Men receiving collagenase clostridium histolyticum (CCH, Xiaflex) for Peyronie’s disease appeared to have incremental benefits from each of 4 treatment cycles.
The finding was presented at the 2021 Sexual Medicine Society of North American Fall Scientific Meeting by Matthew J. Ziegelmann, MD, of Mayo Clinic, Rochester, Minnesota.1
As explained by the investigators, the safety and efficacy of CCH had previously been demonstrated in two phase 3, randomized, double-blind, placebo-controlled trials in which CCH injections were administered in up to 4 treatment cycles at 6 week intervals. Each cycle comprised 2 injections administered 1 to 3 days apart. For the current study, the authors sought to evaluate incremental changes in penile curvature during the course of CCH treatment.
The investigators utilized pooled data from the 2 placebo-controlled trials to conduct a posthoc analysis. They calculated the change from baseline and from previous penile curvature measurement after each treatment cycle (weeks 6, 12, 18, and 24). A 2-sample t-test was used to compare mean percentage change in penile curvature. The percentage of patients who were classified as treatment responders (curvature reduction of at least 20%) was compared using Fisher’s exact test.
For the study, 832 men were evaluated, 551 of whom received CCH treatment and 281 of whom received placebo. At baseline, the mean ± standard deviation (SD) penile curvature was 50.6±14.7° in the CCH group and 50.4±14.1° in the placebo group. Compared with baseline, the mean ± SD percentage change in penile curvature was as follows:
• -12.8±20.3% for CCH vs -6.2±18.8% for placebo after the first treatment cycle
• -22.6±23.5% vs -10.6±23.1% after the second treatment cycle
• -29.9±25.0% vs -14.6±24.0% after the third treatment cycle
• -33.1±28.0% vs -16.6±25.5% after the fourth treatment cycle.
When comparing change from the previous measurement, ie, between first and second treatment cycle, between second and third treatment cycle, etc, mean ± SD percentage change in penile curvature was as follows:
• 11.1±21.8% vs 5.0±16.4% after the second treatment cycle (P < .001 vs placebo)
• 9.6±21.8% vs 3.9±17.0% after the third treatment cycle (P < .001)
• 6.3±23.0% vs 2.0±17.2% after the fourth (P = .009 vs placebo).
In addition, the percentage of patients with at least a 20% reduction in penile curvature since the previous measurement was as follows:
• 29.9% for patients receiving CCH vs 18.3% in the placebo group after the first treatment cycle (P = .0003)
• 29.1% vs 16.9%, respectively, after the second treatment cycle (P = .0002)
• 25.2% vs 12.8%, respectively, after the third treatment cycle (P < .0001)
• 20.2% vs 10.9%, respectively, after the fourth treatment cycle (P =.001).
The investigators also reported that in patients with a response after 2 treatment cycles, 40.2% of patients treated with CCH had an additional reduction in curvature of at least 20% after completing 4 treatment cycles vs 19.5% of patients receiving placebo (P = .001). In addition, in patients with less than a 20% reduction after 2 treatment cycles, 29.8% of patients receiving CCH were classified as treatment responders after completing the fourth treatment cycle compared with 20.8% of patients receiving placebo (P = .057).
“Results would suggest benefits with performing a full series of 4 CCH injections, even among men who are initial non-responders,” the authors concluded.
1. Ziegelmann M, Liu G, McLane M, Hu Y, Trost L. Collagenase clostridium histolyticum treatment for Peyronie’s disease: analysis of outcomes and cumulative benefits after each injection cycle. Paper presented at 2021 Sexual Medicine Society of North American Fall Scientific Meeting; October 21-24; Scottsdale, Arizona. Abstract 059.