Long-Term Safety and Curvature Deformity Characterization in Patients Previously Treated with Collagenase clostridium Histolyticum for Peyronie’s Disease

Human Pharmacokinetics and Safety of Subcutaneous Collagenase Clostridium Histolyticum in Women

“…10,11 A pooled analysis of patients with PD treated with CCH reported that 1.6% of patients (17/1044) from 6 clinical studies discontinued because of AEs 11 ; however, no patients discontinued because of AEs during 5-year follow-up after injection. 12 In 13 trials of CCH for the treatment of DC, 1.3% of patients discontinued because of AEs.…”

“…Immunogenicity profiling has shown that administration of CCH in patients with PD or DC 9,12 or administration of CCH in women with cellulite typically results in seropositivity for anti-AUX-I and/or anti-AUX-II antibodies. In the current study, the majority of the women were seropositive for anti-AUX-I and anti-AUX-II antibodies after CCH treatment, but only 6 women developed neutralizing antibodies.…”

“…8 Safety and immunogenicity data reported in patients with DC or PD demonstrated that CCH treatment is safe and generally well tolerated. [9][10][11][12] Clinical trial and postmarketing surveillance data indicate that the most common adverse events (AEs) associated with CCH administration for the treatment of DC and PD were localized to the injection site, mostly mild to moderate in intensity, and transient. [9][10][11] In 5-year posttreatment follow-up studies of patients with DC (n=644) or PD (n=280), no long-term safety issues with CCH therapy were identified.…”

“…[9][10][11] In 5-year posttreatment follow-up studies of patients with DC (n=644) or PD (n=280), no long-term safety issues with CCH therapy were identified. 9,12 At 5 years posttreatment, >90% of patients treated with CCH for DC and PD were seropositive for anti-AUX-I and anti-AUX-II antibodies. 9,12 Patients with DC or PD treated with CCH produced serum neutralizing antibodies; however, the presence of neutralizing antibodies in patients with PD or DC had no apparent effect on the clinical response or the frequency of adverse reactions.…”

“…9,12 At 5 years posttreatment, >90% of patients treated with CCH for DC and PD were seropositive for anti-AUX-I and anti-AUX-II antibodies. 9,12 Patients with DC or PD treated with CCH produced serum neutralizing antibodies; however, the presence of neutralizing antibodies in patients with PD or DC had no apparent effect on the clinical response or the frequency of adverse reactions. 8,9 doi:10.36849/JDD.2020.5048…”