{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T19:24:19Z","timestamp":1788809059349,"version":"build-2803163510"},"reference-count":13,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2023,9,13]],"date-time":"2023-09-13T00:00:00Z","timestamp":1694563200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100003197","name":"Agenzia Italiana del Farmaco, Ministero della Salute","doi-asserted-by":"publisher","award":["H49E19000410005"],"award-info":[{"award-number":["H49E19000410005"]}],"id":[{"id":"10.13039\/501100003197","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background and Aims<\/jats:title>\n                  <jats:p>Older patients with ulcerative colitis treated with tofacitinib are at risk for major cardiovascular events, thromboembolism, herpes zoster, and malignancies and, accordingly, its use is limited by the regulatory authorities. The aim of the present study was to evaluate the occurrence of adverse events and potential preventive measures.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We retrospectively evaluated patients treated with tofacitinib, divided into two groups according to comorbidities and age. Patient- and disease-related variables were recorded [primary non-response, loss of response, and persistence], together with deviations from the recommended induction regimen, ie, dose reduction, and concomitant treatments with anti-thrombotic therapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The age-adjusted Charlson comorbidity index of Group 1 [n\u2005=\u200530] was\u2005\u22652 and that of Group 2 [n\u2005=\u200537] was \u2264\u20051. No differences were observed for primary or secondary treatment failures. Both groups achieved comparable steroid-free remission rates at 12 months [53% and 46%, respectively]. Herpes zoster occurred in two patients per group, and no more cases occurred after strict recombinant zoster vaccination. No major cardiovascular event or thromboembolism was registered. Half of patients in Group 1 were treated with a reduced induction dose of 5 mg twice daily and 47% were on concomitant anti-thrombotic therapy. Malignancies were registered in two patients from Group 1 and one patient from Group 2.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Modulation of induction dose and anti-thrombotic therapy may have contributed to prevent cardiological events and thromboembolism. The introduction of zoster vaccine virtually eliminated zoster risk after the first cases. Potential malignancies deserve a careful work-up of older patients before treatment start.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjad158","type":"journal-article","created":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T20:21:30Z","timestamp":1694463690000},"page":"488-491","source":"Crossref","is-referenced-by-count":16,"title":["Mitigating the Risk of Tofacitinib-induced Adverse Events in the Elderly Population with Ulcerative Colitis"],"prefix":"10.1093","volume":"18","author":[{"given":"Anna","family":"Viola","sequence":"first","affiliation":[{"name":"Deparrtment of Clinical and Experimental Medicine, University of Messina , Messina , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raffaele","family":"Li Voti","sequence":"additional","affiliation":[{"name":"Deparrtment of Clinical and Experimental Medicine, University of Messina , Messina , Italy"},{"name":"Department of Health Promotion, Mother & Child Care, Internal Medicine & Medical Specialties, PROMISE, Gastroenterology & Hepatology Unit, University of Palermo , Palermo , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Bivacqua","sequence":"additional","affiliation":[{"name":"Deparrtment of Clinical and Experimental Medicine, University of Messina , Messina , Italy"},{"name":"Department of Health Promotion, Mother & Child Care, Internal Medicine & Medical Specialties, PROMISE, Gastroenterology & Hepatology Unit, University of Palermo , Palermo , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clara","family":"De Francesco","sequence":"additional","affiliation":[{"name":"Deparrtment of Clinical and Experimental Medicine, University of Messina , Messina , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Muscianisi","sequence":"additional","affiliation":[{"name":"Deparrtment of Clinical and Experimental Medicine, University of Messina , Messina , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Costantino","sequence":"additional","affiliation":[{"name":"Deparrtment of Clinical and Experimental Medicine, University of Messina , Messina , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6159-7478","authenticated-orcid":false,"given":"Walter","family":"Fries","sequence":"additional","affiliation":[{"name":"Deparrtment of Clinical and Experimental Medicine, University of Messina , Messina , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,9,13]]},"reference":[{"key":"2024030118321232600_CIT0001","author":"EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders"},{"key":"2024030118321232600_CIT0002","doi-asserted-by":"crossref","first-page":"441","DOI":"10.1007\/s40266-022-00943-0","article-title":"Ulcerative colitis in adulthood and in older patients: Same disease, same outcome, same risks","volume":"39","author":"Fries","year":"2022","journal-title":"Drugs Aging"},{"key":"2024030118321232600_CIT0003","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1016\/0021-9681(87)90171-8","article-title":"A new method of classifying prognostic comorbidity in longitudinal studies: development and validation","volume":"40","author":"Charlson","year":"1987","journal-title":"J Chronic Dis"},{"key":"2024030118321232600_CIT0004","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1186\/1471-230X-12-79","article-title":"13-year mortality trends among hospitalized patients with inflammatory bowel disease","volume":"12","author":"Sewell","year":"2012","journal-title":"BMC Gastroenterol"},{"key":"2024030118321232600_CIT0005","doi-asserted-by":"crossref","first-page":"749","DOI":"10.1136\/gut.2005.082909","article-title":"The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications","volume":"55","author":"Satsangi","year":"2006","journal-title":"Gut"},{"key":"2024030118321232600_CIT0006","doi-asserted-by":"crossref","first-page":"M14656","DOI":"10.1093\/gerona\/56.3.M146","article-title":"Frailty in older adults: evidence for a phenotype. Cardiovascular Health Study Collaborative Research Group","volume":"56","author":"Fried","year":"2001","journal-title":"J Gerontol A Biol Sci Med Sci"},{"key":"2024030118321232600_CIT0007","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1093\/ibd\/izac084","article-title":"Assessment of safety and efficacy of tofacitinib, stratified by age, in patients from the ulcerative colitis clinical program","volume":"29","author":"Lichtenstein","year":"2023","journal-title":"Inflamm Bowel Dis"},{"key":"2024030118321232600_CIT0008","doi-asserted-by":"crossref","first-page":"1189389","DOI":"10.3389\/fphar.2023.1189389","article-title":"Risk of venous thromboembolism with janus kinase inhibitors in inflammatory immune diseases: a systematic review and meta-analysis","volume":"14","author":"Zhang","year":"2023","journal-title":"Front Pharmacol"},{"key":"2024030118321232600_CIT0009","doi-asserted-by":"crossref","first-page":"4857","DOI":"10.3748\/wjg.v20.i17.4857","article-title":"Venous thrombosis and prothrombotic factors in inflammatory bowel disease","volume":"20","author":"Magro","year":"2014","journal-title":"World J Gastroenterol"},{"key":"2024030118321232600_CIT0010","doi-asserted-by":"crossref","first-page":"2272","DOI":"10.1111\/j.1572-0241.2008.02052.x","article-title":"Rising prevalence of venous thromboembolism and its impact on mortality among hospitalized inflammatory bowel disease patients","volume":"103","author":"Nguyen","year":"2008","journal-title":"Am J Gastroenterol"},{"key":"2024030118321232600_CIT0011","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1093\/ecco-jcc\/jjx008","article-title":"Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 1: Definitions, diagnosis, extra-intestinal manifestations, pregnancy, cancer surveillance, surgery, and ileo-anal pouch disorders","volume":"11","author":"Magro","year":"2017","journal-title":"J Crohns Colitis"},{"key":"2024030118321232600_CIT0012","doi-asserted-by":"crossref","first-page":"835","DOI":"10.1053\/j.gastro.2014.01.042","article-title":"Consensus statements on the risk, prevention, and treatment of venous thromboembolism in inflammatory bowel disease: Canadian Association of Gastroenterology","volume":"146","author":"Nguyen","year":"2014","journal-title":"Gastroenterology"},{"key":"2024030118321232600_CIT0013","author":"Summary of product characteristics"}],"container-title":["Journal of Crohn's and Colitis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ecco-jcc\/advance-article-pdf\/doi\/10.1093\/ecco-jcc\/jjad158\/51854983\/jjad158.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ecco-jcc\/article-pdf\/18\/3\/488\/56813926\/jjad158.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ecco-jcc\/article-pdf\/18\/3\/488\/56813926\/jjad158.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T18:32:21Z","timestamp":1709317941000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ecco-jcc\/article\/18\/3\/488\/7272706"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,13]]},"references-count":13,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,9,13]]},"published-print":{"date-parts":[[2024,3,1]]}},"URL":"https:\/\/doi.org\/10.1093\/ecco-jcc\/jjad158","relation":{},"ISSN":["1873-9946","1876-4479"],"issn-type":[{"value":"1873-9946","type":"print"},{"value":"1876-4479","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,3,1]]},"published":{"date-parts":[[2023,9,13]]}}}