{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T18:09:50Z","timestamp":1791828590951,"version":"4.3.4"},"reference-count":36,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,3,8]],"date-time":"2019-03-08T00:00:00Z","timestamp":1552003200000},"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 & Rheumatology"],"published-print":{"date-parts":[[2019,4]]},"abstract":"\n Objective<\/jats:title>\n \n To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (SpA) and prior inadequate response to or intolerance of 1 or 2 tumor necrosis factor inhibitors (\n TNF<\/jats:styled-content>\n i).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n In this phase\n III<\/jats:styled-content>\n randomized, double\u2010blind, placebo\u2010controlled trial, adult patients with an inadequate response to or intolerance of 1 or 2\n TNF<\/jats:styled-content>\n i and an established diagnosis of axial SpA (according to the Assessment of SpondyloArthritis international Society [\n ASAS<\/jats:styled-content>\n ] criteria for radiographic axial SpA, with radiographic sacroiliitis defined according to the modified New York criteria and \u22651 feature of SpA) were recruited and randomized 1:1:1 to receive placebo or 80\u2010mg subcutaneous ixekizumab every 2 weeks (\n IXE<\/jats:styled-content>\n Q2W) or 4 weeks (\n IXEQ4W<\/jats:styled-content>\n ), with an 80\u2010mg or 160\u2010mg starting dose. The primary end point was 40% improvement in disease activity according to the\n ASAS<\/jats:styled-content>\n criteria (\n ASAS<\/jats:styled-content>\n 40) at week 16. Secondary outcomes and safety were also assessed.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 316 patients were randomized to receive placebo (n = 104),\n IXEQ2W<\/jats:styled-content>\n (n = 98), or\n IXEQ4W<\/jats:styled-content>\n (n = 114). At week 16, significantly higher proportions of\n IXEQ2W<\/jats:styled-content>\n patients (n = 30 [30.6%];\n P<\/jats:italic>\n = 0.003) or\n IXEQ4W<\/jats:styled-content>\n patients (n = 29 [25.4%];\n P<\/jats:italic>\n = 0.017) had achieved an\n ASAS<\/jats:styled-content>\n 40 response versus the placebo group (n = 13 [12.5%]), with statistically significant differences reported as early as week 1 with ixekizumab treatment. Statistically significant improvements in disease activity, function, quality of life, and spinal magnetic resonance imaging\u2013evident inflammation were observed after 16 weeks of ixekizumab treatment versus placebo. Treatment\u2010emergent adverse events (\n AE<\/jats:styled-content>\n s) with ixekizumab treatment were more frequent than with placebo. Serious\n AE<\/jats:styled-content>\n s were similar across treatment arms. One death was reported (\n IXEQ2W<\/jats:styled-content>\n group).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n Ixekizumab treatment for 16 weeks in patients with active radiographic axial SpA and previous inadequate response to or intolerance of 1 or 2\n TNF<\/jats:styled-content>\n i yields rapid and significant improvements in the signs and symptoms of radiographic axial SpA versus placebo.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/art.40753","type":"journal-article","created":{"date-parts":[[2018,10,20]],"date-time":"2018-10-20T21:30:59Z","timestamp":1540071059000},"page":"599-611","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":206,"title":["Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen\u2010Week Results\u00a0From a Phase\n III<\/scp>\n Randomized, Double\u2010Blind, Placebo\u2010Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors"],"prefix":"10.1002","volume":"71","author":[{"given":"Atul","family":"Deodhar","sequence":"first","affiliation":[{"name":"Oregon Health & Science University Portland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4537-6015","authenticated-orcid":false,"given":"Denis","family":"Poddubnyy","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsmedizin Berlin and German Rheumatism Research Centre Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cesar","family":"Pacheco\u2010Tena","sequence":"additional","affiliation":[{"name":"Universidad Aut\u00f3noma de Chihuahua Chihuahua Deodhar Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Salvarani","sequence":"additional","affiliation":[{"name":"Azienda USL\u2010IRCCS di Reggio Emilia and Universita\u2019 di Modena e Reggio Emilia Reggio Emilia 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