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Baseline 10-year atherosclerotic cardiovascular disease (ASCVD) risk was determined in patients without history of ASCVD (48-week cohorts). Adverse events (AEs)\/AEs of special interest were evaluated\/compared with findings from other tofacitinib programs (16 Phase 2\/Phase 3 rheumatoid arthritis [RA]; 2 Phase 3 psoriatic arthritis [PsA] RCTs) and a real-world cohort of AS patients initiating biologic disease-modifying antirheumatic drugs (US MarketScan).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Most patients (&gt;\u200975%; 48-week cohorts) without history of ASCVD had low baseline 10-year ASCVD risk. One patient (tofacitinib 5\u00a0mg BID; in all 3 cohorts) had a serious infection (aseptic meningitis). Herpes zoster (non-serious) occurred in the 48-week only-tofacitinib 5\u00a0mg BID (<jats:italic>n<\/jats:italic>\u2009=\u20095 [1.6%]) and all-tofacitinib (<jats:italic>n<\/jats:italic>\u2009=\u20097 [1.7%]; one multi-dermatomal [tofacitinib 10\u00a0mg BID]) cohorts. No deaths, opportunistic infections, tuberculosis, malignancies, major adverse cardiovascular events, thromboembolic events, gastrointestinal perforations occurred. Limitations: short RCT durations\/low patient numbers within cohorts.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Tofacitinib 5\u00a0mg BID was well tolerated to 48 weeks in AS patients; safety profile was consistent with RA\/PsA clinical programs and a cohort of AS patients from US routine clinical practice.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Clinical trial registration numbers<\/jats:title>\n                <jats:p>NCT01786668 (2013-02-06); NCT03502616 (2018-04-11).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s42358-024-00402-x","type":"journal-article","created":{"date-parts":[[2024,12,18]],"date-time":"2024-12-18T10:54:16Z","timestamp":1734519256000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis"],"prefix":"10.1186","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2130-1246","authenticated-orcid":false,"given":"Atul","family":"Deodhar","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Servet","family":"Akar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey R.","family":"Curtis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bassel","family":"El-Zorkany","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Magrey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cunshan","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Solomon B.","family":"Makgoeng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivana","family":"Vranic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sujatha","family":"Menon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dona L.","family":"Fleishaker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annette M.","family":"Diehl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lara","family":"Fallon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arne","family":"Yndestad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert B. 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Patients provided written informed consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"AD has received grant\/research support from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, GSK, Janssen, Novartis, Pfizer Inc, and UCB, and has been a consultant for AbbVie, Amgen, Aurinia, Bristol Myers Squibb, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer Inc, and UCB. SA has received grant\/research support from Pfizer Inc and has been a consultant for, and participated in speaker bureaus for, AbbVie, Amgen, Eli Lilly, MSD, Novartis, Pfizer Inc, and UCB. JRC has received grant\/research support from, and has been a consultant for, AbbVie, Amgen, Bristol Myers Squibb, CorEvitas, LLC (formerly Corrona, LLC), Eli Lilly, Janssen, Myriad, Novartis, Pfizer Inc, Sanofi, and UCB. BE-Z has received grant\/research support from, and has been a consultant for, AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Eva, Hekma, Janssen, MSD, New Bridge, Novartis, Pfizer Inc, Roche, Sandoz, Sanofi-Aventis, and Servier. MM has received grant\/research support from AbbVie, Bristol Myers Squibb, and UCB, and has been a consultant for AbbVie, Eli Lilly, Novartis, Pfizer Inc, and UCB. CW, JW, SBM, IV, SM, DLF, AMD, LF, and AY are employees and stockholders of Pfizer Inc. RBML has been a consultant for AbbVie, Bristol Myers Squibb, Eli Lilly, Galapagos NV, Gilead Sciences, Janssen, Novartis, Pfizer Inc, and UCB.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"87"}}