{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T20:02:01Z","timestamp":1781726521778,"version":"3.54.5"},"reference-count":41,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2023,1,30]],"date-time":"2023-01-30T00:00:00Z","timestamp":1675036800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,1,30]],"date-time":"2023-01-30T00:00:00Z","timestamp":1675036800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/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":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Rheumatol"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction\/objectives<\/jats:title><jats:p>Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by ongoing inflammation and degradation of synovial joints. The oral JAK inhibitor, upadacitinib, is approved for RA. We conducted an integrated safety analysis of upadacitinib 15\u00a0mg once daily (QD) in patients from Latin America (LATAM) versus the rest of the world (RoW).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Treatment-emergent adverse events (AEs) and laboratory data from six phase 3, randomized controlled trials, adjusted for upadacitinib 15\u00a0mg QD use in RA, were analyzed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 3209 patients received upadacitinib 15\u00a0mg QD for 7024 patient-years (PY). LATAM patients (<jats:italic>n<\/jats:italic>\u2009=\u2009725) had a mean upadacitinib exposure of 1518 PY. Baseline characteristics were generally similar between LATAM and RoW populations. AE rates (including serious\/opportunistic infections, tuberculosis, and herpes zoster) and deaths were comparable between populations. LATAM patients had lower serious AE rates per 100 PY (9.4 vs 14.0 E\/100 PY) and discontinuation-related AEs (3.9 vs 6.0 E\/100 PY) versus RoW. Rates of cardiovascular events were low (\u2264\u20090.5 E\/100 PY) and similar between populations. Malignancies, excluding non-melanoma skin cancer, were less common in the LATAM population versus RoW (0.2 vs 1.0 E\/100 PY). Laboratory abnormalities were similar between populations, with decreases in hemoglobin, lymphocyte, and neutrophil counts, and elevations in liver enzymes and creatine phosphokinase. Mean change from baseline in low- and high-density lipoprotein cholesterol was generally comparable between LATAM and RoW populations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Upadacitinib 15\u00a0mg QD demonstrated a consistent safety profile across LATAM and RoW patient populations, with no new safety risks observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration numbers<\/jats:title><jats:p>SELECT-EARLY, NCT02706873; SELECT-NEXT, NCT02675426; SELECT-COMPARE, NCT02629159; SELECT-MONOTHERAPY, NCT02706951; SELECT-BEYOND, NCT02706847; SELECT-CHOICE, NCT03086343.<\/jats:p><jats:table-wrap><jats:table><jats:tbody><jats:tr><jats:td colspan=\"2\"><jats:bold>Key Points<\/jats:bold><jats:italic>\u2022 This study assessed the safety of upadacitinib 15 mg in patients with rheumatoid arthritis from Latin America compared with patients from the rest of the world participating in the SELECT phase 3 program.<\/jats:italic><jats:italic>\u2022 Safety was generally similar between the two groups, including serious and opportunistic infections, tuberculosis, herpes zoster, and cardiovascular events. Malignancy, major adverse cardiovascular events, and venous thromboembolic events were infrequent in the Latin American patients.<\/jats:italic><jats:italic>\u2022 Consistent with the known safety profile of upadacitinib, serious infections, herpes zoster, and laboratory abnormalities were the most common safety events in the Latin American population.<\/jats:italic><\/jats:td><\/jats:tr><\/jats:tbody><\/jats:table><\/jats:table-wrap><\/jats:sec>","DOI":"10.1007\/s10067-023-06513-y","type":"journal-article","created":{"date-parts":[[2023,1,30]],"date-time":"2023-01-30T16:21:53Z","timestamp":1675095713000},"page":"1249-1258","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program"],"prefix":"10.1007","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9411-7493","authenticated-orcid":false,"given":"Adriana Maria","family":"Kakehasi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebasti\u00e3o Cezar","family":"Radominski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcos Daniel","family":"Baravalle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fedra Consuelo Irazoque","family":"Palazuelos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Conrado","family":"Garcia-Garcia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maysa Silva","family":"Arruda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Curi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meihua","family":"Qiao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Velez-Sanchez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Ignacio","family":"Vargas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,1,30]]},"reference":[{"key":"6513_CR1","doi-asserted-by":"publisher","first-page":"863","DOI":"10.1007\/s00296-020-04731-0","volume":"41","author":"K Almutairi","year":"2021","unstructured":"Almutairi K, Nossent J, Preen D et al (2021) The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. 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SCR has received grants for clinical studies from AbbVie, Bristol-Myers Squibb, and Lilly and speaker fees from AbbVie, Amgen, Janssen, Pfizer, and UCB. MDB has received medical fees as a Clinical Investigator from AbbVie, Galapagos, and GlaxoSmithKline. FCIP has received speaker fees from AbbVie, Pfizer, Bristol-Myers Squibb, and Janssen; consulting fees from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, and Pfizer; and medical fees as a Principal Investigator from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Pfizer, and Roche. CGG has received medical fees as a Principal Investigator from AbbVie. MSA, MC, JL, and MQ are employees of AbbVie and may own stock or options. PVS has received medical fees as a Principal Investigator from AbbVie. JIV has received medical fees as a Principal Investigator from AbbVie.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"All studies were conducted according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines, applicable regulations and guidelines governing clinical study conduct, and the Declaration of Helsinki. Study-related documents were reviewed and approved by independent ethics committees and institutional review boards. All patients provided written informed consent before participation in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}}]}}