{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T21:29:12Z","timestamp":1770240552938,"version":"3.49.0"},"reference-count":39,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,8,19]],"date-time":"2024-08-19T00:00:00Z","timestamp":1724025600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,8,19]],"date-time":"2024-08-19T00:00:00Z","timestamp":1724025600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Pfizer Korea"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We aimed to identify the safety and effectiveness of tofacitinib in patients with UC in routine clinical settings in Korea.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This open-label, observational, prospective, post-marketing surveillance study was conducted at 22 hospitals in the Republic of Korea. Patients with moderate to severe active UC who received tofacitinib were included and followed up for up to 52 weeks. Tofacitinib was administered at a dosage of 10\u00a0mg twice daily for at least 8 weeks, followed by 5 or 10\u00a0mg twice daily at the investigator\u2019s discretion based on clinical evaluation according to the approved Korean label. Safety including adverse events (AEs) and effectiveness including clinical remission, clinical response, and endoscopic mucosal healing were evaluated. Safety analysis set was defined as all patients registered for this study who received at least one dose of tofacitinib according to the approved Korean label and followed up for safety data. Effectiveness analysis set included patients in the safety analysis set who were evaluated for overall effectiveness assessment and excluded patients who had received tofacitinib less than 8 weeks.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 110 patients were enrolled, of whom 106 patients were included in the safety population. The median duration of treatment was 370 days and the treatment duration ranged from 16 to 684 days for the safety population. AEs occurred in 42 patients (39.6%). Serious AEs (SAEs) occurred in 7 patients (6.6%) and of them, there were 2 cases of serious infections. These serious infections were reported as Adverse Event of Special Interest (AESI) in this study and no other AESI were reported. There were no cases of death during the study period. Clinical remission rates were 40.0%, 46.7%, 57.6%, and 55.1% at 8, 16, 24, and 52 weeks, and clinical response rates were 77.8%, 87.9%, 56.6%, and 81.4% at each visit, respectively. Endoscopic mucosal healing rates were 58.7% at 16 weeks and 46.2% at 52 weeks.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Tofacitinib was effective in Korean patients with moderate to severe active UC and the safety findings were consistent with the known safety profile of tofacitinib.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Summary<\/jats:title>\n                <jats:p>This study confirmed the safety and effectiveness of tofacitinib in Korean patients with moderate to severe active UC in routine clinical settings.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>This study is registered in the ClinicalTrials.gov under the identifier NCT04071405, registered on 28 August 2019.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12876-024-03336-2","type":"journal-article","created":{"date-parts":[[2024,8,19]],"date-time":"2024-08-19T08:02:16Z","timestamp":1724054536000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study"],"prefix":"10.1186","volume":"24","author":[{"given":"Hyuk","family":"Yoon","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Byong Duk","family":"Ye","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang-Bum","family":"Kang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kang-Moon","family":"Lee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chang Hwan","family":"Choi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joo-young","family":"Jo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juwon","family":"Woo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jae Hee","family":"Cheon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,8,19]]},"reference":[{"issue":"10080","key":"3336_CR1","first-page":"1756","volume":"389","author":"R Ungaro","year":"2017","unstructured":"Ungaro R, Mehandru S, Allen PB, et al. 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This study was conducted in accordance with the Declaration of Helsinki and followed generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practice (GPP) issued by the International Society for Pharmacoepidemiology (ISPE), Pharmaceutical Research and Manufacturers Association (PhRMA) guidelines, and local regulations\/guidelines for PMS. This study was approved by the Ministry of Food and Drug Safety (MFDS) and a total of 22 institutional review boards (IRBs) prior to data collection. The full name of each IRB was as follows. Samsung Medical Center IRB. Chung-Ang University Hospital IRB. Severance Hospital IRB. Seoul National University Hospital IRB. The Catholic University of Korea, Seoul ST. Mary\u2019s Hospital IRB. Gangnam Severance Hospital IRB. The Catholic University of Korea, Daejeon ST. Mary\u2019s Hospital IRB. Korea University Ansan Hospital IRB. Yeungnam University Medical Center IRB. Pusan National University Hospital IRB. Seoul National University Bundang Hospital IRB. The Catholic University of Korea, ST. Vincent\u2019s Hospital IRB. Kosin University Gospel Hospital IRB. Pusan National University Yangsan Hospital IRB. Hanyang University Guri Hospital IRB. Keimyung University Dongsan Medical Center IRB. The Catholic University of Korea, Bucheon ST.Mary\u2019s Hospital IRB. Asan Medical Center IRB. Wonju Severance Christian Hospital IRB. CHA University Bundang Medical Center IRB. Soon Chun Hyang University Hospital Seoul IRB. Soon Chun Hyang University Hospital Cheonan IRB.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors do not have an actual or potential conflict of interest and do not have any interest to declare regarding this work. Joo-young Jo and Juwon Woo are employed by Pfizer Pharmaceuticals Korea Ltd. All the other authors have no competing interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"273"}}