{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T05:20:16Z","timestamp":1789881616504,"version":"4.0.1"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2015,1,28]],"date-time":"2015-01-28T00:00:00Z","timestamp":1422403200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2015,2]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the efficacy and safety of oral decernotinib (VX\u2010509; Vertex Pharmaceuticals) monotherapy in a 12\u2010week, randomized, double\u2010blind, placebo\u2010controlled, dose\u2010ranging study of patients with rheumatoid arthritis (RA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Two hundred four adults with active RA who had been unsuccessfully treated with \u22651 disease\u2010modifying antirheumatic drug were administered placebo tablets or decernotinib twice a day at dosages of 25 mg, 50 mg, 100 mg, or 150 mg. Primary measures of efficacy at week 12 were the response rate according to the American College of Rheumatology 20% improvement criteria (ACR20) and mean change from baseline in the Disease Activity Score in 28 joints using the C\u2010reactive protein level (DAS28\u2010CRP).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At week 12, the ACR20 response rates were 39.0%, 61.0%, 65.0%, and 65.9% in the 25\u2010mg, 50\u2010mg, 100\u2010mg, and 150\u2010mg groups, respectively, and were significantly higher in the 50\u2010mg group (<jats:italic>P<\/jats:italic> = 0.007) and the 100\u2010mg and 150\u2010mg groups (<jats:italic>P<\/jats:italic> = 0.002) as compared to the response rates in the placebo group (29.3%). The mean change from baseline in DAS28\u2010CRP was greater in the 50\u2010mg, 100\u2010mg, and 150\u2010mg groups as compared to the placebo group (<jats:italic>P<\/jats:italic> &lt; 0.001). Decernotinib treatment resulted in higher ACR50 and ACR70 response rates, more patients with DAS28\u2010CRP scores &lt;2.6, and improvements in the Health Assessment Questionnaire disability index as compared to placebo. The most common adverse events in any decernotinib group were nausea (6.1%), headache (4.3%), an increase in levels of alanine aminotransferase (4.3%), and hypercholesterolemia (3.7%). In the groups receiving decernotinib, there was an increased risk of infections and increased liver transaminase levels.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Decernotinib was efficacious in improving clinical signs and symptoms of RA at week 12 at dosages of 50\u2013150 mg twice a day. Infections and increases in liver transaminase and lipid levels were noted as potential safety signals.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.38949","type":"journal-article","created":{"date-parts":[[2014,11,10]],"date-time":"2014-11-10T14:20:36Z","timestamp":1415629236000},"page":"334-343","source":"Crossref","is-referenced-by-count":105,"title":["A Randomized, Double\u2010Blind, Placebo\u2010Controlled, Twelve\u2010Week, Dose\u2010Ranging Study of Decernotinib, an Oral Selective JAK\u20103 Inhibitor, as Monotherapy in Patients With Active Rheumatoid Arthritis"],"prefix":"10.1002","volume":"67","author":[{"given":"Roy M.","family":"Fleischmann","sequence":"first","affiliation":[{"name":"University of Texas Southwestern Medical Center Dallas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nemanja S.","family":"Damjanov","sequence":"additional","affiliation":[{"name":"University of Belgrade School of Medicine Belgrade Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan J.","family":"Kivitz","sequence":"additional","affiliation":[{"name":"Altoona Center for Clinical Research Duncansville Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Legedza","sequence":"additional","affiliation":[{"name":"Vertex Pharmaceuticals Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Hoock","sequence":"additional","affiliation":[{"name":"Vertex Pharmaceuticals Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Kinnman","sequence":"additional","affiliation":[{"name":"Vertex Pharmaceuticals Eysins Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,1,28]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kes122"},{"key":"e_1_2_8_3_1","first-page":"1037","article-title":"Diagnosis and management of rheumatoid arthritis","volume":"72","author":"Rindfleisch JA","year":"2005","journal-title":"Am Fam Physician"},{"key":"e_1_2_8_4_1","first-page":"234","article-title":"Improved health\u2010related quality of life with effective disease\u2010modifying antirheumatic drugs: evidence from randomized controlled trials","volume":"14","author":"Strand V","year":"2008","journal-title":"Am J Manag Care"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60826-4"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.30129"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2011-200595"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.126573"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61424-X"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.33383"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1109071"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1112072"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.24567"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-065X.2008.00754.x"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S25426"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-065X.2008.00644.x"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202576"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2005.050385"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2005.037929"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780390202"},{"key":"e_1_2_8_21_1","first-page":"2415","article-title":"JAK3: a novel JAK kinase associated with terminal differentiation of hematopoietic cells","volume":"9","author":"Rane SG","year":"1994","journal-title":"Oncogene"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1186\/gb-2004-5-12-253"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.270.5237.797"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1038\/377065a0"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780310302"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380602"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380107"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.084459"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780230202"},{"key":"e_1_2_8_30_1","first-page":"S1051","article-title":"Herpes zoster and tofacitinib therapy in patients with rheumatoid arthritis","volume":"64","author":"Winthrop KL","year":"2012","journal-title":"Arthritis Rheum"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1038\/ni.1701"}],"container-title":["Arthritis &amp; Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fart.38949","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.38949","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/art.38949","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.38949","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T18:44:48Z","timestamp":1759949088000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/art.38949"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,1,28]]},"references-count":30,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2015,2]]}},"alternative-id":["10.1002\/art.38949"],"URL":"https:\/\/doi.org\/10.1002\/art.38949","archive":["Portico"],"relation":{},"ISSN":["2326-5191","2326-5205"],"issn-type":[{"value":"2326-5191","type":"print"},{"value":"2326-5205","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,1,28]]}}}