{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T01:18:48Z","timestamp":1792718328452,"version":"4.5.0"},"reference-count":30,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,8,5]],"date-time":"2025-08-05T00:00:00Z","timestamp":1754352000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis & Rheumatology"],"published-print":{"date-parts":[[2025,11]]},"abstract":"\n Objective<\/jats:title>\n This randomized, double\u2010blind, adaptive phase 2\/3 trial aimed to evaluate the efficacy and safety of ivarmacitinib, a novel selective JAK1 inhibitor, in patients with active ankylosing spondylitis (AS).<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n In phase 2, patients were randomized (1:1:1:1) to receive ivarmacitinib at a dose of 2, 4, or 8 mg or placebo once daily for 12 weeks. Based on interim analysis, ivarmacitinib 4 mg was selected as the recommended dose. In phase 3, patients were randomized (1:1) to receive ivarmacitinib 4 mg or placebo for 12 weeks; from week 12 onward, all patients received ivarmacitinib 4 mg once daily through week 24. The primary end point was the proportion of patients achieving a \u226520% improvement in the Assessment of SpondyloArthritis international Society (ASAS20) response criteria at week 12.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n During the entire study, 504 patients were randomized (ivarmacitinib 4 mg, n = 187; placebo, n = 186). At week 12, the ASAS20 response rate was significantly higher in the ivarmacitinib 4 mg group compared to the placebo group (48.7% vs 29.0%; one\u2010sided\n P<\/jats:italic>\n = 0.0001). The ASAS40 response rate (32.1% vs 18.3%) and all other secondary end points also favored ivarmacitinib 4 mg. Efficacy was sustained through 24 weeks. During the placebo\u2010controlled period, treatment\u2010emergent adverse events occurred in 79.7% of the ivarmacitinib group and 65.6% of the placebo group.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Ivarmacitinib 4 mg significantly improved the signs and symptoms of AS at week 12 compared to placebo, with sustained efficacy through 24 weeks and a tolerable safety profile. These findings support ivarmacitinib 4 mg as a new treatment option for active AS.<\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/art.43238","type":"journal-article","created":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T02:39:46Z","timestamp":1749782386000},"page":"1512-1523","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Efficacy and Safety of Ivarmacitinib, a Selective\n JAK1<\/scp>\n Inhibitor, in Patients With Active Ankylosing Spondylitis: Results From an Adaptive Seamless Phase 2\/3 Trial"],"prefix":"10.1002","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4107-894X","authenticated-orcid":false,"given":"Xu","family":"Liu","sequence":"first","affiliation":[{"name":"Department of Rheumatology and Immunology Peking University People's Hospital Beijing 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