Collagenase clostridium histolyticum delivers incremental benefits across treatment cycles for Peyronie’s disease

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.

Reference

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.