Abstract
Introduction and Objective: Three phase 3 studies have been conducted to examine the safety and efficacy of collagenase clostridium histolyticum (CCH) in subjects with Peyronie’s disease (PD). The effect of CCH on change in penile curvature deformity from baseline to end of study was analyzed by the subjects’ duration of disease or degree of plaque calcification. Methods: All subjects within the phase 3 studies (2 randomized, doubleblind, placebo-controlled; 1 open-label [interim data]) and who were treated with CCH received up to 8 injections of CCH (0.58 mg) with 2 injections per cycle separated by about 24 to 72 hours, with the second injection followed 24 to 72 hours later by plaque modeling. A maximum of up to 4 cycles each was allowed, with each cycle separated by a 6-week interval. Penile x-ray or ultrasound findings were used to determine the degree of plaque calcification (no calcification, non-contiguous stippling, and contiguous calcification that did not interfere with the injection). Results: CCH-treated subjects (N=775) were stratified by duration of disease: 1-2 years (n=280), >2 to ≤4 years (n=266), and >4 years (n=229). Change in mean curvature deformity by duration of disease is shown in Figure 1 and by degree of plaque calcification in Figure 2. Duration of disease had no relationship to the degree of calcification (no calcification=3.8 years, non-contiguous stippling=4.2 years, and contiguous calcification that did not interfere with the injection=3.3 years). Conclusions: Treatment with CCH resulted in improvements in curvature deformity regardless of duration of disease or level of plaque calcification; although small differences were noted within the subgroups, they are not expected to be clinically meaningful. The observation that the duration of disease had no relationship with the degree of calcification in this population warrants further exploration. Presented at the American Urological Association’s 2013 Annual Meeting, May 4 8, 2013, San Diego, CA. • CCH is approved for treatment of adults with Dupuytren’s contracture (DC) with a palpable cord.7 Two identical, randomized, doubleblind, placebo-controlled, pivotal, phase 3 clinical trials (IMPRESS I and II) were conducted to investigate the use of CCH (followed by a modeling procedure) in subjects with PD – A recently published analysis of this data showed that CCHtreated subjects had a significantly greater improvement in penile curvature deformity compared with placebo subjects (34% vs 18.2%; P<0.0001)8 – Significant improvements in the PD symptom bother domain score for CCH-treated subjects compared with placebo subjects were also observed (-2.8±3.8 vs -1.8±3.5; P=0.0037)
Published Version
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