Humoral immune responses in Peyronie's disease patients receiving clostridial collagenase therapy

Human IgG and IgE antibody responses to clostridial collagenase (Nucleolysin) were monitored in 150 untreated healthy blood donors and 44 patients receiving intrapenile injections of collagenase for treatment of Peyronie's disease. Pre, 1 and/or 2 month post treatment sera were analyzed in radioimmunoassays for human IgG and IgE antibodies using solid phase purified Cl. histolyticum collagenase to extract antibodies from serum and 125I-Protein A or rabbit anti-human IgE to detect bound IgG and IgE, respectively. IgG and IgE antibody levels greater than 2.5 Units and 0.2 per cent Bmax, respectively, were considered positive if the binding was greater than 80 per cent inhibitable with soluble collagenase. IgG anti-collagenase was detected in 34 per cent of the 150 healthy controls and 58 per cent (24/41) of untreated Peyronie's disease patients. Intralesional injection of 3,000 to 12,650 Units of collagenase induced an increase of two- to 10-fold in the IgG levels at one to two months in 88 per cent of patients. Of the 186 individuals tested, only one (0.5 per cent) had detectable collagenase-specific IgE antibody in his serum as defined by positive threshold and antigen inhibition criteria.