Presentation Authors: Irwin Goldstein*, San Diego, CA, Larry Lipshultz, Houston, TX, Michael McLane, Yiqun Hu, Steve Xiang, Genzhou Liu, Saji Vijayan, Malvern, PA, Martin Gelbard, Burbank, CA
Introduction: To assess long-term safety and immunogenicity of collagenase clostridium histolyticum (collagenase) and characterize curvature deformity over time in patients previously treated with collagenase for Peyronie&[prime]s disease (PD).
Methods: Follow-up study of patients who received collagenase in 2 large, 12-month, double-blind, placebo-controlled clinical trials (IMPRESS I/II) or one of two 9-month, open-label studies. Eligible patients were followed yearly for up to 5 years after initial collagenase injection. Adverse events (AEs) were collected throughout the study. Penile curvature characterization and PDQ were compared to Reference data (measurements obtained at last visit in 1 of the prior studies).
Results: Of 280 patients enrolled, 204 completed the study. From baseline to last visit (Reference) of the prior studies (n=247), mean Â± SD penile curvature decreased from 51.8 Â± 15.0 degrees to 31.0 Â± 16.1 degrees (improvement of 20.9 Â± 16.2 degrees; 39.5%). At Year 5 follow-up (n=180), there was an additional 9.1% improvement in mean penile curvature versus Reference data (4.3 degrees; 95% CI, 2.3-6.2 degrees; P=0.02). Twenty-nine patients were excluded from the 5-year analysis of curvature characterization: 9 who received additional collagenase injection(s), 2 with penile implants, and 18 with prior surgery for PD. There was a significant mean reduction of PDQ bother score at Year 5 from Reference (n=123; mean reduction (Â± SD), 0.9 Â± 2.5 , P=0.0003). Additional improvements were seen in PDQ pain and psychologic and physical symptoms domains at Year 5 visit versus Reference scores. There was a mean increase of 0.5 Â± 1.29 cm in penile length from Baseline to Reference in prior studies, and the length was maintained to Year 5. AEs were reported in 17.5% (49/280) of patients; none were considered treatment related. No long-term safety issues were identified. There was a trend toward a decrease in the number of anti-AUX-I and anti-AUX-II seropositive patients at Years 4 and 5 (100% in Year 2 to ~98% at Year 4 and 90.9% at Year 5). Mean log antibody titer levels for anti-AUX-I decreased from 4.9 at maximum in previous studies to 3.8, 3.8, and 3.7, in Years 3, 4, and 5, respectively; anti-AUX-II decreased from 4.5 to 3.6, 3.5, and 3.4 in Years 3, 4, and 5, respectively.
Conclusions: This 5-year study did not reveal additional long-term safety or tolerability signals. Most patients continued to have improvement in PD curvature and bother through 5 years of follow-up without additional treatment.
Source of Funding: Endo Pharmaceuticals Inc.