{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T19:23:22Z","timestamp":1788809002826,"version":"build-2803163510"},"reference-count":47,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T00:00:00Z","timestamp":1654041600000},"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>Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We report herpes zoster (HZ) incidence and risk factors in the tofacitinib UC clinical program (up to 7.8 years).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Proportions and incidence rates (IRs; unique patients with events\/100 patient-years) of HZ were evaluated in 4 cohorts: Induction (phase 2 and 3 induction study data), Maintenance (phase 3 maintenance study data), Overall (data from all phase 2, 3, and open-label, long-term extension studies), and Overall plus interim 6-month phase 3b and 4 data. Herpes zoster risk factors were assessed by Cox regression analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In the Induction and Maintenance Cohorts, IRs for HZ (nonserious and serious) were numerically higher with tofacitinib 10 mg twice daily (BID) vs placebo and tofacitinib 10 vs 5 mg BID, respectively. With all tofacitinib doses (5 or 10 mg BID), IRs (95% confidence intervals) for HZ in the Overall and Overall plus phase 3b\/4 Cohorts (total exposure, 2814.4 and 2999.7 patient-years, respectively) were 3.38 (2.73-4.15) and 3.30 (2.67-4.04), respectively. In the Overall plus phase 3b\/4 Cohort, &amp;gt;90% of HZ were nonserious; &amp;gt;90% were mild\/moderate; &amp;gt;90% resolved without discontinuing tofacitinib; 0.6% of patients had multiple HZ events. Herpes zoster IRs were stable when analyzed by 6-month intervals up to &amp;gt;30 months. Herpes zoster risk factors included older age, lower weight, geographic region, and prior tumor necrosis factor inhibitor (TNFi) failure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Most HZ events were mild\/moderate. Herpes zoster IRs remained stable over 7.8 years of exposure. Older age, lower weight, geographic region, and prior TNFi failure were associated with increased HZ risk.<\/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\/ibd\/izac063","type":"journal-article","created":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T11:05:32Z","timestamp":1654081532000},"page":"85-96","source":"Crossref","is-referenced-by-count":32,"title":["Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib"],"prefix":"10.1093","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3892-6947","authenticated-orcid":false,"given":"Kevin L","family":"Winthrop","sequence":"first","affiliation":[{"name":"Oregon Health & Science University , Portland, Oregon , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9verine","family":"Vermeire","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University Hospitals Leuven , Leuven , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5983-2758","authenticated-orcid":false,"given":"Millie D","family":"Long","sequence":"additional","affiliation":[{"name":"University of North Carolina, Center for Gastrointestinal Biology and Disease , Chapel Hill, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julian","family":"Pan\u00e9s","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hospital Cl\u00ednic de Barcelona, IDIBAPS, CIBERehd , Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siew C","family":"Ng","sequence":"additional","affiliation":[{"name":"Institute of Digestive Disease, Department of Medicine and Therapeutics, LKS Institute of Health Science, Chinese University of Hong Kong , Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Kulisek","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajiv","family":"Mundayat","sequence":"additional","affiliation":[{"name":"Pfizer Inc ** , New York, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nervin","family":"Lawendy","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivana","family":"Vranic","sequence":"additional","affiliation":[{"name":"Pfizer Ltd , Tadworth, Surrey , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Modesto","sequence":"additional","affiliation":[{"name":"Pfizer Inc ** , New York, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chinyu","family":"Su","sequence":"additional","affiliation":[{"name":"Pfizer Inc , Collegeville, Pennsylvania , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gil Y","family":"Melmed","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Cedars-Sinai Medical Center , Los Angeles, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,6,1]]},"reference":[{"key":"2023010801581087200_CIT0001","doi-asserted-by":"crossref","first-page":"1606","DOI":"10.1016\/S0140-6736(12)60150-0","article-title":"Ulcerative colitis","volume":"380","author":"Ord\u00e1s","year":"2012","journal-title":"Lancet."},{"key":"2023010801581087200_CIT0002","doi-asserted-by":"crossref","first-page":"2328","DOI":"10.1002\/art.39670","article-title":"Risk of herpes zoster in auto-immune and 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