{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T18:10:32Z","timestamp":1759428632900,"version":"build-2065373602"},"reference-count":32,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2020,9,10]],"date-time":"2020-09-10T00:00:00Z","timestamp":1599696000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Pfizer Inc"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["ACR Open Rheumatology"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Metabolic syndrome (MetS) is a cluster of concurrent risk factors for cardiovascular disease and type 2 diabetes. This post hoc analysis explored key efficacy and safety endpoints in patients with psoriatic arthritis (PsA) and MetS treated with tofacitinib.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Tofacitinib 5 and 10 mg twice daily and placebo data were pooled from two Phase\u00a03 studies (OPAL Broaden [12 months; ClinicalTrials.gov identifier NCT01877668]; OPAL Beyond [6 months; ClinicalTrials.gov identifier NCT01882439]); patients received one background conventional synthetic disease\u2010modifying antirheumatic drug. Patients were stratified by baseline presence\/absence of MetS. Efficacy and safety were reported to month\u00a03 (tofacitinib and placebo) and 6 (tofacitinib only). Efficacy outcomes included: American College of Rheumatology (ACR)20\/50\/70, Health Assessment Questionnaire\u2010Disability Index (HAQ\u2010DI) response, Psoriasis Area Severity Index (PASI)75 response, and enthesitis\/dactylitis resolution rates; and changes from baseline (\u0394) in C\u2010reactive protein, HAQ\u2010DI, Patient\u2019s\/Physician\u2019s Global Assessment of Arthritis, and patient\u2010reported outcomes. Safety outcomes included treatment\u2010emergent all\u2010causality adverse events (AEs), \u0394 in lipid\/hepatic values, and liver parameter increases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 710 patients, 41.4% (n = 294) had baseline MetS. All efficacy outcomes improved with both tofacitinib doses versus placebo, to month 3; tofacitinib efficacy was consistent to month\u00a06, regardless of MetS status. MetS did not appear to affect the incidence of AEs or \u0394 in lipid\/hepatic values with tofacitinib up to month 3 or 6. Arterial thromboembolism and myocardial infarction (adjudicated major adverse cardiovascular events) were each reported once in tofacitinib\u2010treated patients with MetS.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Regardless of baseline MetS status, tofacitinib showed greater efficacy versus placebo in patients with active PsA. The tofacitinib safety profile appeared similar in patients with versus without MetS.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr2.11166","type":"journal-article","created":{"date-parts":[[2020,9,11]],"date-time":"2020-09-11T04:05:59Z","timestamp":1599797159000},"page":"543-554","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies"],"prefix":"10.1002","volume":"2","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2602-1219","authenticated-orcid":false,"given":"Christopher T.","family":"Ritchlin","sequence":"first","affiliation":[{"name":"University of Rochester Medical Center Rochester New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jon T.","family":"Giles","sequence":"additional","affiliation":[{"name":"Columbia University New York New 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