{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T18:29:16Z","timestamp":1793212156891,"version":"4.5.0"},"reference-count":35,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T00:00:00Z","timestamp":1638316800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. We present final data from OCTAVE Open, an open\u2010label, long\u2010term extension study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>The primary objective of OCTAVE Open was to assess the safety and tolerability of long\u2010term tofacitinib in patients with ulcerative colitis; evaluating efficacy was a secondary objective.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Eligible patients included OCTAVE Induction 1&amp;2 non\u2010responders and OCTAVE Sustain completers\/treatment failures. Patients in remission at OCTAVE Open baseline received tofacitinib 5\u00a0mg b.d.; all others received 10\u00a0mg b.d. Incidence rates (unique patients with events\/100 patient\u2010years) for adverse events of special interest were calculated; \u22647.0\u00a0years of observation. Efficacy endpoints derived from Mayo score were reported \u226436\u00a0months (last scheduled endoscopy visit).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In OCTAVE Open, 769 of 944 patients (81.5%) initially received tofacitinib 10\u00a0mg b.d. Among all patients (2440.8 patient\u2010years of exposure), incidence rates (IRs; 95% confidence intervals) for deaths and adverse events of special interest were: deaths, 0.25 (0.09\u20100.54); serious infections, 1.61 (1.14\u20102.20); herpes zoster (non\u2010serious and serious), 3.16 (2.47\u20103.97); opportunistic infections, 0.87 (0.54\u20101.33); major adverse cardiovascular events, 0.16 (0.04\u20100.42); malignancies (excluding non\u2010melanoma skin cancer), 1.03 (0.67\u20101.52); non\u2010melanoma skin cancer, 0.75 (0.45\u20101.19); deep vein thrombosis, 0.04 (0.00\u20100.23); pulmonary embolism, 0.21 (0.07\u20100.48). At Month 36, 66.9% and 40.3% showed clinical response, 64.6% and 37.1% had endoscopic improvement, and 58.9% and 33.7% maintained or achieved remission, with tofacitinib 5 and 10\u00a0mg b.d. respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Tofacitinib demonstrated consistent safety up to 7.0\u00a0 years. Data collected up to Month 36 support long\u2010term efficacy beyond the 52\u2010week maintenance study.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.16712","type":"journal-article","created":{"date-parts":[[2021,12,2]],"date-time":"2021-12-02T08:23:09Z","timestamp":1638433389000},"page":"464-478","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":152,"title":["Safety and efficacy of tofacitinib for treatment of ulcerative colitis: final analysis of OCTAVE Open, an open\u2010label, long\u2010term extension study with up to 7.0\u00a0years of treatment"],"prefix":"10.1111","volume":"55","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":"Nervin","family":"Lawendy","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Collegeville PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Gastroenterology and Endoscopy IRCCS Ospedale San Raffaele and University Vita\u2010Salute San Raffaele  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chinyu","family":"Su","sequence":"additional","affiliation":[{"name":"Pfizer Inc  Collegeville PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7199-6851","authenticated-orcid":false,"suffix":"Jr.","given":"Edward\u00a0V.","family":"Loftus","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic College of Medicine  Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ailsa","family":"Hart","sequence":"additional","affiliation":[{"name":"IBD Unit St Mark\u2019s Hospital  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"Dotan","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology Rabin Medical Center  Petah Tikva Israel"},{"name":"Sackler Faculty of Medicine Tel Aviv University  Tel Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ad\u00e9rson O. 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