{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T05:24:30Z","timestamp":1780464270047,"version":"3.54.1"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,5,16]],"date-time":"2024-05-16T00:00:00Z","timestamp":1715817600000},"content-version":"vor","delay-in-days":45,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,4,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Crohn\u2019s disease (CD) is an immune-mediated inflammatory disorder of the gastrointestinal tract with perianal disease being one of the challenging possible manifestations. Here, we report, an ad hoc analysis of the safety and effectiveness of 1-year use of ustekinumab (UST) for CD in patients with perianal manifestations using post-marketing surveillance (PMS) data in Japan.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Among 341 patients enrolled in the PMS, 229 and 224 patients who had baseline Crohn\u2019s Disease Activity Index (CDAI) data used for evaluating perianal manifestations were included in the safety and efficacy analysis sets, respectively. Incidence of adverse drug reactions, clinical remission, the mean or its change in CDAI scores, and CDAI items were evaluated through week 52 in the presence or absence of perianal manifestations at baseline. The prevalence of perianal manifestations was also described.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Comparing patients with and without baseline perianal manifestations at week 52, there was no difference in ADR incidence (9.1% [n\u2005=\u200566] vs. 15.3% [n\u2005=\u2005163]), no difference in clinical remission (68.3% vs. 59.9%; P\u2005=\u20050.269), and decreased mean change of CDAI score (\u221282.9 [n\u2005=\u200560] vs. \u221268.8 [n\u2005=\u2005137]). The proportion of patients with perianal manifestations decreased after UST treatment in both biologics-na\u00efve patients (23.5% [n\u2005=\u20054\/17]) and patients who had received biologics (35.0% [n\u2005=\u200514\/40]) at week 52.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In Japanese clinical practice, UST is safe and effective in CD patients with and without perianal manifestations. The therapy might be also beneficial in those with manifestations regardless of prior use of other biologics.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/crocol\/otae035","type":"journal-article","created":{"date-parts":[[2024,5,15]],"date-time":"2024-05-15T13:25:17Z","timestamp":1715779517000},"source":"Crossref","is-referenced-by-count":1,"title":["Safety and Effectiveness of Ustekinumab for Crohn\u2019s Disease With Perianal Manifestations: Ad hoc Analysis Data From 1-Year Post-Marketing Surveillance Study in Japan"],"prefix":"10.1093","volume":"6","author":[{"given":"Katsumasa","family":"Nagano","sequence":"first","affiliation":[{"name":"Janssen Pharmaceutical K.K. , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Tsuchiya","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutical K.K. , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1830-4382","authenticated-orcid":false,"given":"Teita","family":"Asano","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutical K.K. , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Yamazaki","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutical K.K. , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonoko","family":"Tominaga","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutical K.K. , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9786-3854","authenticated-orcid":false,"given":"Takayuki","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Internal Medicine, School\u00a0of Medicine, Iwate Medical University , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,5,16]]},"reference":[{"issue":"3","key":"2024060109465921000_CIT0001","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1016\/j.gtc.2017.05.003","article-title":"Epidemiology, natural history, and risk stratification of Crohn\u2019s disease","volume":"46","author":"Aniwan","year":"2017","journal-title":"Gastroenterol Clin North Am."},{"issue":"11","key":"2024060109465921000_CIT0002","doi-asserted-by":"crossref","first-page":"652","DOI":"10.1038\/nrgastro.2017.104","article-title":"Perianal fistulizing Crohn\u2019s disease: pathogenesis, diagnosis and therapy","volume":"14","author":"Pan\u00e9s","year":"2017","journal-title":"Nat Rev Gastroenterol Hepatol."},{"issue":"8","key":"2024060109465921000_CIT0003","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.1093\/ecco-jcc\/jjad038","article-title":"Diagnosis and clinical features of perianal lesions in newly diagnosed Crohn\u2019s disease: subgroup analysis from inception cohort registry study of patients with Crohn\u2019s disease (iCREST-CD)","volume":"17","author":"Yamamoto","year":"2023","journal-title":"J Crohns Colitis."},{"issue":"3","key":"2024060109465921000_CIT0004","doi-asserted-by":"crossref","first-page":"650","DOI":"10.1053\/j.gastro.2005.12.019","article-title":"Predictors of Crohn\u2019s disease","volume":"130","author":"Beaugerie","year":"2006","journal-title":"Gastroenterology."},{"issue":"8","key":"2024060109465921000_CIT0005","doi-asserted-by":"crossref","first-page":"948","DOI":"10.1080\/00365520801957149","article-title":"Predictors of severe Crohn\u2019s disease","volume":"43","author":"Loly","year":"2008","journal-title":"Scand J Gastroenterol."},{"issue":"11","key":"2024060109465921000_CIT0006","doi-asserted-by":"crossref","first-page":"867","DOI":"10.1007\/s00535-022-01907-2","article-title":"Characteristics of adult patients newly diagnosed with Crohn\u2019s disease: interim analysis of the nation-wide inception cohort registry study of patients with Crohn\u2019s disease in Japan (iCREST-CD)","volume":"57","author":"Matsuoka","year":"2022","journal-title":"J Gastroenterol."