{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T00:46:16Z","timestamp":1793666776603,"version":"4.5.1"},"reference-count":47,"publisher":"American Medical Association (AMA)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Dermatol"],"published-print":{"date-parts":[[2025,1,1]]},"abstract":"\n Importance<\/jats:title>\n Safe and effective long-term treatments for moderate to severe plaque psoriasis are needed.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the long-term safety and efficacy of deucravacitinib through 3 years (week 148) in the randomized POETYK PSO-1, PSO-2, and nonrandomized long-term extension (LTE) trials.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n PSO-1\/PSO-2 were global, 52-week, randomized, double-blinded phase 3 trials in patients with moderate to severe plaque psoriasis. After completing 52 weeks of treatment in PSO-1\/PSO-2, patients could enroll in the prespecified, ongoing, nonrandomized LTE trial. The peak of the global COVID-19 pandemic coincided with the LTE trial. Patient enrollment in the LTE started August 12, 2019; safety and efficacy were assessed through June 15, 2022; and these data were analyzed through June 28, 2024.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n The PSO-1\/PSO-2 trials randomized patients 1:2:1 to oral placebo, deucravacitinib, 6 mg once daily, or apremilast, 30 mg twice daily. Patients enrolling in the LTE trial received open-label deucravacitinib, 6 mg once daily.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes And Measures<\/jats:title>\n Safety outcomes were evaluated in patients who received 1 or more doses of deucravacitinib. Efficacy outcomes included 75% or greater or 90% or greater reduction from baseline in Psoriasis Area and Severity Index (PASI 75\/90) and static Physician Global Assessment scores of 0 (clear) or 1 (almost clear) (sPGA 0\/1) and were assessed in patients who received deucravacitinib treatment from day 1 of the parent trials who continued in the LTE trial.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Of 1519 patients who received 1 or more doses of deucravacitinib, 513 received continuous deucravacitinib treatment from day 1 and entered the LTE trial. Exposure-adjusted incidence rates (EAIRs) per 100 person-years were decreased or similar in the 1-year vs 3-year cumulative periods, respectively, for adverse events (AEs) (229.2 vs 144.8; 95% CI, 215.4-243.9 vs 137.1-153.0), serious AEs (5.7 vs 5.5; 95% CI, 4.4-7.4 vs 4.7-6.4), discontinuations due to AEs (4.4 vs 2.4; 95% CI, 3.3-5.9 vs 2.0-3.0), and deaths (0.2 vs 0.3; 95% CI, 0.1-0.8 vs 0.2-0.6). Incidence rates of the most common AEs (EAIR per 100 person-years \u22655) during the 1-year and 3-year cumulative periods, respectively, were nasopharyngitis (26.1 vs 11.4; 95% CI, 23.0-29.8 vs 10.2-12.7), COVID-19 (0.5 vs 8.0; 95% CI, 0.2-1.2 vs 7.1-9.1), and upper respiratory tract infection (13.4 vs 6.2; 95% CI, 11.3-16.0 vs 5.4-7.2). EAIRs for AEs of interest, including herpes zoster, major adverse cardiovascular events, and malignant diseases, remained low and were decreased or comparable between the 1-year and 3-year cumulative periods. Clinical response rates were maintained through 3 years.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n The findings of this integrated analysis of the phase 3 POETYK PSO-1, PSO-2, and nonrandomized LTE trials demonstrate a consistent safety profile and durable clinical response of continuous treatment with deucravacitinib through 3 years of treatment in patients with psoriasis.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifiers:\n NCT03624127<\/jats:ext-link>\n ,\n NCT03611751<\/jats:ext-link>\n , and\n NCT04036435<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamadermatol.2024.4688","type":"journal-article","created":{"date-parts":[[2024,11,27]],"date-time":"2024-11-27T11:34:13Z","timestamp":1732707253000},"page":"56","source":"Crossref","is-referenced-by-count":61,"title":["Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years"],"prefix":"10.1001","volume":"161","author":[{"given":"April W.","family":"Armstrong","sequence":"first","affiliation":[{"name":"Division of Dermatology, University of California Los Angeles David Geffen School of Medicine, Los Angeles"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Lebwohl","sequence":"additional","affiliation":[{"name":"Kimberly and Eric J. 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