{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T11:40:21Z","timestamp":1782301221833,"version":"3.54.5"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2024,1,20]],"date-time":"2024-01-20T00:00:00Z","timestamp":1705708800000},"content-version":"vor","delay-in-days":19,"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":[[2024,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). This analysis assessed the impact of cigarette smoking on tofacitinib efficacy and safety in the UC clinical program.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Efficacy endpoints and adverse events (AEs) were evaluated by smoking status (ever smokers [current and ex-smokers] and never smokers) in the phase (P)2 induction study (baseline demographics and safety only), P3 studies (OCTAVE Induction 1&amp;2, OCTAVE Sustain, OCTAVE Open), and P3\/4b RIVETING study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>This post hoc analysis included 1156 patients (ever smokers, n\u2005=\u2005416 [36.0%; current smokers, n\u2005=\u200559 (5.1%); ex-smokers, n\u2005=\u2005357 (30.9%)]; never smokers, n\u2005=\u2005740 [64.0%]; median [range] treatment duration 654 [1\u20132712] and 615.5 [1\u20132850] days, respectively). Similar proportions of ever smokers and never smokers achieved efficacy endpoints. AEs were reported in 88.7% of ever smokers and 83.8% of never smokers. Overall, 60.6% of ever smokers had an infection (serious infections, 5.5%; herpes zoster [nonserious and serious], 10.8%; Clostridioides difficile infection, 12.0%; lower respiratory tract infection, 19.5%: corresponding values among never smokers were 53.1%, 3.9%, 6.8%, 8.5%, and 11.4%). Major adverse cardiovascular events were reported in 1.0% of ever smokers and 0.7% of never smokers and thromboembolism events (venous and arterial) in 1.0% of ever smokers and 0.9% never smokers. Deaths, malignancies (excluding non-melanoma skin cancer [NMSC]), and NMSC occurred infrequently in ever smokers (0.5%, 2.5%, and 3.7%, respectively) and never smokers (0.1%, 1.5%, and 1.0%, respectively). Colorectal cancer was reported in 0.6% of never smokers; no cases occurred in ever smokers.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Efficacy and safety of tofacitinib were generally similar in ever smokers and never smokers. Overall, serious AEs and, as expected, infections were more frequent in ever smokers versus never smokers. This may inform treatment selection and monitoring strategies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>ClinicalTrials.gov<\/jats:title>\n                  <jats:p>NCT00787202;NCT01465763;NCT01458951;NCT01458574;NCT01470612;NCT03281304<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/crocol\/otae004","type":"journal-article","created":{"date-parts":[[2024,1,21]],"date-time":"2024-01-21T05:34:25Z","timestamp":1705815265000},"source":"Crossref","is-referenced-by-count":5,"title":["Association Between Smoking Status and the Efficacy and Safety of Tofacitinib in Patients with Ulcerative Colitis"],"prefix":"10.1093","volume":"6","author":[{"given":"David T","family":"Rubin","sequence":"first","affiliation":[{"name":"Inflammatory Bowel Disease Center, University of Chicago Medicine , Chicago, IL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2895-5821","authenticated-orcid":false,"given":"Joana","family":"Torres","sequence":"additional","affiliation":[{"name":"Gastroenterology Division, Hospital Beatriz \u00c2ngelo , Loures , Portugal"},{"name":"Division of Gastroenterology, Hospital da Luz , Lisbon , Portugal"},{"name":"Faculdade de Medicina, Universidade de Lisboa , Lisbon , Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7681-8111","authenticated-orcid":false,"given":"Miguel","family":"Regueiro","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic , Cleveland, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2088-091X","authenticated-orcid":false,"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine III, Medical University of Vienna , Vienna , Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lani","family":"Prideaux","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Monash