{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T14:12:55Z","timestamp":1788012775451,"version":"build-2784847793"},"reference-count":24,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,3,29]],"date-time":"2017-03-29T00:00:00Z","timestamp":1490745600000},"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":[[2017,4]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of orally administered once\u2010daily peficitinib in combination with methotrexate (MTX) in patients with moderate\u2010to\u2010severe rheumatoid arthritis (RA) who had an inadequate response to MTX.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this multinational, phase IIb, randomized, double\u2010blind, placebo\u2010controlled, dose\u2010ranging trial, patients with RA (n\u2009=\u2009378) were treated with peficitinib 25 mg, 50 mg, 100 mg, or 150 mg plus MTX, or matching placebo plus MTX once daily for 12 weeks. The primary end point was the percentage of patients who met the American College of Rheumatology 20% improvement criteria (achieved an ACR20 response) at week 12.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>ACR20 response rates at week 12 were 43.9%, 61.5% (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05 versus placebo), 46.4%, 57.7%, and 44.4% in the peficitinib 25 mg, 50 mg, 100 mg, 150 mg, and placebo groups, respectively. Significant decreases from baseline in the Disease Activity Score in 28 joints using the C\u2010reactive protein level were seen in the peficitinib 50 mg (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05) and 150 mg (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.01) groups compared with placebo at week 12. Overall, the incidence of adverse events (AEs) was similar between peficitinib and placebo. The most common AEs were urinary tract infection (n\u2009=\u200922 [6%]), upper respiratory tract infection (n\u2009=\u200916 [4%]), and diarrhea (n\u2009=\u200916 [4%]). There were 3 cases of herpes zoster infection (2 in the peficitinib 100 mg group and 1 in the 150 mg group) and 2 cases of serious infection (viral infection in the peficitinib 100 mg group and erysipelas in the 150 mg group).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The ACR20 response rate in the group receiving peficitinib 50 mg plus MTX was significantly different compared with the rate in patients receiving placebo, but there were no apparent dose\u2010dependent responses, and the placebo response rate was high. Peficitinib plus MTX in patients with moderate\u2010to\u2010severe RA was well tolerated, with limited safety signals emerging.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.39955","type":"journal-article","created":{"date-parts":[[2016,10,16]],"date-time":"2016-10-16T22:59:18Z","timestamp":1476658758000},"page":"709-719","source":"Crossref","is-referenced-by-count":98,"title":["Peficitinib, a JAK Inhibitor, in the Treatment of Moderate\u2010to\u2010Severe Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate"],"prefix":"10.1002","volume":"69","author":[{"given":"A. J.","family":"Kivitz","sequence":"first","affiliation":[{"name":"Altoona Center for Clinical Research Duncansville Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. 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URL:http:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/pfizer_provides_update_on_global_regulatory_approvals_and_launches_of_xeljanz_tofacitinib_citrate_for_the_treatment_of_rheumatoid_arthritis."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.20494"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.33383"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.33419"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1112072"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2014-206478"},{"issue":"10","key":"e_1_2_8_12_1","article-title":"Filgotinib (GLPG0634), an oral JAK1 selective inhibitor is effective in combination with methotrexate in patients with active rheumatoid arthritis: results from a phase 2B dose ranging study [abstract]","volume":"67","author":"Westhovens R","year":"2015","journal-title":"Arthritis Rheumatol"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-eular.1758"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208279"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380602"},{"key":"e_1_2_8_16_1","article-title":"Peficitinib, a JAK inhibitor, in combination with limited conventional synthetic DMARDs in the treatment of moderate-to-severe rheumatoid arthritis","author":"MC Genovese","journal-title":"Arthritis Rheumatol"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780310302"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780350502"},{"key":"e_1_2_8_19_1","unstructured":"WebMD. 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