{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,8]],"date-time":"2026-11-08T00:00:13Z","timestamp":1794096013297,"version":"4.8.0"},"reference-count":46,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2022,9,17]],"date-time":"2022-09-17T00:00:00Z","timestamp":1663372800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/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":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,4,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Tofacitinib is an oral small molecule Janus kinase [JAK] inhibitor for the treatment of ulcerative colitis. We report an integrated summary of tofacitinib safety [exposure: \u22647.8 years] from the global clinical programme.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients receiving tofacitinib 5 or 10 mg twice daily [BID] from completed phase [P]2\/3 placebo-controlled studies, an open-label, long-term extension study [final data cut-off: August 24, 2020], and interim analysis of a P3b\/4 study (interim data cut-off: February 20, 2020; Overall plus P3b\/4 [2020] Cohort) were included. Proportions with adverse events [AEs] and serious AEs, and incidence rates [IRs; unique patients with events\/100 patient-years] for deaths and AEs of special interest [AESI] were evaluated. Opportunistic infections, malignancies, major adverse cardiovascular events [MACE] and gastrointestinal perforations were adjudicated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 1157 patients received one or more dose of tofacitinib (mean duration: 946.9 days); 955\/1157 [83%] received a predominant dose of 10 mg BID; 412\/1157 [35.6%] received tofacitinib for &amp;gt;4 years; 992\/1157 [85.7%] had AEs, 244\/1157 [21.1%] had serious AEs and 134\/1157 (11.6%) discontinued use due to AEs. IRs [95% confidence intervals] for all tofacitinib doses were: deaths, 0.23 [0.09\u20130.46]; serious infections, 1.69 [1.26\u20132.21]; herpes zoster [non-serious and serious], 3.30 [2.67\u20134.04]; opportunistic infections, 1.03 [0.70\u20131.46]; malignancies (excluding non-melanoma skin cancer [NMSC]), 0.84 [0.55\u20131.24]; NMSC, 0.73 [0.45\u20131.10]; MACE, 0.29 [0.13\u20130.55]; deep vein thrombosis, 0.03 [0.00\u20130.18]; pulmonary embolism, 0.19 [0.07\u20130.42]; gastrointestinal perforations, 0.10 [0.02\u20130.28].<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>AESI IRs were stable to 7.8 years and generally &amp;lt;2.0 in the Overall plus P3b\/4 [2020] Cohort, with the exception of herpes zoster [a known risk of tofacitinib treatment]. ClinicalTrials.gov:NCT00787202;NCT01465763;NCT01458951;NCT01458574;NCT01470612;NCT03281304<\/jats:p>\n                    <jats:p>JCC Topic\/keyword selection: 3. Clinical trials<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjac141","type":"journal-article","created":{"date-parts":[[2022,9,15]],"date-time":"2022-09-15T16:50:39Z","timestamp":1663260639000},"page":"338-351","source":"Crossref","is-referenced-by-count":79,"title":["Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme"],"prefix":"10.1093","volume":"17","author":[{"given":"William J","family":"Sandborn","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, University of California San Diego , La Jolla, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geert R","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Amsterdam University Medical Centres , Amsterdam , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Dr. Henry D. 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USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Modesto","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiang","family":"Guo","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajiv","family":"Mundayat","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chinyu","family":"Su","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivana","family":"Vranic","sequence":"additional","affiliation":[{"name":"Pfizer Ltd , Tadworth, Surrey , 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