{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:28:32Z","timestamp":1792787312353,"version":"4.5.0"},"reference-count":44,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2021,5,26]],"date-time":"2021-05-26T00:00:00Z","timestamp":1621987200000},"content-version":"unspecified","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Pfizer Inc"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2021,5,4]]},"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseases.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The analysis included data from patients exposed to \u22651\u2009dose of tofacitinib in phase 1, 2, 3 or 3b\/4 clinical trials and long-term extension (LTE) studies (38 trials) in RA (23 trials), PsA (3 trials), UC (5 trials) and PsO (7 trials). All studies were completed by or before July 2019, except for one ongoing UC LTE study (data cut-off May 2019). IRs were obtained for AEs of special interest.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>13\u2009567 patients were included in the analysis (RA: n=7964; PsA: n=783; UC: n=1157; PsO: n=3663), representing 37\u2009066 patient-years of exposure. Maximum duration of exposure was 10.5 years (RA). AEs within the \u2018infections and infestations\u2019 System Organ Class were the most common in all diseases. Among AEs of special interest, IRs were highest for herpes zoster (non-serious and serious; 3.6, 1.8, 3.5 and 2.4 for RA, PsA, UC and PsO, respectively) and serious infections (2.5, 1.2, 1.7 and 1.3 for RA, PsA, UC and PsO, respectively). Age-adjusted and sex-adjusted mortality ratios (weighted for country) were \u22640.2 across cohorts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The tofacitinib safety profile in this analysis was generally consistent across diseases and with longer term follow-up compared with previous analyses.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rmdopen-2021-001595","type":"journal-article","created":{"date-parts":[[2021,5,27]],"date-time":"2021-05-27T12:39:33Z","timestamp":1622119173000},"page":"e001595","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":53,"title":["Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37\u2009066 patient-years of tofacitinib exposure"],"prefix":"10.1136","volume":"7","clinical-trial-number":[{"clinical-trial-number":"nct02092467","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Gerd R","family":"Burmester","sequence":"first","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Charit\u00e9 - Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2571-788X","authenticated-orcid":false,"given":"Peter","family":"Nash","sequence":"additional","affiliation":[{"name":"Department of Medicine, Griffith University, Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Dr. Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Papp","sequence":"additional","affiliation":[{"name":"Clinical Research, Probity Medical Research Inc, Waterloo, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lori","family":"Stockert","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas V","family":"Jones","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Collegeville, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huaming","family":"Tan","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Groton, Connecticut, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Madsen","sequence":"additional","affiliation":[{"name":"Pfizer Inc, New York City, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hernan","family":"Valdez","sequence":"additional","affiliation":[{"name":"Pfizer Inc, New York City, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanley B","family":"Cohen","sequence":"additional","affiliation":[{"name":"Metroplex Clinical Research Center, Dallas, Texas, USA"},{"name":"Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,5,27]]},"reference":[{"key":"2025090312340342000_7.2.e001595.1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciu104"},{"key":"2025090312340342000_7.2.e001595.2","unstructured":"Pfizer Inc . 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