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Integrated Safety Profile of Collagenase Clostridium Histolyticum in Clinical Studies Evaluating the Treatment of Peyronie’s Disease
Stanton Honig, MD1, Hossein Sadeghi-Nejad, MD2, Ted Smith, PhD3, Gregory Kaufman, MD3, Kimberly Gilbert, RN, MSN3, Culley Carson, MD4.
1The Urology Center, PC, New Haven, CT, USA, 2Center for Male Reproductive Medicine, Hackensack, NJ, USA, 3Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA, 4University of North Carolina, Chapel Hill, NC, USA.
Introduction and Objectives. Peyronie’s disease (PD) is a localized connective tissue disorder of the tunica albuginea of the penis in which a fibrous collagen scar or Peyronie’s plaque develops eventually developing a penile curvature deformity in many patients. Collagenase clostridium histolyticum (CCH) is a novel nonsurgical injection being studied for the treatment of PD. The objective of this study is to summarize the integrated safety of subjects who received at least one dose of CCH in 7 clinical studies (4 phase 2; 3 phase 3).
Methods. The safety database for CCH currently includes 954 PD subjects (6 completed studies and 1 interim) treated with at least one dose of CCH (0.58 mg) administered by injection in phase 2-3 clinical trials. The phase 2 studies (n=166) included up to 9 injections/patient of CCH in varying treatment cycles. The phase 3 studies (n=788) included up to 8 injections/patient in 4 treatment cycles, each cycle consisting of 2 injections, with each cycle separated by approximately 6 weeks.
Results. The 954 subjects were treated with 6701 injections of CCH (0.58 mg) and 65.4% received 4 cycles of treatment (8 injections); 832 (87.2%) subjects completed their assigned study and 122 (12.8%) subjects prematurely discontinued. Of these, 17 subjects discontinued due to an adverse event (AE), of which 9 subjects discontinued for a nonserious AE considered treatment-related (mainly penile or injection site). At least one nonserious AE was reported by 893 (93.7%) subjects. All common AEs (>5% incidence) were either local to the penis, or at the injection site (Table 1). Fifty-eight (6.1%) subjects experienced at least one nonfatal serious AE (50 were not considered related to treatment). Eight subjects had at least one nonfatal serious AE considered to be related to CCH treatment (4 penile hematoma and 4 corporal rupture), resulting in interruption of treatment or drug withdrawal in 7 of 8 cases. There were no events of systemic hypersensitivity. There were 3 deaths among the CCH-treated population during the course of the studies but none were considered to be treatment-related.
Conclusions. Our review of the safety of CCH in the treatment of PD shows that adverse experiences were predominantly nonserious and localized, and serious AEs were localized to the penis in these clinical studies.
Table 1. Common (> 5%) Nonserious Treatment-related Adverse Events by Frequency in Subjects Who Received at Least One Dose of CCH
|Preferred Term||Adverse Event|
a87.2% of treatment-related AEs of penile hematoma had the verbatim “penile bruising.”
b100% of penile hemorrhage had the verbatim “penile ecchymosis.”
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