{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T17:38:08Z","timestamp":1791999488522,"version":"4.4.0"},"reference-count":17,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2015,5,13]],"date-time":"2015-05-13T00:00:00Z","timestamp":1431475200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Auxilium Pharmaceuticals"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2015,11]]},"abstract":"\n Objective<\/jats:title>\n \n To examine the safety of intralesional injection of collagenase\n Clostridium histolyticum<\/jats:italic>\n (\n CCH<\/jats:styled-content>\n ) for the treatment of Peyronie's disease (\n PD<\/jats:styled-content>\n ), using a pooled safety analysis of patients who received at least one dose of\n CCH<\/jats:styled-content>\n in any of six clinical studies.\n <\/jats:p>\n <\/jats:sec>\n \n Patients and Methods<\/jats:title>\n \n Patients from six clinical studies, including three randomised, double\u2010blind, placebo\u2010controlled studies and three open\u2010label safety and efficacy studies, were included if they had received at least one dose of 0.58\u00a0mg\n CCH<\/jats:styled-content>\n . Adverse events (\n AE<\/jats:styled-content>\n s), including treatment\u2010emergent\n AE<\/jats:styled-content>\n s, treatment\u2010related\n AE<\/jats:styled-content>\n s, and serious\n AE<\/jats:styled-content>\n s (\n SAE<\/jats:styled-content>\n s), were characterised. Potential immunogenicity\u2010related\n AE<\/jats:styled-content>\n s were evaluated through examination of increased anti\u2010\n AUX<\/jats:styled-content>\n \u2010I and anti\u2010\n AUX<\/jats:styled-content>\n \u2010\n II<\/jats:styled-content>\n antibody levels,\n AE<\/jats:styled-content>\n s, and reported terms possibly associated with immunological or hypersensitivity events.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Overall, 85.8% of 1\u00a0044 pooled patients reported at least one treatment\u2010related\n AE<\/jats:styled-content>\n . The most frequently reported (\u226525.0% of patients) treatment\u2010related\n AE<\/jats:styled-content>\n s included penile haematoma (82.7% had the verbatim \u2018penile bruising\u2019), penile pain, and penile swelling. Most patients (75.2%) had mild\u2010 or moderate\u2010severity treatment\u2010related\n AE<\/jats:styled-content>\n s, and 14.2% had no treatment\u2010related\n AE<\/jats:styled-content>\n s. Nine patients (0.9%) had treatment\u2010related\n SAE<\/jats:styled-content>\n s: five with penile haematoma and four with corporal rupture. There was no association between\n AE<\/jats:styled-content>\n s and anti\u2010\n AUX<\/jats:styled-content>\n \u2010I or anti\u2010\n AUX<\/jats:styled-content>\n \u2010\n II<\/jats:styled-content>\n antibody levels across treatment cycles, and no systemic hypersensitivity reactions occurred.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n This pooled safety analysis shows that although non\u2010serious and serious treatment\u2010related\n AE<\/jats:styled-content>\n s can occur after\n CCH<\/jats:styled-content>\n treatment for\n PD<\/jats:styled-content>\n , most were non\u2010serious and the\n SAE<\/jats:styled-content>\n s were manageable. Providers should be prepared to manage possible\n SAE<\/jats:styled-content>\n s.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/bju.13120","type":"journal-article","created":{"date-parts":[[2015,3,27]],"date-time":"2015-03-27T18:30:51Z","timestamp":1427481051000},"page":"815-822","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":55,"title":["Analysis of the clinical safety of intralesional injection of collagenase\n Clostridium histolyticum<\/i>\n (\n CCH<\/scp>\n ) for adults with Peyronie's disease (\n PD<\/scp>\n )"],"prefix":"10.1111","volume":"116","author":[{"suffix":"III","given":"Culley C.","family":"Carson","sequence":"first","affiliation":[{"name":"Department of Surgery University of North Carolina Chapel Hill NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hossein","family":"Sadeghi\u2010Nejad","sequence":"additional","affiliation":[{"name":"Rutgers New Jersey Medical School and Hackensack University Medical Center Hackensack NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James P.","family":"Tursi","sequence":"additional","affiliation":[{"name":"Auxilium Pharmaceuticals Chesterbrook PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ted M.","family":"Smith","sequence":"additional","affiliation":[{"name":"Auxilium Pharmaceuticals Chesterbrook PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory J.","family":"Kaufman","sequence":"additional","affiliation":[{"name":"Auxilium Pharmaceuticals Chesterbrook PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Gilbert","sequence":"additional","affiliation":[{"name":"Auxilium Pharmaceuticals Chesterbrook PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanton C.","family":"Honig","sequence":"additional","affiliation":[{"name":"Department of Urology Yale University School of Medicine New Haven CT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,5,13]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ucl.2007.08.017"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1743-6109.2008.00883.x"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2012.01.032"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2013.01.087"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1021\/bi00377a004"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0363-5023(96)80368-6"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1517\/14712598.2010.510509"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0810866"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhsa.2010.08.007"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11552-012-9407-3"},{"key":"e_1_2_7_12_1","volume-title":"Xiaflex\u00ae (collagenase Clostridium histolyticum) [Prescribing Information]","year":"2014"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5347(06)00517-9"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0090-4295(97)00700-0"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11255-009-9522-4"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2011.544252"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1743-6109.2010.01850.x"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1743-6109.2008.01081.x"}],"container-title":["BJU International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fbju.13120","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bju.13120","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T14:37:51Z","timestamp":1761748671000},"score":1,"resource":{"primary":{"URL":"https:\/\/bjui-journals.onlinelibrary.wiley.com\/doi\/10.1111\/bju.13120"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,5,13]]},"references-count":17,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2015,11]]}},"alternative-id":["10.1111\/bju.13120"],"URL":"https:\/\/doi.org\/10.1111\/bju.13120","archive":["Portico"],"relation":{},"ISSN":["1464-4096","1464-410X"],"issn-type":[{"value":"1464-4096","type":"print"},{"value":"1464-410X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,5,13]]},"assertion":[{"value":"2015-05-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}