{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T16:45:16Z","timestamp":1790873116004,"version":"4.1.0"},"reference-count":27,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,2,12]],"date-time":"2019-02-12T00:00:00Z","timestamp":1549929600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis Care &amp; Research"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate ixekizumab safety in adults with psoriatic arthritis (PsA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Safety data from 2 integrated data sets are presented: 1) 24\u2010week, double\u2010blind, placebo\u2010controlled period of <jats:styled-content style=\"fixed-case\">SPIRIT<\/jats:styled-content>\u2010P1 and <jats:styled-content style=\"fixed-case\">SPIRIT<\/jats:styled-content>\u2010P2; and 2) all ixekizumab\u2010treated patients of <jats:styled-content style=\"fixed-case\">SPIRIT<\/jats:styled-content>\u2010P1 and <jats:styled-content style=\"fixed-case\">SPIRIT<\/jats:styled-content>\u2010P2 plus <jats:styled-content style=\"fixed-case\">SPIRIT<\/jats:styled-content>\u2010P3 open\u2010label period. We report adverse event (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>) frequency and exposure\u2010adjusted incidence rates per 100 patient\u2010years at 12\u2010week intervals to week 96.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The placebo\u2010controlled period had 678 patients (safety population): 224 placebo, 229 ixekizumab every 4\u00a0weeks, and 225 ixekizumab every 2\u00a0weeks. Overall, 1,118 patients received ixekizumab (total exposure 1,373.4 patient\u2010years). In the placebo\u2010controlled period, the frequencies of ixekizumab\u2010treated patients experiencing \u22651 treatment\u2010emergent <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content> (<jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>) and those experiencing serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were 68.1% (56.7% placebo) and 4.4% (2.7% placebo), respectively. Injection site reactions (<jats:styled-content style=\"fixed-case\">ISR<\/jats:styled-content>s) were very common (21.4% ixekizumab [4.5% placebo]), with <jats:styled-content style=\"fixed-case\">ISR<\/jats:styled-content> discontinuation rates of 1.1% (ixekizumab) and 0.4% (placebo). Through week 96, the incidence rates of <jats:styled-content style=\"fixed-case\">ISR<\/jats:styled-content>s decreased with increasing ixekizumab exposure. The frequencies of <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s of special interest were 32.8% (ixekizumab) and 27.7% (placebo); for serious infections, the frequencies were 1.3% and 0%, respectively; <jats:italic>Candida<\/jats:italic> infections, 2.6% and 0.4%; confirmed major adverse cardiac events, 0% and 0%; malignancy, 0.4% and 0%; hypersensitivities, 5.3% and 1.8%; and depression\u2010related, 1.8% and 1.3%. The frequency of Crohn's disease and ulcerative colitis (investigator\u2010reported) was 0% in both groups, and the frequencies of sponsor\u2010determined inflammatory bowel disease were 0.2% in the ixekizumab group and 0% in the placebo group. Overall, no active tuberculosis, invasive <jats:italic>Candida<\/jats:italic> infections, anaphylaxis, or suicide\/self\u2010injury behaviors were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The PsA ixekizumab safety integrated data set reached 1,373.4 patient\u2010years total exposure. Ixekizumab\u2010treated patients had higher rates of overall <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s, serious infections, mucocutaneous <jats:italic>Candida<\/jats:italic>, hypersensitivities (non\u2010anaphylactic), and <jats:styled-content style=\"fixed-case\">ISR<\/jats:styled-content>s than placebo\u2010treated patients. No unexpected safety outcomes were reported.<\/jats:p><\/jats:sec>","DOI":"10.1002\/acr.23738","type":"journal-article","created":{"date-parts":[[2018,8,30]],"date-time":"2018-08-30T04:48:04Z","timestamp":1535604484000},"page":"367-378","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":58,"title":["Safety of Ixekizumab in Patients With Psoriatic Arthritis: Results From a Pooled Analysis of Three Clinical Trials"],"prefix":"10.1002","volume":"71","author":[{"given":"Philip","family":"Mease","sequence":"first","affiliation":[{"name":"Swedish Medical Center and University of Washington  Seattle"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Euthalia","family":"Roussou","sequence":"additional","affiliation":[{"name":"King George Hospital  Goodmayes Essex 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