{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T19:24:20Z","timestamp":1788809060339,"version":"build-2803163510"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2022,11,7]],"date-time":"2022-11-07T00:00:00Z","timestamp":1667779200000},"content-version":"vor","delay-in-days":0,"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":[[2023,1,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>In patients with ulcerative colitis (UC), risks of infection and malignancies increase with age. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC. This analysis assessed age as a risk factor for adverse events of special interest (AESI) in the tofacitinib UC clinical program.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Data were from phase 2 and 3 induction studies, a phase 3 maintenance study, and an open-label, long-term extension study. Efficacy and\/or safety outcomes were analyzed in the Induction, Maintenance, and Overall Cohorts (patients who received\u2005\u2265\u20051 dose of tofacitinib), stratified by age. The effects of baseline demographic and disease-related factors on AESI incidence were assessed by Cox proportional-hazards regression analysis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the Overall Cohort (1157 patients with\u2005\u2264\u20056.8 years\u2019 tofacitinib treatment), age was a statistically significant predictor of herpes zoster (HZ), malignancies excluding nonmelanoma skin cancer (NMSC), and NMSC. Other statistically significant predictors included prior tumor necrosis factor inhibitor failure for HZ, NMSC, and opportunistic infection events, and prior duration of UC for malignancies excluding NMSC. In the Induction and Maintenance Cohorts, a higher proportion of tofacitinib-treated than placebo-treated patients (numerical difference) achieved the efficacy endpoints (endoscopic improvement, clinical remission, clinical response) across all age groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Older individuals receiving tofacitinib as induction and maintenance therapy to treat UC may have an increased risk of HZ, malignancies (excluding NMSC), and NMSC versus similarly treated younger patients, consistent with findings from the general population. Across all age groups, tofacitinib demonstrated greater efficacy than placebo as an induction and maintenance therapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>ClinicalTrials.gov Registration Numbers<\/jats:title>\n                  <jats:p>NCT00787202; NCT01465763; NCT01458951; NCT01458574; NCT01470612.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izac084","type":"journal-article","created":{"date-parts":[[2022,11,7]],"date-time":"2022-11-07T12:48:21Z","timestamp":1667825301000},"page":"27-41","source":"Crossref","is-referenced-by-count":40,"title":["Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program"],"prefix":"10.1093","volume":"29","author":[{"given":"Gary R","family":"Lichtenstein","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, Perelman School of Medicine at the University of Pennsylvania , Philadelphia, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Bressler","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, University of British Columbia , Vancouver, BC , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Francisconi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Federal University of Rio Grande do Sol, Gastroenterology Division, Hospital de Cl\u00ednicas de Porto Alegre , Porto Alegre , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9942-3019","authenticated-orcid":false,"given":"Severine","family":"Vermeire","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology & Hepatology, University Hospitals Leuven , Leuven , 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T","family":"Judd","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Jones","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, PA , 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"}]}],"member":"286","published-online":{"date-parts":[[2022,11,7]]},"reference":[{"key":"2023010801580180900_CIT0001","doi-asserted-by":"crossref","first-page":"384","DOI":"10.14309\/ajg.0000000000000152","article-title":"ACG clinical guideline: ulcerative colitis in adults","volume":"114","author":"Rubin","year":"2019","journal-title":"Am J 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