{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T12:58:26Z","timestamp":1784033906681,"version":"3.55.0"},"reference-count":25,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2022,7,21]],"date-time":"2022-07-21T00:00:00Z","timestamp":1658361600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Gastro and Hepatol"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Aim<\/jats:title><jats:p>Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present safety and efficacy data from patients from East Asia (Japan, Korea, and Taiwan) in OCTAVE Open, an open\u2010label, long\u2010term extension study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients in remission at OCTAVE Open baseline received tofacitinib 5\u00a0mg twice daily (BID); all others received tofacitinib 10\u00a0mg BID. Proportions and IRs (unique patients with events\/100 patient\u2010years) were calculated for adverse events (AEs) of special interest. Efficacy endpoints were evaluated up to 36\u00a0months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In OCTAVE Open, 105\/944 patients were from East Asia (tofacitinib 5\u00a0mg BID, <jats:italic>n<\/jats:italic>\u00a0=\u00a022; tofacitinib 10\u00a0mg BID, <jats:italic>n<\/jats:italic>\u00a0=\u00a083). Overall, 87.6% and 24.8% of patients had AEs and serious AEs, respectively; IRs (95% CI) for AEs of special interest were herpes zoster (HZ; non\u2010serious and serious), 6.07 (3.40\u201310.02); serious infections, 1.47 (0.40\u20133.76); opportunistic infections, 1.91 (0.62\u20134.45); major cardiovascular adverse events, 0.37 (0.01\u20132.04); malignancies (excluding non\u2010melanoma skin cancer [NMSC]), 0.37 (0.01\u20132.04); and NMSC, 0.00 (0.00\u20131.35). No deaths, venous thromboembolic events, or gastrointestinal perforations occurred. At month 36, 68.2% and 54.2% of patients had a clinical response, 68.2% and 53.0% had endoscopic improvement, and 63.6% and 49.4% were in remission with tofacitinib 5 and 10\u00a0mg BID, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The HZ IR in East Asian patients was numerically higher <jats:italic>versus<\/jats:italic> the global study population; excluding HZ, tofacitinib safety and efficacy were consistent with the global study population.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jgh.15923","type":"journal-article","created":{"date-parts":[[2022,6,23]],"date-time":"2022-06-23T07:06:48Z","timestamp":1655968008000},"page":"1884-1892","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Safety and efficacy of long\u2010term tofacitinib treatment in East Asian patients with ulcerative colitis in OCTAVE Open"],"prefix":"10.1111","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2950-7660","authenticated-orcid":false,"given":"Katsuyoshi","family":"Matsuoka","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Internal Medicine Toho University Sakura Medical Center  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1178-3536","authenticated-orcid":false,"given":"Tadakazu","family":"Hisamatsu","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Kyorin University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9675-4557","authenticated-orcid":false,"given":"Hyo Jong","family":"Kim","sequence":"additional","affiliation":[{"name":"Center for Crohn's and Colitis Kyung Hee University College of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6647-6325","authenticated-orcid":false,"given":"Byong Duk","family":"Ye","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Inflammatory Bowel Disease Center, Asan Medical Center University of Ulsan College of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4609-1609","authenticated-orcid":false,"given":"Shoko","family":"Arai","sequence":"additional","affiliation":[{"name":"Pfizer Japan Inc  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2874-1807","authenticated-orcid":false,"given":"Masato","family":"Hoshi","sequence":"additional","affiliation":[{"name":"Pfizer Japan Inc  Tokyo 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Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joon\u2010suk","family":"Woo","sequence":"additional","affiliation":[{"name":"Pfizer Korea Inc  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6256-1204","authenticated-orcid":false,"given":"Toshifumi","family":"Hibi","sequence":"additional","affiliation":[{"name":"Center for Advanced IBD Research and Treatment Kitasato University Kitasato Institute Hospital  Tokyo 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