Safety Profile of Collagenase Clostridium Histolyticum Stratified by Degree of Penile Curvature in Patients with Peyronie's Disease

To examine the safety of collagenase clostridium histolyticum (CCH) in adult males with penile curvature deformity <30°. Collagenase clostridium histolyticum is indicated for treatment of Peyronie's disease (PD) in adult males with palpable plaque and a penile curvature deformity ≥30° at start of therapy; however, during treatment, patients may receive CCH injections when penile curvature deformity is <30°.

Patients who received ≥2 CCH treatment cycles in 2 phase 3 studies (IMPRESS I and II) were included. All patients had penile curvature ≥30° at the beginning of treatment and could receive up to 4 treatment cycles. The rate and number of treatment-related adverse events (TRAEs) with CCH treatment were compared between patients with penile curvature deformity ≥30° and penile curvature <30°.

The number of CCH treatment cycles included in the current analysis totaled 1204 and 289 cycles in patients with penile curvature deformity ≥30° and <30°, respectively. The incidence of most TRAEs was similar between groups. Rates of penile swelling (21.1% vs 14.5%, P=0.007), penile hemorrhage (12.8% vs 8.9%; P=0.046), and skin hyperpigmentation (1.0% vs 0.1%; P=0.025) were significantly higher in the <30° group. The occurrence of serious TRAEs was similar between groups.

No clinically meaningful differences were observed with TRAE rates when CCH injections were administered at penile curvature deformity ≥30° versus CCH injections at penile curvature deformity <30°. These findings highlight the safety of continued CCH injections for patients who have achieved penile curvature deformity <30° after an initial treatment cycle of CCH.

Urology. 2017 May 10 [Epub ahead of print]

Wayne J G Hellstrom, Ronny B W Tan, Genzhou Liu

Tulane University Health Sciences Center, New Orleans, LA, USA; Department of Urology, Tan Tock Seng Hospital, Singapore; Endo Pharmaceuticals Inc., Malvern, PA, USA. Electronic address: ., Tulane University Health Sciences Center, New Orleans, LA, USA; Department of Urology, Tan Tock Seng Hospital, Singapore; Endo Pharmaceuticals Inc., Malvern, PA, USA.

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