{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T22:03:41Z","timestamp":1790805821699,"version":"4.1.0"},"reference-count":26,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,5,22]],"date-time":"2024-05-22T00:00:00Z","timestamp":1716336000000},"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":[],"crossmark-restriction":false},"short-container-title":["UEG Journal"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Aims<\/jats:title><jats:p>Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We report an integrated summary of tofacitinib safety from the completed global UC clinical program (9.2\u00a0years maximum tofacitinib exposure).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This analysis included patients receiving tofacitinib 5 or 10\u00a0mg twice daily (b.i.d.) from completed phase 2\/3 placebo\u2010controlled studies, an open\u2010label, long\u2010term extension study and a randomized phase 3b\/4 study. Proportions and incidence rates (IRs; unique patients with events\/100 patient\u2010years [PY] of exposure) were evaluated for deaths and adverse events (AEs) of special interest (AESI).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 1157 patients received \u22651 dose of tofacitinib 5 or 10\u00a0mg b.i.d.; 938\u00a0(81.1%) were in the predominant dose tofacitinib 10\u00a0mg\u00a0b.i.d. group; 552 (47.7%) received tofacitinib for \u22652\u00a0years; total exposure: 3202.0 PY; 994 (85.9%) experienced AEs; 254 (22.0%) experienced serious AEs. Median treatment duration: 1.7 (range 0.0\u20139.2) years. IRs (95% CI) for combined tofacitinib doses: deaths 0.24 (0.10\u20130.48); serious infections (SIs) 1.80 (1.37\u20132.32); herpes zoster (HZ; non\u2010serious and serious) 3.24 (2.63\u20133.94); serious HZ 0.24 (0.10\u20130.48); opportunistic infections 0.96 (0.65\u20131.36); malignancies (excluding non\u2010melanoma skin cancer [NMSC]) 0.88 (0.59\u20131.26); NMSC 0.71 (0.45\u20131.07); major adverse cardiovascular events 0.27 (0.12\u20130.52); deep vein thrombosis 0.06 (0.01\u20130.22); pulmonary embolism 0.18 (0.07\u20130.40); and gastrointestinal perforations 0.09 (0.02\u20130.27).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Except for HZ and SIs, IRs for AESI were &lt;1 case\/100 PY. Safety was consistent with previous analyses of shorter exposure and tofacitinib's known safety profile, including real\u2010world data.<\/jats:p><\/jats:sec><jats:sec><jats:title>ClinicalTrials.gov<\/jats:title><jats:p>NCT00787202; NCT01465763; NCT01458951; NCT01458574; NCT01470612; NCT03281304.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ueg2.12584","type":"journal-article","created":{"date-parts":[[2024,5,23]],"date-time":"2024-05-23T05:39:25Z","timestamp":1716442765000},"page":"793-801","source":"Crossref","is-referenced-by-count":36,"title":["Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2\u00a0years of drug exposure"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4971-6902","authenticated-orcid":false,"given":"Julian","family":"Pan\u00e9s","sequence":"first","affiliation":[{"name":"Department of Gastroenterology Hospital Cl\u00ednic de Barcelona IDIBAPS CIBERehd  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geert R.","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Amsterdam University Medical Centers  Amsterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E.","family":"Sands","sequence":"additional","affiliation":[{"name":"Dr Henry D. 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