{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T04:18:06Z","timestamp":1793765886194,"version":"4.6.1"},"reference-count":37,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2020,9,8]],"date-time":"2020-09-08T00:00:00Z","timestamp":1599523200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/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":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>The SELECT\u2010EARLY trial was undertaken to study the effect of upadacitinib, an oral, reversible Janus kinase 1\u2013selective inhibitor, as monotherapy in patients with predominantly early rheumatoid arthritis who were naive for or had limited exposure to methotrexate (MTX).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients (n = 947) were randomized 1:1:1 to receive once\u2010daily doses of upadacitinib 15 mg or 30 mg or weekly MTX (7.5\u201320 mg\/week) for 24 weeks. The primary end points were the proportion of patients who met the American College of Rheumatology 50% (ACR50) improvement criteria at week 12, and the proportion in whom a Disease Activity Score in 28 joints using the C\u2010reactive protein level (DAS28\u2010CRP) of &lt;2.6 was achieved at week 24. Data are presented through week 24.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At baseline, the median disease duration was 0.5 years (range 0\u201344 years). A total of 840 patients (89%) completed 24 weeks of treatment. The study met both primary end points for upadacitinib 15 mg and 30 mg versus MTX (ACR50 was achieved at week 12 in 52% and 56% of patients, respectively, versus 28% [<jats:italic>P<\/jats:italic> &lt; 0.001], and DAS28\u2010CRP &lt;2.6 was achieved at week 24 in 48% and 50% of patients, respectively, versus 19% [<jats:italic>P<\/jats:italic> &lt; 0.001]). Statistically significant and clinically meaningful improvements in multiple patient\u2010reported outcomes (PROs) were recorded for both upadacitinib doses versus MTX. Overall, 88% of patients receiving upadacitinib 15 mg and 89% of patients receiving 30 mg, respectively, had no radiographic progression (modified total Sharp score \u22640) compared to 78% of those receiving MTX (<jats:italic>P<\/jats:italic> &lt; 0.01). Through week 24, the frequency of treatment\u2010emergent adverse events was similar between the MTX arm (65%) and upadacitinib 15 mg arm (64%), but was slightly higher in the upadacitinib 30 mg arm (71%). Six deaths were reported (2 in the upadacitinib 15 mg arm, 3 in the upadacitinib 30 mg arm, and 1 in the MTX arm).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our findings indicate that patients receiving either dose of upadacitinib monotherapy experienced significant improvements in clinical, radiographic, and PROs compared to patients receiving MTX.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.41384","type":"journal-article","created":{"date-parts":[[2020,7,8]],"date-time":"2020-07-08T03:59:38Z","timestamp":1594180778000},"page":"1607-1620","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":209,"title":["Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate\u2010Naive Patients With Moderately\u2010to\u2010Severely Active Rheumatoid Arthritis (SELECT\u2010EARLY): A Multicenter, Multi\u2010Country, Randomized, Double\u2010Blind, Active Comparator\u2013Controlled Trial"],"prefix":"10.1002","volume":"72","author":[{"given":"Ronald","family":"van Vollenhoven","sequence":"first","affiliation":[{"name":"Amsterdam University Medical Center  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsutomu","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Keio University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aileen L.","family":"Pangan","sequence":"additional","affiliation":[{"name":"AbbVie, Inc.  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