{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T13:46:43Z","timestamp":1787838403687,"version":"build-2784847793"},"reference-count":29,"publisher":"The Journal of Rheumatology","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objective.<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of ixekizumab (IXE), an interleukin 17A antagonist, in patients with psoriatic arthritis (PsA) after 52 weeks in a phase III study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods.<\/jats:title>\n                    <jats:p>Patients were initially randomly assigned to IXE 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after a 160-mg starting dose, placebo (PBO), or adalimumab (ADA) 40 mg Q2W. At Week 24 (Week 16 for inadequate responders), ADA (8-week washout before starting IXE) and PBO patients were rerandomized to IXEQ2W or IXEQ4W. Six treatment groups were evaluated in the extension period (weeks 24\u201352): IXEQ2W\/IXEQ2W, IXEQ4W\/IXEQ4W, ADA\/IXEQ2W, ADA\/IXEQ4W, PBO\/IXEQ2W, and PBO\/IXEQ4W. The extension period population (EPP) included patients who received \u2265 1 dose of study medication during the extension period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results.<\/jats:title>\n                    <jats:p>There were 381\/417 (91.4%) patients who entered the extension period. In the IXEQ4W\/IXEQ4W and IXEQ2W\/IXEQ2W groups (EPP), respectively, American College of Rheumatology (ACR)20 (69.1% and 68.8%), ACR50 (54.6% and 53.1%), and ACR70 (39.2% and 39.6%) response rates were sustained at Week 52. Patients rerandomized to IXE also demonstrated efficacy measured by ACR response rates at Week 52. A similar pattern was observed for Psoriasis Area and Severity Index outcomes. Radiographic progression in all 6 groups was minimal. The most frequently reported treatment-emergent adverse events (\u2265 4%) were nasopharyngitis, injection site reaction, injection site erythema, upper respiratory tract infection, and back pain. No deaths were reported, and serious adverse event frequency was 0\u20134% with IXE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion.<\/jats:title>\n                    <jats:p>\n                      During the extension period, IXEQ4W or IXEQ2W treatment demonstrated sustained efficacy in key PsA domains with a safety profile consistent with other studies investigating IXE. Clinical trial number:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01695239\">NCT01695239<\/jats:ext-link>\n                      ; EudraCT 2011-002326-49.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3899\/jrheum.170429","type":"journal-article","created":{"date-parts":[[2017,12,15]],"date-time":"2017-12-15T20:20:44Z","timestamp":1513369244000},"page":"367-377","source":"Crossref","is-referenced-by-count":105,"title":["Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1)"],"prefix":"10.3899","volume":"45","author":[{"given":"D\u00e9sir\u00e9e","family":"van der Heijde","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dafna D.","family":"Gladman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsumasa","family":"Kishimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masato","family":"Okada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suchitrita S.","family":"Rathmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan R.","family":"Moriarty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine L.","family":"Shuler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilde","family":"Carlier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Benichou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip J.","family":"Mease","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2262","published-online":{"date-parts":[[2017,12,15]]},"reference":[{"key":"2018112909375713000_45.3.367.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rdc.2015.07.003"},{"key":"2018112909375713000_45.3.367.2","doi-asserted-by":"publisher","DOI":"10.1002\/art.23655"},{"key":"2018112909375713000_45.3.367.3","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2009.399"},{"key":"2018112909375713000_45.3.367.4","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.1100123"},{"key":"2018112909375713000_45.3.367.5","doi-asserted-by":"publisher","DOI":"10.1002\/art.33396"},{"key":"2018112909375713000_45.3.367.6","doi-asserted-by":"crossref","first-page":"1272","DOI":"10.1002\/art.38376","article-title":"Interleukin-17+CD8+ T cells are enriched in the joints of patients with psoriatic arthritis and correlate with disease activity and joint damage progression","volume":"66","author":"Menon","year":"2014","journal-title":"Arthritis Rheumatol"},{"key":"2018112909375713000_45.3.367.7","doi-asserted-by":"crossref","first-page":"2673","DOI":"10.1002\/art.39261","article-title":"Brief report: enrichment of activated group 3 innate lymphoid cells in psoriatic arthritis synovial fluid","volume":"67","author":"Leijten","year":"2015","journal-title":"Arthritis Rheumatol"},{"key":"2018112909375713000_45.3.367.8","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208337"},{"key":"2018112909375713000_45.3.367.9","doi-asserted-by":"crossref","first-page":"39","DOI":"10.2147\/JIR.S100940","article-title":"Generation and characterization of ixekizumab, a humanized monoclonal antibody that neutralizes interleukin-17A","volume":"9","author":"Liu","year":"2016","journal-title":"J Inflamm Res"},{"key":"2018112909375713000_45.3.367.10","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209709"},{"key":"2018112909375713000_45.3.367.11","unstructured":"Ixekizumab [prescribing information]. 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