{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T11:04:10Z","timestamp":1788951850011,"version":"build-2803163510"},"reference-count":41,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,11,26]],"date-time":"2024-11-26T00:00:00Z","timestamp":1732579200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Psoriasis (PsO), a chronic inflammatory skin disorder affecting a substantial proportion of populations globally, often necessitates systemic treatment including biologics. This 14\u2010year cohort study, based on Danish national register data, aimed to investigate the enduring safety profile of ustekinumab compared to other systemic psoriasis treatments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Using comprehensive Danish national register data, this study scrutinized patients diagnosed with psoriasis or psoriatic arthritis (PsA) who received ustekinumab. The treatment group comparators were non\u2010biological systemic treatment (non\u2010biologic), tumor necrosis factor \u03b1 inhibitor medicine groups (TNF\u2010\u03b1), interleukin (IL)\u201017 inhibitors (IL\u201017), and IL\u201023 inhibitors (IL\u201023). The study periods for comparisons were 2009\u20132022 for non\u2010biologic and TNF\u2010\u03b1, 2015\u20132022 for IL\u201017, and 2018\u20132022 for IL\u201023. Outcomes were malignancies, cardiovascular events, serious infections, and serious hypersensitivity reactions. Cox proportional hazards regression models were employed to analyze two estimands: a standard intention\u2010to\u2010treat (ITT) estimand and a continuous\u2010index\u2010treatment (CIT) estimand, which considered switch and re\u2010initiation of treatments within individuals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Users of ustekinumab were found to be younger on average, with an average age of 45.1\u2009years compared to 51.6, 47.2, 49.0, and 48.4\u2009years in the non\u2010biologic, TNF\u2010\u03b1, IL\u201017, and IL\u201023 groups, respectively. Also, 57.3% of the ustekinumab users were male, compared to 46.7%, 48.9%, 50.9%, and 58.3% for the non\u2010biologic, TNF\u2010\u03b1, IL\u201017, and IL\u201023 groups, respectively. Although the hazard ratio estimates varied across comparators, ustekinumab was found to be safe: regardless of PsA status, no discernible safety signals in terms of malignancy, MACE, severe infections, or severe hypersensitivity reactions were observed for ustekinumab when compared to the treatment comparators.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The present study corroborated the enduring safety of ustekinumab in the context of PsO treatment.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.70064","type":"journal-article","created":{"date-parts":[[2024,11,27]],"date-time":"2024-11-27T06:13:52Z","timestamp":1732688032000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Post\u2010Marketing Safety of Ustekinumab Based on 14\u2010Year Follow\u2010Up in Danish National Patient 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