To examine the long-term (5-year) efficacy and safety of collagenase clostridium histolyticum (CCH) therapy in men with Peyronie's disease (PD) and varying degrees of plaque calcification.
CCH-treated adult men from the 12-month IMPRESS I/II or 9-month open-label studies were eligible. Degree of plaque calcification (no calcification, noncontiguous stippled calcification, or calcification that did not interfere with CCH injection) were determined by penile x-ray or ultrasound. Penile curvature deformity and Peyronie's Disease Questionnaire (PDQ) responses were assessed annually for up to 5 years, with ≥6 months between consecutive visits.
For no calcification group, from baseline to last (Reference) visit during the prior studies (n=160), mean penile curvature improved by 20.9±16.3 degrees (39.3%) with CCH. Similar improvements with CCH from baseline to Reference were observed in stippled calcification (n=27; improvement of 24.1±20.2 degrees [42.7%]) and calcification (n=27; improvement of 21.7±14.8 degrees [43.3%]) subgroups. At Year 5 follow-up in no calcification group (n=119), an additional 10.0% improvement in mean penile curvature versus Reference (4.3 degrees) occurred. Penile curvature improvements seen at Reference in stippled calcification and calcification groups were maintained through Year 5. Additional numeric improvements in 3 PDQ domains were observed at Year 5 visit versus baseline scores. No long-term safety issues were identified.
This first report of long-term (5-year) CCH clinical trial outcomes in a population with penile plaque calcification demonstrates that nonsurgical intralesional CCH therapy is an appropriate PD treatment in men with penile plaque calcification that is stippled or does not impede CCH injection.
Urology. 2020 Sep 04 [Epub ahead of print]
Irwin Goldstein, Michael P McLane, Qinfang Xiang, Henry R Wolfe, Yiqun Hu, Martin K Gelbard
Alvarado Hospital, San Diego, CA. Electronic address: ., Endo Pharmaceuticals Inc., Malvern, PA., Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, CA.