Medical Centre , Melbourne, Victoria , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paulo G","family":"Kotze","sequence":"additional","affiliation":[{"name":"IBD Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paran\u00e1 , Curitiba , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1599-0997","authenticated-orcid":false,"given":"Fiona H","family":"Tan","sequence":"additional","affiliation":[{"name":"Pfizer Australia , Melbourne, Victoria , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-9193-9844","authenticated-orcid":false,"given":"Sean","family":"Gardiner","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York, NY , 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":"Mary Jane","family":"Cadatal","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Manila , Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siew C","family":"Ng","sequence":"additional","affiliation":[{"name":"Department of Medicine and Therapeutics, Institute of Digestive Disease, LKS Institute of Health Science, Chinese University of Hong Kong , Sha Tin, Hong Kong , China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,1,20]]},"reference":[{"key":"2024022921465687300_CIT0001","doi-asserted-by":"crossref","first-page":"113","DOI":"10.25122\/jml-2018-0075","article-title":"A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease","volume":"12(2","author":"Seyedian","year":"2019","journal-title":"J Med Life"},{"issue":"46","key":"2024022921465687300_CIT0002","doi-asserted-by":"crossref","first-page":"6134","DOI":"10.3748\/wjg.v13.i46.6134","article-title":"Smoking in inflammatory bowel diseases: good, bad or ugly","volume":"13","author":"Lakatos","year":"2007","journal-title":"World J Gastroenterol."},{"issue":"11-12","key":"2024022921465687300_CIT0003","doi-asserted-by":"crossref","first-page":"997","DOI":"10.1111\/apt.12086","article-title":"Review article: ulcerative colitis, smoking and nicotine therapy","volume":"36","author":"Lunney","year":"2012","journal-title":"Aliment Pharmacol Ther."},{"issue":"2","key":"2024022921465687300_CIT0004","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1016\/j.thorsurg.2013.01.009","article-title":"Tobacco smoking: the leading cause of preventable disease worldwide","volume":"23","author":"Samet","year":"2013","journal-title":"Thorac Surg Clin."},{"issue":"Suppl 3","key":"2024022921465687300_CIT0005","doi-asserted-by":"crossref","first-page":"s1","DOI":"10.1136\/gutjnl-2019-318484","article-title":"British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults","volume":"68","author":"Lamb","year":"2019","journal-title":"Gut."},{"issue":"4","key":"2024022921465687300_CIT0006","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1093\/ecco-jcc\/jjv238","article-title":"Smoking is associated with extra-intestinal manifestations in inflammatory bowel disease","volume":"10","author":"Severs","year":"2016","journal-title":"J Crohns Colitis"},{"issue":"8","key":"2024022921465687300_CIT0007","doi-asserted-by":"crossref","first-page":"1533","DOI":"10.1016\/j.cgh.2018.09.035","article-title":"Retrospective analysis of safety of vedolizumab in patients with inflammatory bowel diseases","volume":"17","author":"Meserve","year":"2019","journal-title":"Clin Gastroenterol Hepatol."},{"issue":"32","key":"2024022921465687300_CIT0008","doi-asserted-by":"crossref","first-page":"e21686","DOI":"10.1097\/MD.0000000000021686","article-title":"Risk factors for ulcerative colitis-associated colorectal cancer: a retrospective cohort study","volume":"99","author":"de Campos Silva","year":"2020","journal-title":"Medicine (Baltimore)."},{"issue":"9","key":"2024022921465687300_CIT0009","doi-asserted-by":"crossref","first-page":"717","DOI":"10.1016\/j.crohns.2012.10.004","article-title":"Observational study on the efficacy of adalimumab for the treatment of ulcerative colitis and predictors of outcome","volume":"7","author":"Garc\u00eda-Bosch","year":"2013","journal-title":"J Crohns Colitis"},{"issue":"4","key":"2024022921465687300_CIT0010","doi-asserted-by":"crossref","first-page":"519","DOI":"10.1111\/apt.13893","article-title":"Long-term outcome of infliximab treatment in chronic active ulcerative colitis: a Swedish multicentre study of 250 patients","volume":"45","author":"Angelison","year":"2017","journal-title":"Aliment Pharmacol Ther."