and psychological aspects of PD.