{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T06:51:07Z","timestamp":1790319067376,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2021,11,15]],"date-time":"2021-11-15T00:00:00Z","timestamp":1636934400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>This study assessed the efficacy and safety of upadacitinib (UPA), in combination with conventional synthetic disease\u2010modifying antirheumatic drugs (csDMARDs), in Chinese, Brazilian, and South Korean patients with active rheumatoid arthritis (RA) and an inadequate response (IR) to csDMARDs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients on stable csDMARDs were randomized (1:1) to once\u2010daily UPA 15\u00a0mg or matching placebo (PBO) for a 12\u2010week, double\u2010blind period. The primary endpoint was the proportion of patients achieving \u226520% improvement in American College of Rheumatology criteria (ACR20) at week 12.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 338 patients were randomized and treated, of whom 310 (91.7%) completed the double\u2010blind phase. The study met the primary endpoint of ACR20 at week 12 for UPA 15\u00a0mg vs PBO (71.6% vs 31.4%, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a0.001), with a treatment difference observed as early as week 1. All ranked and other key secondary endpoints, including more stringent responses such as ACR50, ACR70 (\u226550%\/70% improvement in ACR criteria), and Disease Activity Score in 28 joints using C\u2010reactive protein &lt;2.6, were met for UPA 15\u00a0mg vs PBO. The incidence of serious infections (2.4% vs 0.6%) and herpes zoster (HZ: 1.8% vs 0.6%) was higher with UPA 15\u00a0mg vs PBO. There was one case of venous thromboembolism reported in the UPA group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>UPA 15\u00a0mg in combination with csDMARDs demonstrated clinical and functional improvement and an acceptable safety profile over 12\u00a0weeks among patients from China, Brazil, and South Korea who had moderately to severely active RA and an IR to csDMARDs.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.14235","type":"journal-article","created":{"date-parts":[[2021,11,15]],"date-time":"2021-11-15T12:57:54Z","timestamp":1636981074000},"page":"1530-1539","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Upadacitinib in patients from China, Brazil, and South Korea with rheumatoid arthritis and an inadequate response to conventional therapy"],"prefix":"10.1111","volume":"24","author":[{"given":"Xiaofeng","family":"Zeng","sequence":"first","affiliation":[{"name":"Department of Rheumatology Peking Union Medical College Hospital (PUMCH) Chinese Academy of Medical Sciences  Beijing China"},{"name":"Key Laboratory of Rheumatology &amp; Clinical Immunology National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC\u2010DID)  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongbao","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Immunology Shanghai Changhai Hospital  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastiao C.","family":"Radominski","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Universidade Federal do Paran\u00e1  Curitiba Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauro","family":"Keiserman","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Pontifical Catholic University  Porto Alegre Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chang K.","family":"Lee","sequence":"additional","affiliation":[{"name":"Rheumatology Asan Medical Center  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Meerwein","sequence":"additional","affiliation":[{"name":"Immunology AbbVie Deutschland GmbH &amp; Co. KG  Ludwigshafen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Enejosa","sequence":"additional","affiliation":[{"name":"Immunology AbbVie Inc.  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunxia","family":"Sui","sequence":"additional","affiliation":[{"name":"Immunology AbbVie Inc.  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed\u2010Eslam F.","family":"Mohamed","sequence":"additional","affiliation":[{"name":"Immunology AbbVie Inc.  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Won","family":"Park","sequence":"additional","affiliation":[{"name":"Rheumatology School of Medicine Inha University  Incheon South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,11,15]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2008.06.011"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kel253"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31491-5"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39480"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-216655"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2174\/138161211798157658"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.23940"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.085787"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa035075"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2013.168"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar4594"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.berh.2014.10.017"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-med-051113-024537"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0701-9"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00281-017-0623-3"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1080\/1744666X.2016.1189826"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1517\/13543784.2012.690029"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s41927-018-0031-x"},{"key":"e_1_2_9_20_1","unstructured":"PharmaShots.AbbVie's Rinvoq (upadacitinib) receives ANVISA's approval for rheumatoid arthritis.2020. 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