{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T14:22:34Z","timestamp":1788790954389,"version":"build-2803163510"},"reference-count":17,"publisher":"The Journal of Rheumatology","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2023,8]]},"abstract":"\n Objective<\/jats:title>\n To report safety and efficacy of ixekizumab (IXE) from the COAST program at 3 years, including 1 year from the originating studies (COAST-V, COAST-W, and COAST-X), and 2 years from COAST-Y.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n In COAST-Y, patients continued with the dose received at the end of the originating study at week 52: 80 mg IXE either every 4 weeks (Q4W) or every 2 weeks (Q2W). Placebo-treated patients from COAST-X received IXE Q4W in COAST-Y. Starting at week 116 (week 64 of COAST-Y), patients receiving IXE Q4W could be escalated to Q2W. Safety for patients receiving \u2265 1 dose of IXE and efficacy for patients receiving \u2265 1 dose of IXE Q4W was assessed. Data are summarized as observed.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n For the 932 patients who received \u2265 1 dose of IXE (Q2W or Q4W) through 3 years, treatment-emergent adverse events (TEAEs) occurred at an incidence rate (IR) of 38.0 per 100 patient-years (PYs). The most frequently reported were infections (IR 25.7 per 100 PYs) and injection site reactions (IR 7.4 per 100 PYs); the majority of TEAEs were mild or moderate in severity. In total, 7.1% of TEAEs led to discontinuation (IR 3.1 per 100 PYs). All patient groups receiving IXE Q4W assessed through 3 years saw sustained improvements in Ankylosing Spondylitis Disease Activity Score, clinically important improvement, and other efficacy end points.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n The 3-year safety profile of IXE in the COAST program is consistent with the previously established long-term safety profile. IXE Q4W provided sustained improvement of disease activity in patients who received treatment through 3 years. (\n ClinicalTrials.gov<\/jats:ext-link>\n :\n NCT02696785<\/jats:ext-link>\n [COAST-V],\n NCT02696798<\/jats:ext-link>\n [COAST-W],\n NCT02757352<\/jats:ext-link>\n [COAST-X], and\n NCT03129100<\/jats:ext-link>\n [COAST-Y])\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3899\/jrheum.221022","type":"journal-article","created":{"date-parts":[[2023,3,16]],"date-time":"2023-03-16T14:02:53Z","timestamp":1678975373000},"page":"1020-1028","source":"Crossref","is-referenced-by-count":17,"title":["Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST 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