{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:48:24Z","timestamp":1782780504537,"version":"3.54.5"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"8","license":[{"start":{"date-parts":[[2025,4,21]],"date-time":"2025-04-21T00:00:00Z","timestamp":1745193600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,4,21]],"date-time":"2025-04-21T00:00:00Z","timestamp":1745193600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/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":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Gastroenterol"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>We present the final analysis of a tofacitinib post-marketing surveillance (PMS) study in Japanese patients with ulcerative colitis (UC).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>Safety\/effectiveness data were evaluated (through Sept\/30\/2022). All\u00a0patients with UC in Japan receiving tofacitinib were registered (60-week observation period). Adverse events (AEs) were recorded. Per protocol, several AEs were identified as clinically important\/potential risks; all treatment-period data were used to calculate incidence rates (IRs; unique patients with events\/100 patient-years [PY] of exposure). Effectiveness was assessed (partial\/total Mayo score), with last observation carried forward for imputation of missing data.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Overall, 2043 patients were enrolled (safety analysis set: <jats:italic>n<\/jats:italic>\u2009=\u20091982\/effectiveness analysis set: <jats:italic>n<\/jats:italic>\u2009=\u20091969). Data were excluded for 13 patients from two hospitals from which consent was not obtained for publication and which, therefore, were not permitted for publication. AEs and serious AEs were observed in 33.4% and 5.2% of patients, respectively; one death occurred (intestinal abscess). Herpes zoster (HZ; non-serious and serious) was the most reported infection (<jats:italic>n<\/jats:italic>\u2009=\u200992 [IR\u00a05.93\/100 PY, 95%\u00a0confidence interval 4.78, 7.27]). Serious infection, malignancy, cardiovascular and venous thromboembolic events IRs were 1.51\/100 PY, 0.62\/100\u00a0PY, 0.13\/100 PY, and 0.31\/100\u00a0PY, respectively. Overall, 52.4% of patients discontinued treatment, mostly due to inadequate clinical response (48.9%). At\u00a0Week\u00a060, 1151\/1969 patients (58.5%) achieved partial Mayo score remission.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>The overall safety profile was generally comparable with tofacitinib data from PMS reports from Japan, worldwide and the tofacitinib UC clinical program. However, HZ IR was higher than in the tofacitinib UC clinical program. Tofacitinib effectiveness was consistent with data from the tofacitinib UC clinical program.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>ClinicalTrials.gov<\/jats:title>\n            <jats:p>NCT03643211.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00535-025-02249-5","type":"journal-article","created":{"date-parts":[[2025,4,21]],"date-time":"2025-04-21T12:15:37Z","timestamp":1745237737000},"page":"979-989","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data"],"prefix":"10.1007","volume":"60","clinical-trial-number":[{"clinical-trial-number":"nct03643211","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Katsuyoshi","family":"Matsuoka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Motoya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minoru","family":"Matsuura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshimitsu","family":"Fujii","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichiro","family":"Shinzaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yohei","family":"Mikami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4609-1609","authenticated-orcid":false,"given":"Shoko","family":"Arai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junichi","family":"Oshima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Endo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirotoshi","family":"Yuasa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masato","family":"Hoshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiko","family":"Sato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadakazu","family":"Hisamatsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,4,21]]},"reference":[{"key":"2249_CR1","doi-asserted-by":"publisher","first-page":"1756","DOI":"10.1016\/S0140-6736(16)32126-2","volume":"389","author":"R Ungaro","year":"2017","unstructured":"Ungaro R, Mehandru S, Allen PB, et al. 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S.M. has received research grants from AbbVie, Ajinomoto, AstraZeneca, Janssen, and Pfizer Inc, and speaker\u2019s bureau from Mitsubishi Tanabe. T.Y. has received lecture fees from AbbVie, Celltrion, EA Pharma, Gilead Sciences, Janssen, JIMRO, Kissei, Kyorin, Mitsubishi Tanabe, Mochida, Nippon Kayaku, Pfizer Inc, and Takeda. M.M. has received lecture fees from AbbVie and Janssen. T.F. has received research grants from AbbVie, Alfresa, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, EA Pharma, Eisai, Eli Lilly, Gilead Sciences, Janssen, Kissei, Mebix, Sanofi, and Takeda, and speaking fees from AbbVie, Ajinomoto Pharma, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, EA Pharma, Eisai, Janssen, Kissei, Kyorin, Kyowa Hakko Kirin, Mitsubishi Tanabe, Mochida, Nichi-Iko, Nippon Kayaku, Pfizer Inc, Taiho, Takeda, and Zeria. S.S. has received grants from AbbVie, EA Pharma, JIMRO, Kyorin, Mochida, Nippon Kayaku, and Zeria, consulting fees from AbbVie, EA Pharma, Eli Lilly, Gilead Sciences, Janssen, Kissei, Sekisui Medical, and Takeda, and lecture fees from AbbVie, EA Pharma, Gilead Sciences, Janssen, JIMRO, Kissei, Kyorin, Mitsubishi Tanabe, Mochida, Nippon Kayaku, Pfizer Inc, Sekisui, and Takeda. Y.M. has no conflicts to disclose. S.A. is an employee and stockholder of Pfizer, Japan. J.O. is an employee of Pfizer R&D, Japan. Y.E. is an employee and stockholder of Pfizer R&D, Japan. H.Y. is an employee and stockholder of Pfizer R&D, Japan. M.H. is an employee and stockholder of Pfizer, Japan. K.S. is an employee of Pfizer R&D, Japan. T.H. has received grants from AbbVie, Boston Scientific, EA Pharma, JIMRO, Kissei, Kyorin, Mitsubishi Tanabe, Mochida, Nippon Kayaku, Pfizer Inc, Takeda, and Zeria, consulting fees from AbbVie, Bristol Myers Squibb, EA Pharma, Eli Lilly, Gilead Sciences, Janssen, Mitsubishi Tanabe, Nichi-Iko, and Pfizer Inc, and lecture fees from AbbVie, EA Pharma, Janssen, JIMRO, Kissei, Kyorin, Mitsubishi Tanabe, Mochida, Pfizer Inc, and Takeda.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}