{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T13:52:01Z","timestamp":1778161921295,"version":"3.51.4"},"reference-count":24,"publisher":"Korean Association for the Study of Intestinal Diseases","issue":"2","license":[{"start":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T00:00:00Z","timestamp":1762732800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/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":["irjournal.org"],"crossmark-restriction":true},"short-container-title":["Intest Res"],"published-print":{"date-parts":[[2026,4,30]]},"abstract":"<jats:p>Background\/Aims: To assess, &lt;i&gt;post hoc&lt;\/i&gt;, tofacitinib safety\/effectiveness in patients with ulcerative colitis (UC), stratified by age, using data from a 60-week post-marketing surveillance (PMS) study in Japan.Methods: All patients with UC receiving tofacitinib in Japan were enrolled in a large PMS study. Incidence proportions of adverse events (AEs), incidence rates (IRs; unique patients with events\/100 patient-years of exposure) of clinically important AEs, reasons for discontinuation, and partial Mayo score clinical remission, stratified by age ( \u2265 65 and &lt; 65 years), were evaluated.Results: The analysis included 212 older ( \u2265 65 years) and 1,770 younger ( &lt; 65 years) patients. Demographics and baseline disease characteristics were generally similar between groups; however, more older versus younger patients had cardiovascular disease (23.1% vs. 4.6%). Incidence proportions of AEs were comparable between groups, but IRs (95% confidence intervals) in older versus younger patients were numerically higher for herpes zoster (9.81 [5.72\u201315.71] vs. 5.44 [4.28\u20136.82]), and higher for serious infections (4.45 [1.92\u20138.76] vs. 1.14 [0.65\u20131.85]). More older versus younger patients discontinued due to AEs (28.6% vs. 17.6%); more younger versus older patients discontinued due to insufficient clinical responses (50.3% vs. 35.2%). Clinical remission rates through 60 weeks were generally similar between groups.Conclusions: Older patients had higher IRs of herpes zoster and serious infection than younger patients, although tofacitinib effectiveness was similar between age groups. Discontinuation due to AEs was more common in older patients. Despite the smaller sample size of older versus younger patients, a focused evaluation of older patients is of benefit.<\/jats:p>","DOI":"10.5217\/ir.2025.00058","type":"journal-article","created":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T07:55:09Z","timestamp":1762761309000},"page":"214-224","update-policy":"https:\/\/doi.org\/10.5217\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a &lt;i&gt;post hoc&lt;\/i&gt; analysis of safety and effectiveness in older (\u226565 years) and younger (&lt;65 years) patients"],"prefix":"10.5217","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2950-7660","authenticated-orcid":true,"given":"Katsuyoshi","family":"Matsuoka","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7551-5568","authenticated-orcid":true,"given":"Takayuki","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Surgery and IBD Center, Yokkaichi Hazu Medical Center, Yokkaichi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9590-2370","authenticated-orcid":true,"given":"Minoru","family":"Matsuura","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Kyorin University, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3048-7270","authenticated-orcid":true,"given":"Toshimitsu","family":"Fujii","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Institute of Science Tokyo, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4609-1609","authenticated-orcid":true,"given":"Shoko","family":"Arai","sequence":"additional","affiliation":[{"name":"Pfizer Japan Inc, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2006-7707","authenticated-orcid":true,"given":"Yutaka","family":"Endo","sequence":"additional","affiliation":[{"name":"Pfizer R&D Japan, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-1270-6725","authenticated-orcid":true,"given":"Keiko","family":"Sato","sequence":"additional","affiliation":[{"name":"Pfizer R&D Japan, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2067-7392","authenticated-orcid":true,"given":"Hirotoshi","family":"Yuasa","sequence":"additional","affiliation":[{"name":"Pfizer R&D Japan, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-7852-9046","authenticated-orcid":true,"given":"Yasushi","family":"Mizuno","sequence":"additional","affiliation":[{"name":"Pfizer Japan Inc, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-5048-4479","authenticated-orcid":true,"given":"Yuki","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Pfizer Japan Inc, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1178-3536","authenticated-orcid":true,"given":"Tadakazu","family":"Hisamatsu","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Kyorin University, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"3168","reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(16)32126-2"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1007\/s00384-023-04417-6"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-019-01580-y"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa1606910"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1159\/000502144"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2018.16.2.233"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1111\/apt.16712"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.15923"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-025-02249-5"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa2109927"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1136\/ard-2022-222259"},{"key":"ref12","first-page":"901","volume-title":"Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomized controlled study ORAL Surveillance","author":"Kristensen","year":"2023"},{"key":"ref13","volume-title":"Food and Drug Administration. 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