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Here, we assess 2-year efficacy, safety, and imaging outcomes in SELECT-AXIS 2.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients who received continuous upadacitinib, and those who switched from placebo to upadacitinib at week 14, could enter the open-label extension (OLE). Efficacy endpoints included Assessment of SpondyloArthritis international Society (ASAS) and Axial Spondyloarthritis Disease Activity Score (ASDAS) responses, and changes from baseline in measures of disease activity, back pain, function, and quality of life. Radiographic progression was evaluated using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). As observed (AO) and AO with non-responder imputation (AO-NRI) analyses were used for binary endpoints; AO with mixed-effects model for repeated measures (AO-MMRM) for continuous endpoints; and AO-analysis of covariance for mSASSS. Treatment-emergent adverse events (TEAEs) in patients receiving\u2009\u2265\u20091 upadacitinib dose through week 104 are presented as events (E)\/100 patient-years (PY). Subgroup analyses were performed by prior tumor necrosis factor\/interleukin-17 inhibitor exposure and bDMARD lack of efficacy\/intolerance.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of 420 patients who entered the bDMARD-IR AS study, 409 entered the OLE, and 331 (continuous upadacitinib, <jats:italic>n<\/jats:italic>\u2009=\u2009163; placebo to upadacitinib, <jats:italic>n<\/jats:italic>\u2009=\u2009168) completed week 104. Improvements in efficacy measures were sustained through the OLE, with similar response rates between the continuous upadacitinib and placebo to upadacitinib groups at week 104. At week 104, 64.9% and 61.7% of patients, respectively, had achieved ASAS 40% response (AO-NRI). Mean changes from baseline were similar between the two groups at week 104 across measures (ASDAS: -2.1 and -2.0; total back pain: -4.9 and -4.6, respectively; AO-MMRM). Over 93.0% of patients showed no radiographic progression (mSASSS mean change from baseline\u2009&lt;\u20092) at week 104. The overall TEAE rate was 165.2 E\/100 PY, with low rates of major adverse cardiovascular and venous thromboembolic events (0.3 E\/100 PY each).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Upadacitinib efficacy, including very low rates of radiographic progression, was demonstrated through 104 weeks in treatment-refractory patients with active AS. Treatment was well tolerated, with no newly identified safety signals.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>NCT04169373.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13075-024-03412-8","type":"journal-article","created":{"date-parts":[[2024,11,12]],"date-time":"2024-11-12T04:52:32Z","timestamp":1731387152000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis refractory to biologic therapy: 2-year clinical and radiographic results from the open-label extension of the SELECT-AXIS 2 study"],"prefix":"10.1186","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9475-9362","authenticated-orcid":false,"given":"Xenofon","family":"Baraliakos","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D\u00e9sir\u00e9e","family":"van der Heijde","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"Sieper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert Davies","family":"Inman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideto","family":"Kameda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter Peter","family":"Maksymowych","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan","family":"Lagunes-Galindo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xianwei","family":"Bu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Wung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Kato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Shmagel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atul","family":"Deodhar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,11,12]]},"reference":[{"issue":"12","key":"3412_CR1","doi-asserted-by":"publisher","first-page":"1511","DOI":"10.1136\/annrheumdis-2021-221035","volume":"80","author":"V Navarro-Comp\u00e1n","year":"2021","unstructured":"Navarro-Comp\u00e1n V, Sepriano A, El-Zorkany B, van der Heijde D. 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The trial protocol was approved by independent ethics committees and institutional review boards. Written informed consent was provided by patients ahead of study screening.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"XeB has received grant\/research support from AbbVie and Novartis; consulting fees from AbbVie, BMS, Chugai, MSD, Novartis, Pfizer, and UCB Pharma; speakers\u2019 bureau fees from AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB Pharma; is an editorial board member of the Annals of Rheumatic Diseases; is the ASAS President; and is the EULAR President-elect. DvdH has received consulting fees from AbbVie, ArgenX, BMS, Galapagos, GSK, Janssen, Lilly, Novartis, Pfizer, Takeda, and UCB Pharma; is an editorial board member of the Journal of Rheumatology, an editorial board member of RMD Open, an associate editor for the Annals of Rheumatic Diseases, an advisor for the Assessment of Axial Spondyloarthritis international Society, and the director of Imaging Rheumatology BV. JS has received grant\/research support from AbbVie, Merck, and UCB; has been a consultant for AbbVie, Merck, Novartis, and UCB; and has served on the speakers\u2019 bureau for AbbVie, Merck, and Novartis. RDI has received grant\/research support from AbbVie, Amgen, Janssen, and Novartis; and has been a consultant for AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer, and Sandoz. HK has received grant\/research support from AbbVie, Asahi-Kasei, Boehringer Ingelheim, Chugai, Eisai, and Mitsubishi-Tanabe; consulting fees from AbbVie, Janssen, Lilly, Novartis, Sanofi, and UCB; and received speakers\u2019 bureau fees from AbbVie, Asahi-Kasei, BMS, Chugai, Eisai, Janssen, Lilly, Mitsubishi-Tanabe, Novartis, and Pfizer. WPM has received grant\/research support from AbbVie, Novartis, Pfizer, and UCB Pharma; consulting fees, speaking fees, and\/or honoraria fees from AbbVie, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Medscape, Novartis, Peervoice, Pfizer, and UCB Pharma; is Chief Medical Officer of CARE Arthritis Limited; and has received royalties or licenses from Augurex for the 14-3-3eta diagnostic biomarker. IL-G, XiB, PW, KK, and AS are employees of AbbVie and may own stock or options. AD has received grant\/research support from AbbVie, BMS, Celgene, Lilly, MoonLake, Novartis, Pfizer, and UCB Pharma; and honoraria or consultation fees from AbbVie, BMS, Janssen, Lilly, Novartis, Pfizer, and UCB Pharma.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"197"}}