{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T05:26:15Z","timestamp":1790400375753,"version":"4.1.0"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2020,8,7]],"date-time":"2020-08-07T00:00:00Z","timestamp":1596758400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Pfizer Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,5,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Here, we performed an integrated analysis of malignancy events from the tofacitinib phase 3 UC clinical development program (excluding nonmelanoma skin cancer [NMSC]).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Data (up to May 2019) were pooled from two phase 3 induction studies, a phase 3 maintenance study, and an ongoing, open-label, long-term extension (OLE) study, and analyzed as 3 cohorts: induction (N = 1139), maintenance (N = 592), and overall (induction, maintenance, and ongoing OLE study; N = 1124). Proportions and incidence rates (IRs; unique patients with events per 100 patient-years [PY] of exposure) for malignancies confirmed by adjudication were calculated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The overall cohort consisted of patients who received at least 1 dose of tofacitinib at 5 or 10 mg twice daily, for up to 6.8 years, with an exposure of 2576.4 PY. Of the 1124 overall cohort tofacitinib-treated patients, 20 developed a malignancy (excluding NMSC; IR, 0.75; 95% confidence interval, 0.46\u20131.16), of which 17 occurred in patients treated with tofacitinib 10 mg twice daily; importantly, more than 80% of patients predominantly received this dose. Furthermore, there was no apparent clustering of malignancy types, and IRs were stable over time.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In the tofacitinib UC clinical development program, malignancy events were infrequent, and rates were comparable with those in the tofacitinib rheumatoid arthritis and psoriatic arthritis clinical development programs, and for biologic UC treatments. ClinicalTrials.gov: NCT01465763, NCT01458951, NCT01458574, and NCT01470612.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izaa199","type":"journal-article","created":{"date-parts":[[2020,8,7]],"date-time":"2020-08-07T13:53:27Z","timestamp":1596808407000},"page":"816-825","source":"Crossref","is-referenced-by-count":27,"title":["Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program"],"prefix":"10.1093","volume":"27","author":[{"given":"Gary R","family":"Lichtenstein","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, University of Pennsylvania School of Medicine , Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerhard","family":"Rogler","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University of Z\u00fcrich , Z\u00fcrich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew A","family":"Ciorba","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Washington University in Saint Louis , Saint Louis, Missouri, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chinyu","family":"Su","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Chan","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald D","family":"Pedersen","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nervin","family":"Lawendy","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Quirk","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chudy I","family":"Nduaka","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew J","family":"Thorpe","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julian","family":"Pan\u00e9s","sequence":"additional","affiliation":[{"name":"Hospital Cl\u00ednic de Barcelona, IDIBAPS , CIBERehd, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,8,7]]},"reference":[{"key":"2023112303241907500_CIT0001","doi-asserted-by":"crossref","first-page":"1756","DOI":"10.1016\/S0140-6736(16)32126-2","article-title":"Ulcerative colitis","volume":"389","author":"Ungaro","year":"2017","journal-title":"Lancet."},{"key":"2023112303241907500_CIT0002","doi-asserted-by":"crossref","first-page":"1423","DOI":"10.1002\/ibd.21484","article-title":"Nonmelanoma skin cancer in inflammatory bowel disease: a review","volume":"17","author":"Long","year":"2011","journal-title":"Inflamm Bowel Dis."},{"key":"2023112303241907500_CIT0003","doi-asserted-by":"crossref","first-page":"265","DOI":"10.1016\/j.cgh.2013.03.034","article-title":"Risk of cancer in patients with inflammatory bowel diseases: a nationwide population-based cohort study with 30 years of follow-up evaluation","volume":"12","author":"Kappelman","year":"2014","journal-title":"Clin 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