{"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":1794096013008,"version":"4.8.0"},"reference-count":59,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2020,11,27]],"date-time":"2020-11-27T00:00:00Z","timestamp":1606435200000},"content-version":"vor","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":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,6,22]]},"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 JAK inhibitor for the treatment of ulcerative colitis. We report integrated analyses of infections in the Phase [P]2 and P3 OCTAVE programmes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Three cohorts were analysed: Induction [P2\/3 induction studies]; Maintenance [P3 maintenance study]; and Overall [all tofacitinib-treated patients in induction, maintenance, or ongoing, open-label, long-term extension studies; as of May 2019]. Proportions and incidence rates [IRs; unique patients with events\/100 patient-years] of serious infections [SIs], herpes zoster [HZ] [non-serious and serious], and opportunistic infections [OIs] are reported [censored at time of event].<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the Induction Cohort [N\u2005=\u20051220], no patients receiving placebo and eight [0.9%] receiving tofacitinib 10 mg twice daily [BID] developed SIs. Maintenance Cohort [N\u2005=\u2005592] SI IRs (95% confidence interval [CI]) were 1.94 [0.23\u20137.00] for placebo and 1.35 [0.16\u20134.87] and 0.64 [0.02\u20133.54] for tofacitinib 5 and 10 mg BID, respectively; HZ IRs were 0.97 [0.02\u20135.42], 2.05 [0.42\u20136.00], and 6.64 [3.19\u201312.22], respectively. In the Overall Cohort [N\u2005=\u20051157; 82.9% predominantly received tofacitinib 10 mg BID], SI, HZ, and non-HZ OI IRs were 1.70 [1.24\u20132.27], 3.48 [2.79\u20134.30], and 0.15 [0.04\u20130.38], respectively. No SIs resulted in death.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>During induction, SIs were more frequent with tofacitinib versus placebo. SIs were generally infrequent in the Maintenance and Overall Cohorts, with rates comparable between treatment groups. Maintenance Cohort HZ IR was numerically higher with tofacitinib 10 mg BID versus 5 mg BID. Overall Cohort HZ IRs remained stable over time. Non-HZ OIs and viral infections were rare.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaa233","type":"journal-article","created":{"date-parts":[[2020,11,23]],"date-time":"2020-11-23T22:34:32Z","timestamp":1606170872000},"page":"914-929","source":"Crossref","is-referenced-by-count":36,"title":["Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical Programme"],"prefix":"10.1093","volume":"15","author":[{"given":"Kevin L","family":"Winthrop","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Oregon Health & Science University, Portland, OR, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Edward V","family":"Loftus","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel C","family":"Baumgart","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chudy I","family":"Nduaka","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nervin","family":"Lawendy","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Chan","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajiv","family":"Mundayat","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Pfizer Inc, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary S","family":"Friedman","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonardo","family":"Salese","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew J","family":"Thorpe","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chinyu","family":"Su","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Pfizer Inc, 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