Among patients who did not have a response during the first cycle, 60.8% achieved a response after the fourth.
Men with Peyronie disease showed incremental reductions in penile curvature with each of 4 injection series of collagenase clostridium histolyticum (CCH, Xiaflex), according to data from a post-hoc analysis from 2 phase 3 trials.1,2
CCH was approved by the FDA in 2013. Current prescribing information states that the treatment may be administered in up to 4 treatment cycles, according to the authors.
"The data analysis points to the importance of patient adherence to treatment protocol for efficacy and positive therapeutic outcomes when treating [Peyronie disease] with Xiaflex,” said lead author Matthew J. Ziegelmann in a news release on the findings.2 Ziegelmann is a urologist at Mayo Clinic in Rochester, Minnesota.
In total, 832 men were included in the analysis, 551 of whom received treatment with CCH and 281 of whom received a placebo. Men who underwent treatment with CCH could have received up to 4 cycles. Each cycle consisted of 2 injections of CCH .58 mg, 1 to 3 days apart, in 6-week intervals.
Co-primary efficacy end points included percent change in penile curvature from baseline to week 52 and change in PD symptom bother score from baseline to week 52. A 20% or greater reduction from baseline penile curvature was defined as a successful response to treatment. Mean penile curvature among men in the CCH group was 50.6 degrees at baseline.
Men who underwent treatment with CCH had a significantly greater mean cumulative percent reduction in penile curvature following each cycle of treatment compared with men in the placebo group (P < .001). Among men who completed all 4 cycles of treatment, a -19.8% reduction in mean penile curvature from baseline to week 12 was observed.
A total of 29.9% of men who underwent treatment with CCH had a successful response following the first cycle. Nonresponders were given additional cycles of CCH. Among those who did not have a response during the first cycle, 60.8% achieved a response after the fourth. Among nonresponders with the first 2 cycles, 42.7% achieved a response following the fourth. Similarly, 23.5% of patients who did not have a response throughout the first 3 cycles achieved a response following the fourth.
The authors wrote, “The results of this post hoc analysis of clinical trial data indicated that some men with PD who achieve limited initial response to CCH treatment may benefit from adhering to treatment recommendations and continuing up to 4 treatment cycles, per US prescribing information.”
The investigators also found that men who underwent treatment with CCH had a statistically significant greater mean improvement in symptom bother compared with that seen among men in the placebo group.
1. Ziegelmann M, Hu Y, Xiang Q, Liu G, McLane MP, Trost L. Incremental treatment response by cycle with collagenase clostridium histolyticum for Peyronie’s disease: a pooled analysis of two phase 3 trials. Urology. Published online May 23, 2023. Accessed June 21, 2023. doi:10.1016/j.urology.2023.02.019
2. Endo announces publication of XIAFLEX (collagenase clostridium histolyticum) data analysis in peer-reviewed Urology. News release. Endo International plc. June 5, 2023. Accessed June 21, 2023. https://www.prnewswire.com/news-releases/endo-announces-publication-of-xiaflex-collagenase-clostridium-histolyticum-data-analysis-in-peer-reviewed-urology-301841484.html