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Axial involvement was determined by investigator judgement (yes or no; based on the totality of available clinical information, such as duration and characteristics of back pain, age of onset, and previous lab investigations and imaging, if available) alone, or investigator judgement and patient-reported outcome (PRO)-based criteria (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]\u2009\u2265\u20094 and BASDAI Q2\u2009\u2265\u20094). Efficacy outcomes that describe axial disease activity, including BASDAI endpoints, such as change from baseline in the overall BASDAI score or proportion of patients achieving BASDAI50 (\u2265\u200950% improvement from baseline), as well as Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints, such as mean change from baseline in overall ASDAS or proportion of patients achieving ASDAS inactive disease or low disease activity, were evaluated at weeks 12, 24, and 56, with nominal <jats:italic>P<\/jats:italic>-values shown. Treatment-emergent adverse events (TEAEs) are summarized through week 56.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>30.9% of patients in SELECT-PsA 1 and 35.7% in SELECT-PsA 2 had axial involvement by investigator judgement alone; 22.6% (SELECT-PsA 1) and 28.6% (SELECT-PsA 2) had axial involvement by investigator judgement and PRO-based criteria. Greater proportions of patients achieved BASDAI50 with UPA15 versus placebo using either criterion, and versus ADA using investigator judgement alone, at week 24 in SELECT-PsA 1 (investigator alone: UPA15, 59.0%, placebo, 26.9%, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001, ADA, 44.1%, <jats:italic>P<\/jats:italic>\u2009=\u20090.015; investigator and PRO-based: UPA15, 60.4%, placebo, 29.3%, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001, ADA, 47.1%, <jats:italic>P<\/jats:italic>\u2009=\u20090.074), with comparable findings in SELECT-PsA 2. Similar results were observed with UPA15 for additional BASDAI and ASDAS endpoints at weeks 12 and 24, with improvements maintained at week 56. Rates of TEAEs were generally similar across sub-groups irrespective of axial involvement status.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>PsA patients with axial involvement determined by predefined criteria showed greater BASDAI and ASDAS responses with UPA15 versus placebo, and numerically similar\/greater responses versus ADA. Safety results were generally comparable between patients with or without axial involvement.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov: SELECT-PsA 1, NCT03104400; SELECT-PsA 2, NCT0310437.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13075-023-03027-5","type":"journal-article","created":{"date-parts":[[2023,4,10]],"date-time":"2023-04-10T06:02:44Z","timestamp":1681106564000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9475-9362","authenticated-orcid":false,"given":"Xenofon","family":"Baraliakos","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberto","family":"Ranza","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"\u00d6st\u00f6r","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Ciccia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura C.","family":"Coates","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simona","family":"Rednic","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica A.","family":"Walsh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Douglas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tianming","family":"Gao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Kato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"In-Ho","family":"Song","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabiana","family":"Ganz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atul","family":"Deodhar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,4,10]]},"reference":[{"issue":"4","key":"3027_CR1","doi-asserted-by":"publisher","first-page":"880","DOI":"10.1016\/j.semarthrit.2021.06.006","volume":"51","author":"D Poddubnyy","year":"2021","unstructured":"Poddubnyy D, Jadon DR, Van den Bosch F, Mease PJ, Gladman DD. 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As per Good Clinical Practice (GCP), the trial protocols were approved by an independent ethics committee (IEC)\/institutional review board (IRB). A full list of the IECs and IRBs for SELECT-PsA 1 and SELECT-PsA 2 have been published previously []. All patients provided written informed consent.","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":"Financial arrangements of the authors with companies whose products may be related to the present manuscript are listed, as declared by the authors. XB: Received grant\/research support from, consultant for, and is a member of speaker bureaus for AbbVie, Bristol Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB. RR: Consultant for AbbVie, Janssen, Novartis, and Pfizer; and is a member of speaker bureaus for AbbVie, Janssen, Novartis, and Pfizer. A\u00d6: Consultant for AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, MSD, Novartis, Pfizer, and Roche; member of speaker bureaus for AbbVie, Bristol-Myers Squibb, Eli Lilly, Gilead, MSD, Novartis, Pfizer, and Roche. FC: Received grant\/research support from AbbVie, Celgene, Pfizer, Roche, and UCB; consultant for AbbVie, Bristol-Myers Squibb, Celgene, MSD, Novartis, Pfizer, Janssen, Sanofi, Sandoz, Galapagos, Sobi, and UCB; member of speaker bureaus for AbbVie, Bristol-Myers Squibb, Celgene, Novartis, Pfizer, and UCB. LCC: Received grant\/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB; consultant for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB; speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB. SR: Received grant\/research support from AbbVie, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Pfizer, and UCB; consultant for AbbVie, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, and Pfizer. JAW: Grants or consulting with AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB. KD: Employee of AbbVie and may hold stock or options. TG: Employee of AbbVie and may hold stock or options. KK: Employee of AbbVie and may hold stock or options. I-HS: Employee of AbbVie and may hold stock or options. FG: Employee of AbbVie and may hold stock or options. AD: Received research grants, consultancy fees, speaker fees, and other support (medical writing support) from Eli Lilly, Novartis, Pfizer and UCB; research grants, consultancy fees, and other support (medical writing support) from AbbVie, Bristol Myers Squibb, Eli Lilly, and UCB; research grants and consultancy fees from GlaxoSmithKline; consultancy fees and other support (medical writing support) from Janssen; consultancy fees from Bristol Myers Squibb and Celgene; and other support (medical writing support) from Amgen.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"56"}}