},{"issue":"4","key":"2024060109465921000_CIT0007","doi-asserted-by":"crossref","first-page":"875","DOI":"10.1053\/gast.2002.32362","article-title":"The natural history of fistulizing Crohn\u2019s disease in Olmsted County, Minnesota","volume":"122","author":"Schwartz","year":"2002","journal-title":"Gastroenterology."},{"issue":"12","key":"2024060109465921000_CIT0008","doi-asserted-by":"crossref","first-page":"1070","DOI":"10.1007\/s00535-019-01603-8","article-title":"Estimated prevalence of ulcerative colitis and Crohn\u2019s disease in Japan in 2014: an analysis of a nationwide survey","volume":"54","author":"Murakami","year":"2019","journal-title":"J Gastroenterol."},{"issue":"2","key":"2024060109465921000_CIT0009","doi-asserted-by":"crossref","first-page":"111","DOI":"10.5217\/ir.2016.14.2.111","article-title":"Changing epidemiological trends of inflammatory bowel disease in Asia","volume":"14","author":"Ng","year":"2016","journal-title":"Intest Res"},{"issue":"10080","key":"2024060109465921000_CIT0010","doi-asserted-by":"crossref","first-page":"1741","DOI":"10.1016\/S0140-6736(16)31711-1","article-title":"Crohn\u2019s disease","volume":"389","author":"Torres","year":"2017","journal-title":"Lancet."},{"issue":"6","key":"2024060109465921000_CIT0011","doi-asserted-by":"crossref","first-page":"597","DOI":"10.1080\/17474124.2018.1480936","article-title":"Clinical updates on perianal fistulas in Crohn\u2019s disease","volume":"12","author":"Rackovsky","year":"2018","journal-title":"Expert Rev Gastroenterol Hepatol"},{"issue":"9","key":"2024060109465921000_CIT0012","doi-asserted-by":"crossref","first-page":"1381","DOI":"10.1136\/gutjnl-2013-306709","article-title":"A global consensus on the classification, diagnosis and multidisciplinary treatment of perianal fistulising Crohn\u2019s disease","volume":"63","author":"Gecse","year":"2014","journal-title":"Gut."},{"issue":"1","key":"2024060109465921000_CIT0013","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1093\/ibd\/izy247","article-title":"Clinical practice guideline for the medical management of perianal fistulizing Crohn\u2019s disease: the Toronto consensus","volume":"25","author":"Steinhart","year":"2019","journal-title":"Inflamm Bowel Dis."},{"issue":"1","key":"2024060109465921000_CIT0014","first-page":"1","article-title":"ECCO-ESCP consensus on surgery for Crohn\u2019s disease","volume":"12","author":"Bemelman","year":"2018","journal-title":"J Crohns Colitis."},{"issue":"1","key":"2024060109465921000_CIT0015","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1093\/ecco-jcc\/jjz180","article-title":"ECCO guidelines on therapeutics in Crohn\u2019s disease: medical treatment","volume":"14","author":"Torres","year":"2020","journal-title":"J Crohns Colitis."},{"issue":"20","key":"2024060109465921000_CIT0016","doi-asserted-by":"crossref","first-page":"1946","DOI":"10.1056\/NEJMoa1602773","article-title":"Ustekinumab as induction and maintenance therapy for Crohn\u2019s disease","volume":"375","author":"Feagan","year":"2016","journal-title":"N Engl J Med."},{"issue":"6","key":"2024060109465921000_CIT0017","doi-asserted-by":"crossref","first-page":"535","DOI":"10.4161\/mabs.3.6.17815","article-title":"Discovery and mechanism of ustekinumab: a human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated 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disease in Japanese post-marketing surveillance in biologic-naive and -experienced conriemed","volume":"5","author":"Nagano","year":"2023","journal-title":"Crohns Colitis 360."},{"issue":"3","key":"2024060109465921000_CIT0024","doi-asserted-by":"crossref","first-page":"578","DOI":"10.1016\/j.cgh.2021.02.025","article-title":"Five-year efficacy and safety of ustekinumab treatment in Crohn\u2019s disease: The IM-UNITI Trial","volume":"20","author":"Sandborn","year":"2022","journal-title":"Clin Gastroenterol Hepatol."},{"issue":"Supplement_1","key":"2024060109465921000_CIT0025","doi-asserted-by":"crossref","first-page":"S049","DOI":"10.1093\/ecco-jcc\/jjz203.052","article-title":"DOP13 Clinical and endoscopic response to ustekinumab in Crohn\u2019s disease: week 16 interim analysis of the STARDUST trial","volume":"14","author":"Danese","year":"2020","journal-title":"J Crohns Colitis."},{"issue":"2","key":"2024060109465921000_CIT0026","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1016\/j.cgh.2015.09.018","article-title":"Subcutaneous ustekinumab provides clinical benefit for two-thirds of patients with Crohn\u2019s disease refractory to anti-tumor necrosis factor agents","volume":"14","author":"Wils","year":"2016","journal-title":"Clin Gastroenterol Hepatol."},{"issue":"suppl_1","key":"2024060109465921000_CIT0027","doi-asserted-by":"crossref","first-page":"S400","DOI":"10.1093\/ecco-jcc\/jjx002.750","article-title":"P626 Ustekinumab for the treatment of perianal fistulas in patients with Crohn\u2019s disease","volume":"11","author":"Battat","year":"2017","journal-title":"J Crohns Colitis."},{"issue":"7","key":"2024060109465921000_CIT0028","doi-asserted-by":"crossref","first-page":"1662","DOI":"10.1097\/MIB.0000000000000842","article-title":"Ustekinumab for the treatment of refractory Crohn\u2019s disease: the Spanish experience in a large 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Gastroenterol."},{"issue":"5","key":"2024060109465921000_CIT0031","doi-asserted-by":"crossref","first-page":"1059","DOI":"10.1016\/j.cgh.2021.09.028","article-title":"Efficacy and safety of 2 vedolizumab intravenous regimens for perianal fistulizing Crohn\u2019s disease: ENTERPRISE Study","volume":"20","author":"Schwartz","year":"2022","journal-title":"Clin Gastroenterol Hepatol."},{"key":"2024060109465921000_CIT0032","author":"ClinicalTrials.gov. 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