},{"issue":"12","key":"2024022921465687300_CIT0011","doi-asserted-by":"crossref","first-page":"2879","DOI":"10.1097\/MIB.0000000000000561","article-title":"Efficacy of vedolizumab as induction therapy in refractory IBD patients: a multicenter cohort","volume":"21","author":"Shelton","year":"2015","journal-title":"Inflamm Bowel Dis."},{"issue":"2","key":"2024022921465687300_CIT0012","doi-asserted-by":"crossref","first-page":"385","DOI":"10.1007\/s11845-017-1666-0","article-title":"Severe ulcerative colitis: predictors of response and algorithm proposal for rescue therapy","volume":"187","author":"Ribaldone","year":"2018","journal-title":"Ir J Med Sci."},{"issue":"7","key":"2024022921465687300_CIT0013","doi-asserted-by":"crossref","first-page":"756","DOI":"10.1016\/j.crohns.2011.12.010","article-title":"Low-dose smoking resumption in ex-smokers with refractory ulcerative colitis","volume":"6","author":"Calabrese","year":"2012","journal-title":"J Crohns Colitis"},{"issue":"7","key":"2024022921465687300_CIT0014","doi-asserted-by":"crossref","first-page":"616","DOI":"10.1056\/NEJMoa1112168","article-title":"Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis","volume":"367","author":"Sandborn","year":"2012","journal-title":"N Engl J Med."},{"issue":"18","key":"2024022921465687300_CIT0015","doi-asserted-by":"crossref","first-page":"1723","DOI":"10.1056\/NEJMoa1606910","article-title":"Tofacitinib as induction and maintenance therapy for ulcerative colitis","volume":"376","author":"Sandborn","year":"2017","journal-title":"N Engl J Med."},{"issue":"4","key":"2024022921465687300_CIT0016","doi-asserted-by":"crossref","first-page":"464","DOI":"10.1111\/apt.16712","article-title":"Safety and efficacy of tofacitinib for treatment of ulcerative colitis: final analysis of OCTAVE Open, an open-label, long-term extension study with up to 7.0 years of treatment","volume":"55","author":"Sandborn","year":"2022","journal-title":"Aliment Pharmacol Ther."},{"issue":"7","key":"2024022921465687300_CIT0017","doi-asserted-by":"crossref","first-page":"1130","DOI":"10.1093\/ecco-jcc\/jjaa249","article-title":"Outcomes of tofacitinib dose reduction in patients with ulcerative colitis in stable remission from the randomised RIVETING trial","volume":"15","author":"Vermeire","year":"2021","journal-title":"J Crohns Colitis"},{"issue":"3","key":"2024022921465687300_CIT0018","doi-asserted-by":"crossref","first-page":"338","DOI":"10.1093\/ecco-jcc\/jjac141","article-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","volume":"17","author":"Sandborn","year":"2023","journal-title":"J Crohns Colitis"},{"issue":"5","key":"2024022921465687300_CIT0019","doi-asserted-by":"crossref","first-page":"694","DOI":"10.1093\/ecco-jcc\/jjz195","article-title":"Predictors of primary response to biologic treatment [anti-TNF, vedolizumab, and ustekinumab] in patients with inflammatory bowel disease: from basic science to clinical practice","volume":"14","author":"Gisbert","year":"2020","journal-title":"J Crohns Colitis"},{"issue":"10","key":"2024022921465687300_CIT0020","doi-asserted-by":"crossref","first-page":"1090","DOI":"10.1111\/apt.13594","article-title":"Vedolizumab induction therapy for inflammatory bowel disease in clinical practice\u2014a nationwide consecutive German cohort study","volume":"43","author":"Baumgart","year":"2016","journal-title":"Aliment Pharmacol Ther."},{"issue":"20","key":"2024022921465687300_CIT0021","doi-asserted-by":"crossref","first-page":"2206","DOI":"10.1001\/archinte.164.20.2206","article-title":"Cigarette smoking and infection","volume":"164","author":"Arcavi","year":"2004","journal-title":"Arch Intern Med."},{"issue":"10","key":"2024022921465687300_CIT0022","doi-asserted-by":"crossref","first-page":"2258","DOI":"10.1093\/ibd\/izy131","article-title":"Herpes zoster infection in patients with ulcerative colitis receiving tofacitinib","volume":"24","author":"Winthrop","year":"2018","journal-title":"Inflamm Bowel Dis."},{"issue":"6","key":"2024022921465687300_CIT0023","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1016\/j.crohns.2013.12.013","article-title":"Second European evidence-based consensus on the prevention, diagnosis and management of opportunistic infections in inflammatory bowel disease","volume":"8","author":"Rahier","year":"2014","journal-title":"J Crohns Colitis"},{"issue":"6","key":"2024022921465687300_CIT0024","doi-asserted-by":"crossref","first-page":"879","DOI":"10.1093\/ecco-jcc\/jjab052","article-title":"ECCO guidelines on the prevention, diagnosis, and management of infections in inflammatory bowel disease","volume":"15","author":"Kucharzik","year":"2021","journal-title":"J Crohns Colitis"},{"issue":"7","key":"2024022921465687300_CIT0025","doi-asserted-by":"crossref","first-page":"e42091","DOI":"10.1371\/journal.pone.0042091","article-title":"Higher rates of Clostridium difficile infection among smokers","volume":"7","author":"Rogers","year":"2012","journal-title":"PLoS One."},{"issue":"9589","key":"2024022921465687300_CIT0026","doi-asserted-by":"crossref","first-page":"765","DOI":"10.1016\/S0140-6736(07)61380-4","article-title":"Global burden of COPD: risk factors, prevalence, and future trends","volume":"370","author":"Mannino","year":"2007","journal-title":"Lancet."},{"issue":"4","key":"2024022921465687300_CIT0027","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1186\/ar2751","article-title":"Rheumatoid arthritis and smoking: putting the pieces together","volume":"11","author":"Baka","year":"2009","journal-title":"Arthritis Res Ther."},{"issue":"1","key":"2024022921465687300_CIT0028","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1002\/ijc.23033","article-title":"Tobacco smoking and cancer: a meta-analysis","volume":"122","author":"Gandini","year":"2008","journal-title":"Int J Cancer."},{"issue":"6","key":"2024022921465687300_CIT0029","doi-asserted-by":"crossref","first-page":"816","DOI":"10.1093\/ibd\/izaa199","article-title":"Tofacitinib, an oral Janus kinase inhibitor: analysis of malignancy (excluding nonmelanoma skin cancer) events across the ulcerative colitis clinical program","volume":"27","author":"Lichtenstein","year":"2021","journal-title":"Inflamm Bowel Dis."},{"issue":"10","key":"2024022921465687300_CIT0030","doi-asserted-by":"crossref","first-page":"1068","DOI":"10.1111\/apt.15514","article-title":"Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme","volume":"50","author":"Sandborn","year":"2019","journal-title":"Aliment Pharmacol Ther."},{"issue":"6","key":"2024022921465687300_CIT0031","doi-asserted-by":"crossref","first-page":"797","DOI":"10.1093\/ibd\/izaa227","article-title":"Lipid profiles in patients with ulcerative colitis receiving tofacitinib-implications for cardiovascular risk and patient management","volume":"27","author":"Sands","year":"2021","journal-title":"Inflamm Bowel Dis."},{"issue":"4","key":"2024022921465687300_CIT0032","first-page":"235","article-title":"Extraintestinal manifestations of inflammatory bowel disease","volume":"7","author":"Levine","year":"2011","journal-title":"Gastroenterol Hepatol (N Y)"}],"container-title":["Crohn's &amp; Colitis 360"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/advance-article-pdf\/doi\/10.1093\/crocol\/otae004\/56319753\/otae004.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/6\/1\/otae004\/56800117\/otae004.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/6\/1\/otae004\/56800117\/otae004.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,29]],"date-time":"2024-02-29T21:47:24Z","timestamp":1709243244000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article\/doi\/10.1093\/crocol\/otae004\/7584713"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,1]]},"references-count":32,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,1,1]]}},"URL":"https:\/\/doi.org\/10.1093\/crocol\/otae004","relation":{},"ISSN":["2631-827X"],"issn-type":[{"value":"2631-827X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,1,1]]},"published":{"date-parts":[[2024,1,1]]},"article-number":"otae004"}}